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Asset Brief

Remestemcel-L

MSB·Mesoblast·Chronic heart failure·Phase 3·[ TODO: fill in ]

Plain-language Brief

The trial in plain terms

The disease: Chronic heart failure is a long-term condition in which the heart cannot pump blood efficiently enough to meet the body's needs. It affects millions of people worldwide and is associated with frequent hospitalisation and high mortality. Despite available drug therapies and devices, many patients continue to progress and have limited options. Inflammation and damage to heart muscle cells are thought to contribute to disease worsening in a subset of patients.
What the asset is trying to do: Remestemcel-L consists of allogeneic (donor-derived) mesenchymal stem cells (MSCs) expanded from donor bone marrow and supplied as an off-the-shelf, cryopreserved product (per Ryoncil US prescribing information). MSCs are not thought to permanently engraft in tissue; instead they are understood to act transiently by releasing signalling molecules that modulate inflammation and immune responses at the site of injury. This approach differs from standard drug therapies, which target specific pathways such as the renin-angiotensin system, and from gene therapy or autologous cell approaches that require patient-specific manufacturing.
Efficacy benchmarks in this setting: In the chronic heart failure setting, approved standard-of-care therapies have established efficacy benchmarks against which new entrants are assessed. For context, sacubitril/valsartan (Entresto) reduced the composite of cardiovascular death or first heart failure hospitalisation to 21.8% versus 26.5% for enalapril over approximately 27 months in the PARADIGM-HF trial (McMurray et al, New England Journal of Medicine, 2014). Dapagliflozin (Farxiga) reduced the composite of worsening heart failure or cardiovascular death in patients with reduced ejection fraction in the DAPA-HF trial (McMurray et al, New England Journal of Medicine, 2019). Mesoblast's own DREAM-HF Phase 3 trial of rexlemestrocel-L (a separate MSC candidate from the same platform) in chronic heart failure did not meet its primary endpoint of reducing recurrent non-fatal decompensated heart failure events, though a pre-specified subgroup analysis showed a signal in patients with elevated inflammation markers (per Mesoblast ASX announcement, November 2021). Any early-stage figures reported for remestemcel-L in heart failure are not statistically comparable to these approved-therapy results, which come from large, adequately powered randomised controlled trials.

Trial Design

Design summary

Phase: Phase 3
Design type: [ TODO: fill in ]
Primary endpoint: [ TODO: fill in ]
Key secondary endpoints: [ TODO: fill in ]
Enrolment target: [ TODO: fill in ]
Current enrolment status: [ TODO: fill in ]
Sites: [ TODO: fill in ]
Expected readout window: [ TODO: fill in ]

Asset Track Record

Did MSB deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

20 July 2026regulatory decisionN/A N/A — Mesoblast CEO Makes Investment to Increase Share Ownershiphitsrc
14 July 2026data readoutPivotal Phase 3 Trial in CLBP Achieves 300 Treated Patientshit · positivesrc ASX ↗
30 June 2026regulatory decisionrexlemestrocel-L FDA — Receives FDA BLA Filing Number and Requests Modular Reviewhit · positivesrc ASX ↗
30 June 2026regulatory decisionRemestemcel-L US BLA resubmission pathwayoverdueASX ↗
24 June 2026regulatory decisionRyoncil (remestemcel-L-rknd) FDA — Mesoblast Draws US$50M from Five-Year Non-Dilutive Facilityhit · positivesrc ASX ↗
13 Apr 2026data readoutResults posted — Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infhitsrc ASX ↗
13 Apr 2026data readoutResults posted — A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Shitsrc
13 Apr 2026data readoutResults posted — Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyahitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for Remestemcel-L and peers

Remestemcel-L's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for Remestemcel-L. Showing past 6 months and next 12 months · 11 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation

Trial design comparison

How Remestemcel-L reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
Remestemcel-L	Mesoblast	Mesenchymal Stem Cell	Phase 3[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil	Kumamoto University

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 2 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Mesenchymal Stem CellAllo MSC	Off-the-shelf	Batch (donor)	Ryoncil (GvHD only)	Transient	Low
Fc Fusion ProteinFc-fusion trap	Off-the-shelf	Biologic	Eylea / Vabysmo class	Dosing-interval driven	High (incumbents)

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for Remestemcel-L yet. Broker coverage of Mesoblast is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did MSB deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

20 July 2026regulatory decisionN/A N/A — Mesoblast CEO Makes Investment to Increase Share Ownershiphitsrc
14 July 2026data readoutPivotal Phase 3 Trial in CLBP Achieves 300 Treated Patientshit · positivesrc ASX ↗
30 June 2026regulatory decisionrexlemestrocel-L FDA — Receives FDA BLA Filing Number and Requests Modular Reviewhit · positivesrc ASX ↗
30 June 2026regulatory decisionRemestemcel-L US BLA resubmission pathwayoverdueASX ↗
24 June 2026regulatory decisionRyoncil (remestemcel-L-rknd) FDA — Mesoblast Draws US$50M from Five-Year Non-Dilutive Facilityhit · positivesrc ASX ↗
13 Apr 2026data readoutResults posted — Safety Study of Allogeneic Mesenchymal Precursor Cell Infusion in Myocardial Infhitsrc ASX ↗
13 Apr 2026data readoutResults posted — A Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Shitsrc
13 Apr 2026data readoutResults posted — Placebo-controlled Study to Evaluate Rexlemestrocel-L Alone or Combined With Hyahitsrc ASX ↗

Class Catalyst Calendar

What's landed, what's next for Remestemcel-L and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation

Trial design comparison

How Remestemcel-L reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
Remestemcel-L	Mesoblast	Mesenchymal Stem Cell	Phase 3[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	[ TODO: fill in ]	0
Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil	Kumamoto University

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 2 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Mesenchymal Stem CellAllo MSC	Off-the-shelf	Batch (donor)	Ryoncil (GvHD only)	Transient	Low
Fc Fusion ProteinFc-fusion trap	Off-the-shelf	Biologic	Eylea / Vabysmo class	Dosing-interval driven	High (incumbents)

Remestemcel-Ln = 0

Mesoblast·Mesenchymal Stem Cell·Phase 3·[ TODO: fill in ]

Design: [ TODO: fill in ]
Primary endpoint: [ TODO: fill in ]
Dosing: [ TODO: fill in ]
Eligibility: [ TODO: fill in ]

Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandiln = —

Kumamoto University·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Acetazolamide Per os for Decompensation of Heart Failuren = —

Samara State Medical University·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammationn = —

Dongying Zhang·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Disease Patients With Reduced Ejection Fraction Heart Failuren = —

Evi Liliek Wulandari·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failuren = —

Raffaele De Caterina·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Effect of Sacubitril and Valsartan on Heart Function in Chronic Hemodialysis Patients With HFpEFn = —

University Clinical Hospital Mostar·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type IIn = —

Fazaia Ruth Pfau Medical College·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiencyn = —

China-Japan Friendship Hospital·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Studyn = —

Hospital de Messejana Dr. Carlos Alberto Studart Gomes·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)n = —

Tomsk National Research Medical Center of the Russian Academy of Sciences·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Qishenyiqi for Ventricular Remodeling After Myocardial Infarctionn = —

Qilu Hospital of Shandong University·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysisn = —

Nicholas Carlson·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Allograft Dysfunction in Heart Transplantn = —

Paul Kim·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Devicen = —

Columbia University·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Vericiguat and Reverse Remodeling Indices in Heart Failuren = —

University Medical Centre Ljubljana·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Diseasen = —

National Taiwan University Hospital·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Diseasen = —

National Taiwan University Hospital·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Metoprolol in Patients With HFrEF and COPDn = —

Xiangya Hospital of Central South University·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Recordn = —

Herlev and Gentofte Hospital·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failuren = —

AstraZeneca·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Scoren = —

Boston Children's Hospital·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

S086 Tablets for Chronic Heart Failure With Reduced Ejection Fractionn = —

Shenzhen People's Hospital·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicinen = —

Niguarda Hospital·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patientsn = —

Fundación para la Investigación del Hospital Clínico de Valencia·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fractionn = —

John Paul II Hospital, Krakow·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKDn = —

University Medical Center Groningen·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fractionn = —

Cytokinetics·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infectionsn = —

X4 Pharmaceuticals·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenaln = —

University of Monastir·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failuren = —

Pharmacosmos A/S·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Diseasen = —

Alessandro Doria·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Dapagliflozin for Cardio-renal Protection After ICU Dischargen = —

Assistance Publique - Hôpitaux de Paris·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)n = —

Eli Lilly and Company·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heartn = —

Boehringer Ingelheim·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction.n = —

Tongji Hospital·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Communication During Hospitalization About Resuscitation Trialn = —

University of Vermont·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failuren = —

Jens D Hove, MD,PHD·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)n = —

CSL Behring·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive Heart Failure Patients with an LVEF of ≤40% with Fresh, Uncultured, Autologous, Adipose-derived Regenerative Cells Isolated from Lipoaspirate.n = —

Ralf Rothoerl·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Ertugliflozin in Chronic Heart Failuren = —

Yale University·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of JK07 in Patients With Chronic Heart Failuren = —

Salubris Biotherapeutics Inc·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fractionn = —

Akros Pharma Inc.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Studyn = —

Maximo Agustin Schiavone·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammationn = —

University of Texas Southwestern Medical Center·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Endocalyx for Heart Failuren = —

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failuren = —

Tasly Pharmaceutical Group Co., Ltd·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Swedish Cardiac And Renal Failure Study-1n = —

Karolinska Institutet·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Chronic Exogenous Ketosis in HFpEFn = —

Duke University·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure (BELACOEUR)n = —

Nantes University Hospital·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)n = —

University Medical Center Groningen·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

KU
Prospective Study of End Stage Renal Disease Patients With Coronary Artery Disease Treated by Oral Nicorandil
Phase 4
Kumamoto University·Active, not recruiting·Primary completion 1 June 2011·NCT01475123
1 site
268 enrolledstalled · 318d·PI: Hisao Ogawa
SS
Acetazolamide Per os for Decompensation of Heart Failure
Phase 4
Samara State Medical University·Recruiting·Primary completion 28 Aug 2025·NCT05802849
1 site
PI: Dmitriy Duplyakov
DZ
Colchicine in Patients With Heart Failure With Preserved Ejection Fraction and Inflammation
Phase 4
Dongying Zhang·Not yet recruiting·Primary completion 31 Dec 2025·NCT06604611
1 site
PI: Junlong Chen
EL
Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Disease Patients With Reduced Ejection Fraction Heart Failure
Phase 4
Evi Liliek Wulandari·Recruiting·Primary completion 31 Dec 2025·NCT07259512
1 site
RD
Effect of Oral sucRosomIal Iron on exerciSE Capacity and Quality of Life in Patients With Heart Failure
Phase 4
Raffaele De Caterina·Recruiting·Primary completion 14 Mar 2026·NCT06270498
1 site
PI: Gabriele Masini
UC
The Effect of Sacubitril and Valsartan on Heart Function in Chronic Hemodialysis Patients With HFpEF
Phase 4
University Clinical Hospital Mostar·Not yet recruiting·Primary completion 10 Apr 2026·NCT07417215
1 site
52 enrolled
FR
Effect of Empagliflozin on Quality of Life in Chronic Heart Failure Patients With Diabetes Mellitus Type II
Phase 4
Fazaia Ruth Pfau Medical College·Recruiting·Primary completion 1 June 2026·NCT06706791
1 site
PIs: Tooba Riaz, Asghar Mehdi, MBBS Phd, Sadia Khan, +2
CF
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Phase 4
China-Japan Friendship Hospital·Recruiting·Primary completion 30 Sept 2026·NCT06427343
1 site
PI: Jingyi Ren
HD
Spironolactone Alternate Dosing vs Finerenone in Elevated Potassium - K Safety Study
Phase 4
Hospital de Messejana Dr. Carlos Alberto Studart Gomes·Not yet recruiting·Primary completion 1 Oct 2026·NCT07523867
TN
The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)
Phase 4
Tomsk National Research Medical Center of the Russian Academy of Sciences·Recruiting·Primary completion 1 Dec 2026·NCT05793996
1 site
PI: Alla A. Garganeeva, M.D
QH
Qishenyiqi for Ventricular Remodeling After Myocardial Infarction
Phase 4
Qilu Hospital of Shandong University·Not yet recruiting·Primary completion 31 Dec 2026·NCT06699407
3 sites
NC
The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis
Phase 4
Nicholas Carlson·Recruiting·Primary completion 1 Jan 2027·NCT03862859
13 sites
PIs: Anne-Lise Kamper, MD DMSc, Christian Torp-Pedersen, Prof MD DMSc, Ditte Hansen, +7
PK
Allograft Dysfunction in Heart Transplant
Phase 4
Paul Kim·Recruiting·Primary completion 1 Jan 2027·NCT03102125
1 site
CU
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Phase 4
Columbia University·Recruiting·Primary completion 1 Apr 2027·NCT06655376
3 sites
PI: Nir Uriel
UC
Vericiguat and Reverse Remodeling Indices in Heart Failure
Phase 4
University Medical Centre Ljubljana·Recruiting·Primary completion 31 July 2027·NCT07405944
1 site
PIs: Gregor Poglajen, Tine Bajec, Gregor Zemljič, +7
NT
Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease
Phase 4
National Taiwan University Hospital·Recruiting·Primary completion 31 Dec 2027·NCT06249932
2 sites
PIs: Donna Shu-Han Lin, Chih-Cheng Wu, MD. PhDshared KOL · Lin +1
NT
EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
Phase 4
National Taiwan University Hospital·Recruiting·Primary completion 31 Dec 2027·NCT06249945
2 sites
PIs: Donna SH Lin, Chih-Cheng Wu, MD. PhD, Chih-Cheng Wushared KOL · Lin +2
XH
Metoprolol in Patients With HFrEF and COPD
Phase 4
Xiangya Hospital of Central South University·Not yet recruiting·Primary completion 1 Feb 2028·NCT06825728
0 sites
HA
A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record
Phase 4
Herlev and Gentofte Hospital·Recruiting·Primary completion 31 Dec 2028·NCT06642272
12 sites
PI: Morten Schou
A
Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
Phase 4
AstraZeneca·Recruiting·Primary completion 16 Aug 2030·NCT06651970
23 sites
BC
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
Phase 3
Boston Children's Hospital·Active, not recruiting·Primary completion 17 Apr 2023·NCT03386539
SP
S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
Phase 3
Shenzhen People's Hospital·Recruiting·Primary completion 31 Dec 2025·NCT05553886
1 site
NH
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
Phase 3
Niguarda Hospital·Recruiting·Primary completion 2 May 2026·NCT06158698
10 sites
PIs: Enrico Ammirati, Francesco Loffredo, Luciano Potena, +8
FP
A Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients
Phase 3
Fundación para la Investigación del Hospital Clínico de Valencia·Recruiting·Primary completion 30 Dec 2026·NCT06578078
6 sites
JP
The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction
Phase 3
John Paul II Hospital, Krakow·Recruiting·Primary completion 1 Mar 2027·NCT05508035
1 site
UC
The RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD
Phase 3
University Medical Center Groningen·ENROLLING_BY_INVITATION·Primary completion 1 July 2027·NCT05374291
102 sites
PI: Ron Gansevoort
C
Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
Phase 3
Cytokinetics·Recruiting·Primary completion 1 Sept 2027·NCT06736574
188 sites·5 top centres: Stanford, Columbia / NYP, +3
X
A Study of Mavorixafor in Participants With Congenital and Acquired Primary Autoimmune and Idiopathic Chronic Neutropenic Disorders Who Are Experiencing Recurrent and/or Serious Infections
Phase 3
X4 Pharmaceuticals·Recruiting·Primary completion 1 Sept 2027·NCT06056297
114 sites·1 top centre: Duke
UO
Outpatient Hypertonic Saline and Loop Diuretic Combination Therapy in Cardiorenal
Phase 3
University of Monastir·Not yet recruiting·Primary completion 30 Nov 2027·NCT07596329
PA
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
Phase 3
Pharmacosmos A/S·Recruiting·Primary completion 1 Dec 2027·NCT06929806
1 site
AD
Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease
Phase 3
Alessandro Doria·Recruiting·Primary completion 1 Dec 2028·NCT06217302
19 sites·2 top centres: Stanford, Northwestern
PIs: Michael Mauer, David Cherney, Marina Basina, +44
AP
Dapagliflozin for Cardio-renal Protection After ICU Discharge
Phase 3
Assistance Publique - Hôpitaux de Paris·Recruiting·Primary completion 15 Jan 2029·NCT07025629
2 sites
PIs: Alexandre Mebazaa, MD-PHD, François DEPRET, MD-PHD
EL
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Phase 3
Eli Lilly and Company·Active, not recruiting·Primary completion 1 Feb 2029·NCT06383390
743 sites
BI
A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart
Phase 3
Boehringer Ingelheim·Recruiting·Primary completion 4 Feb 2029·NCT06935370
635 sites·1 top centre: Mayo Clinic
TH
Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction.
Phase 3
Tongji Hospital·Not yet recruiting·Primary completion 31 Dec 2030·NCT07288749
1 site
UO
Communication During Hospitalization About Resuscitation Trial
PHASE2/PHASE3
University of Vermont·Active, not recruiting·Primary completion 1 Mar 2023·NCT02984124
4 sites
182 enrolled·PI: Renee Stapleton
JD
Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
PHASE2/PHASE3
Jens D Hove, MD,PHD·Recruiting·Primary completion 30 Dec 2027·NCT06423599
1 site
CB
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis (POSIBIL6ESKD)
PHASE2/PHASE3
CSL Behring·Recruiting·Primary completion 22 May 2029·NCT05485961
547 sites·3 top centres: Vanderbilt, Princess Margaret, +1
RR
Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive Heart Failure Patients with an LVEF of ≤40% with Fresh, Uncultured, Autologous, Adipose-derived Regenerative Cells Isolated from Lipoaspirate.
Phase 2
Ralf Rothoerl·Recruiting·Primary completion 31 Oct 2025·NCT06705023
1 site
PI: Abay Baigenzhin, Prof Dr
YU
Ertugliflozin in Chronic Heart Failure
Phase 2
Yale University·Recruiting·Primary completion 30 Dec 2025·NCT04438213
1 site
PI: Jeffrey Testani
SB
Study of JK07 in Patients With Chronic Heart Failure
Phase 2
Salubris Biotherapeutics Inc·Recruiting·Primary completion 31 Dec 2025·NCT06369298
62 sites
AP
Evaluate Efficacy, Safety and Tolerability of JTT-861 in Subjects With Heart Failure With Reduced Ejection Fraction
Phase 2
Akros Pharma Inc.·Active, not recruiting·Primary completion 1 May 2026·NCT06017609
75 sites
314 enrolled
MA
Cardiovascular Effects of SGLT2 Inhibitors in Hemodialysis Patients: A Phase 2 Randomized Study
Phase 2
Maximo Agustin Schiavone·Recruiting·Primary completion 1 July 2026·NCT06929169
1 site
PI: Carlos E Castellaro
UO
Efficacy of LoDoCo in Improving Exercise Capacity Among Patients With HFpEF and Inflammation
Phase 2
University of Texas Southwestern Medical Center·Recruiting·Primary completion 31 July 2026·NCT06130059
1 site
PI: Ambarish Pandey
AM
Endocalyx for Heart Failure
Phase 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)·Recruiting·Primary completion 1 Sept 2026·NCT05966415
1 site
PI: Rik Olde Engberink
TP
Efficacy and Safety of Jia Shen Tablets in Chronic Heart Failure
Phase 2
Tasly Pharmaceutical Group Co., Ltd·Not yet recruiting·Primary completion 31 Dec 2026·NCT06669169
1 site
KI
Swedish Cardiac And Renal Failure Study-1
Phase 2
Karolinska Institutet·Recruiting·Primary completion 1 Feb 2027·NCT07029503
1 site·1 top centre: Karolinska
PIs: Krister Lindmark, Carl Haggård, Karl Wärnberg, +1
DU
Chronic Exogenous Ketosis in HFpEF
Phase 2
Duke University·ENROLLING_BY_INVITATION·Primary completion 1 June 2027·NCT06937320
1 site·1 top centre: Duke
PI: Senthil Selvaraj
NU
Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure (BELACOEUR)
Phase 2
Nantes University Hospital·Recruiting·Primary completion 1 Jan 2028·NCT04180085
4 sites
UC
Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
Phase 2
University Medical Center Groningen·Recruiting·Primary completion 1 Feb 2028·NCT07304817
2 sites
PIs: David Smeijers, Kevin Damman, Associate Professor