Heart failure is a significant public health concern in the United States, with prevalence increasing year to year. It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we are previewing six Phase 3 clinical trials on heart failure that we anticipated will conclude later this year. The following clinical trials feature a range of start dates, with the earliest being November 2017. Currently, all six trials have estimated primary completion dates for 2026. Visit the source pages, linked in the overview section, for the most up-to-date timeframe estimations.

Phase 3 Heart Failure Trials Expected to Complete in 2026
Study TitleEstimated EnrollmentStart DatePrimary Completion Date (anticipated)
Tailored Exercise Training Study Among Adults With HFpEF (TEXPEF)120February 2025December 2026
Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT)2000November 2017December 2026
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)230January 2024October 2026
A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation (ATHENA)680April 2024October 2026
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION)1500July 2024July 2026
A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF)5200January 2024April 2026
Overview of Heart Failure Clinical Trials Anticipated to Complete This Year

Tailored Exercise Training Study Among Adults With HFpEF (TEXPEF)

  • Sponsor: University of Texas Southwestern Medical Center
  • Goal: This study will investigate the effects of a remote exercise training intervention on exercise capacity and skeletal muscle composition in patients with heart failure with preserved ejection fraction or those at risk for it. In addition, it will compare four different lifestyle interventions for their effects on exercise capacity.
    Interventions: Moderate-intensity continuous training (MCT), resistance training, weight loss
  • Primary Outcome Measures: Peak exercise oxygen update (VO2peak); Short physical performance battery (SPPB).
  • Time Frames: Baseline three months, six months, and nine months; Baseline three months, six months, and nine months.
  • Study Details
  • Source

Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction (SPIRRIT)

  • Sponsor: Uppsala University
  • Goal: SPIRRIT is a unique registry-randomized clinical trial that will test the hypothesis that spironolactone plus standard of care compared to standard of care alone reduces the composite of CV mortality and HF hospitalization.
  • Interventions: Spironolactone, standard care
  • Primary Outcome Measure: Incidence rate for total heart failure (HF) hospitalizations or cardiovascular (CV) death
  • Time Frame: Collected at data base lock, five years after study start (US: continuously until five years after study start)
  • Study Details
  • Source

LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (LEVEL)

  • Sponsor: Tenax Therapeutics
  • Goal: This study will evaluate the efficacy of TNX-103 (oral levosimendan) compared with placebo in subjects with PH-HFpEF as measured by the change in 6-Minute Walk Distance (6 MWD; Day 1 to Week 12).
  • Interventions: TNX-103, placebo
  • Primary Outcome Measure: Change in six-minute walk distance
  • Time Frame: 12 weeks
  • Study Details
  • Source

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation (ATHENA)

  • Sponsor: Novo Nordisk A/S
  • Goal: The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation.
    Interventions: Ziltivekimab, placebo
  • Primary Outcome Measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS)
  • Time Frame: From randomisation (month 0) to end-of-treatment (month 12)
  • Study Details
  • Source

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) (CONFIRMATION)

  • Sponsor: Colorado Prevention Center
  • Goal: Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.
  • Interventions: Finerenone, empagliflozin
  • Primary Outcome Measures: Clinical benefit; Number of serious adverse events (AEs); Number of adverse events leading to discontinuation of study drug.
  • Time Frames: Six months; six months; six months.
  • Study Details
  • Source

A Study to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF)

  • Sponsor: Colorado Prevention Center
  • Goal: Finerenone will be compared to placebo to determine efficacy and safety of treatment in patients hospitalized with acute decompensated heart failure (HF) and mildly reduced or preserved left ventricular ejection fraction.
  • Interventions: Finerenone, placebo
  • Primary Outcome Measures: Composite total of HF events and cardiovascular (CV) death; Number of serious adverse events; Number of adverse events leading to discontinuation of study drug.
  • Time Frames: Ongoing, up to ~30 months; Ongoing, up to ~30 months; Ongoing, up to ~30 months.
  • Study Details
  • Source

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