Table 7. Ongoing drug trials in chronic heart failure/acute myocardial infarction.
| Class of drug | Trial name (NCT#) | Drug name | Phase | Patient number | Comparison | Primary endpoint | Estimated completion date |
| SGLT2 i | A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (EMPACT-MI) (NCT04509674). | Empagliflozin | 3 | 6500 | vs. placebo | All-cause death + HHF | March 31, 2023 |
| Dapagliflozin Effects on Cardiovascular Events in Patients With an Acute Heart Attack (DAPA-MI) (NCT04564742). | Dapagliflozin | 3 | 6400 | vs. placebo | CV death + HHH | September 22, 2023 | |
| Effect of Ertugliflozin on Cardiac Function in Diabetes (ERTU-GLS) (NCT03717194) | Ertugliflozin | 3 | 120 | vs. placebo | Change of global longitudinal strain after 24 weeks’ treatment | December 31, 2022 | |
| Ertugliflozin in Chronic Heart Failure (NCT04438213). | Ertugliflozin | 2 | 90 | Ertugliflozin, metolazone, or a placebo | Change in urine sodium concentration and total body water from baseline to day 7 to 6 weeks | July 2023 | |
| GLP1 RA | Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity (STEP-HFpEF) (NCT04788511). | Semaglutide | 3 | 516 | vs. placebo | Changes in KCCQ clinical summary score and body weight | April 25, 2023 |
| Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes (STEP HFpEF DM) (NCT04916470). | Semaglutide | 3 | 610 | vs. placebo | Changes in KCCQ clinical summary score and body weight | August 8, 2023 | |
| GLP1 RA/GIP | A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction and Obesity (SUMMIT) (NCT04847557). | Tirzepatide | 3 | 700 | vs. placebo | Composite of all-cause death, heart failure events, 6MWD and KCCQ Clinical Summary Score | November 22, 2023 |
| ARNI | Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF) (NCT03988634). | Sacubitril/valsartan | 3 | 450 | Sacubitril/valsartan vs. valsartan | Proportional change in NT-proBNP from baseline to the average of weeks 4 and 8 | October 31, 2022 |
| MRA | Study to Evaluate the Efficacy and Safety of Finerenone on Morbidity & Mortality in Participants With Heart Failure and Left Ventricular Ejection Fraction Greater or Equal to 40% (FINEARTS-HF) (NCT04435626). | Finerenone | 3 | 5500 | vs. placebo | CV death + HHF | May 2, 2024 |
| Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease (MIRACLE) (NCT04595370). | AZD9977 | 2 | 500 | AZD9977 + dapagliflozin vs. dapagliflozin | Percent change from baseline in UACR at 12 weeks | June 26, 2023 | |
| sGC activator | Vericiguat in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) (VICTOR) (NCT05093933). | Vericiguat | 3 | 6000 | vs. placebo | CV death + HHF | June 15, 2025 |
| Myeloperoxidase (MPO) inhibitor | Study to Evaluate the Efficacy and Safety of AZD4831 in Participants With Heart Failure With Left Ventricular Ejection Fraction > 40% (ENDEAVOR) (NCT04986202). | AZD4831 | 2b and 3 | 1485 | vs. placebo | 1. KCCQ-Total Symptom Score change from baseline at 16 and 24 weeks. 2. 6MWD change from baseline at 16 and 24 weeks | November 13, 2024 |
| Others | A Study of Mavacamten in Participants With HFpEF and Elevation of NT-proBNP With or Without Elevation of cTnT (EMBARK-HFpEF) (NCT04766892). | Mavacamten | 2 | 35 | Single arm | NT-proBNP and cTnT levels at 26 weeks | April 30, 2023 |
| A Study of Ponsegromab in People With Heart Failure (GARDEN TIMI 74) (NCT05492500). | Ponsegromab (growth differentiation factor 15) | 2 | 416 | vs. placebo | Change from baseline in KCCQ 23 Clinical Summary Score | September 13, 2024 | |
| Effectiveness of CRD-740 in Heart Failure (CARDINAL-HF) (NCT05409183). | CRD-740 (a PDE9 inhibitor) | 2 | 660 | vs. placebo | Part A: The change in plasma cGMP at Week 4. Part B: The change in NT-proBNP at Week 12 | January 2024 | |
| REGN5381 in Adult Heart Failure Patients With Elevated Pulmonary Capillary Wedge Pressure and Reduced Left Ventricular Ejection Fraction. | REGN5381 (Natriuretic peptide receptor 1 agonist) | 2 | 80 | vs. placebo | Incidence and severity of treatment-emergent adverse events (TEAEs) | November 22, 2023 | |
| Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction (HF-REVERT) (NCT05350969). | CDR132L (Cardiac miR-132 inhibitor) | 2 | 280 | vs. placebo | Percent change in Left Ventricular End-Systolic Volume (LVESVI) at Month 6 | November 30, 2024 | |
| Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF (NCT05284617). | HU6 (Controlled Metabolic Accelerator) | 2 | 62 | vs. placebo | Calculating the PK parameter Cmax | October 30, 2023 | |
| A Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of Intravenous APD418 in Adult Participants With Heart Failure With Reduced Ejection Fraction. | APD418 (beta3-Adrenergic Receptor Antagonist) | 2 | 80 | vs. placebo | Change from baseline in cardiac index measured by right heart catheterization | March 2023 | |
| A Study to Assess the Safety, Tolerability and Efficacy of IONIS-AGT-LRx in Participants With Chronic Heart Failure With Reduced Ejection Fraction (ASTRAAS-HF). | IONIS-AGT-LRx (ASO directed to hepatocyte-derived angiotensinogen) | 2 | 72 | vs. placebo | Percent change in plasma AGT concentration from baseline to study day 85 | January 2023 | |
| OPtimizing Aldosterone Receptor Antagonist Therapy by Sodium Zirconium Cyclosilicate in Heart Failure (OPRA-HF) (NCT04789239). | Sodium zirconium cyclosilicate | 2 | 230 | vs. placebo | Optimization of MRA usage by Sodium Zirconium Cyclosilicate in HFrEF | June 30, 2024 | |
| Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction (MUSIC-HFrEF1) (NCT04703842). | SRD-001 | 2 | 56 | vs. placebo | Change of NYHA, KCCQ, 6MWT, LV function, HF-related events at month 6 and month 12 | December 2028 | |
| A Phase IIa Clinical Trial on TSG-01 in the Treatment of Chronic Heart Failure in Patients With Coronary Heart Disease. | TSG-01 | 2 | 90 | vs. placebo | NYHA and 6MWT at week 12 | May 7, 2022 | |
| Evaluate the Effect of Injectable Neucardin on the Cardiac Function of Subjects With Chronic Systolic Heart Failure (NCT04468529). | Neucardin | 3 | 140 | vs. placebo | Left Ventricular End-Systolic Volume Index (LVESVI) change from baseline on day 30 | May 20, 2022 | |
| Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy (NCT04083339). | AT-001 (Aldose Reductase Inhibitor) | 3 | 675 | vs. placebo | Peak VO2 during cardio-pulmonary exercise test at month 15 | December 2025 | |
| Study to Evaluate Effects of INL1 in Patients With Heart Failure and Reduced Ejection Fraction (TRACER-HF) (NCT03875183). | INL1 | 2 | 200 | vs. placebo | Change in NT-proBNP at week 12 | January 2023 | |
| Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure (NCT03388593). | RhNRG-1 (recombinant human neuregulin-1) | 3 | 1600 | vs. placebo | All-cause death | February 2023 | |
| Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency (HEART-FID) (NCT03037931). | Ferric carboxymaltose | 3 | 3068 | vs. placebo | 1. All-cause death. 2. Heart failure hospitalization. 3. Change in 6MWT distance | June 2023 |
AGT, angiotensinogen; ARNI, angiotensin receptor neprilysin inhibitor; Cmax, maximum serum concentration; cTnT, cardiac troponin T; CV, cardiovascular; GIP, gastric inhibitory polypeptide; GLP1 RA, glucagon-like peptide-1 receptor agonist; HF, heart failure; HFrEF, heart failure with reduced ejection fraction; HHF, heart failure hospitalization; KCCQ, Kansas City Cardiomyopathy Questionnaire; LV, left ventricle; MRA, mineralocorticoid receptor antagonist; NT-proBNP, N-terminal pro B type natriuretic peptide; NYHA, New York Heart Association; sGC, soluble guanylate cyclase; SGLT2, sodium-glucose co-transporter 2 inhibitor; UACR, urine albumin-creatinine ratio; VO2, oxygen consumption; 6MWD, 6-minute working distance.