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Assessing Tovinontrine for Chronic Heart Failure with Reduced Ejection Fraction

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Phase 2 Interventional Cardurion Pharmaceuticals, Inc. · NCT06215911

This study is testing if a new heart medication called tovinontrine can help people with chronic heart failure feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorCardurion Pharmaceuticals, Inc. Industry-sponsored
Locations128 sites (Birmingham, Alabama and 127 other locations)
Trial IDNCT06215911 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of tovinontrine, a PDE9 inhibitor, in patients with chronic heart failure and reduced ejection fraction. Participants will receive either tovinontrine or a placebo, and the primary outcome will be the reduction of NT-proBNP levels, a marker of heart failure severity. The study aims to determine if tovinontrine can provide significant benefits over placebo in managing heart failure symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic heart failure symptoms and an ejection fraction of 40% or less.

Not a fit: Patients with heart failure not meeting the specified criteria or those with atrial fibrillation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve heart failure management and patient quality of life.

How similar studies have performed: Other studies have explored PDE9 inhibitors in heart failure, but the specific approach of tovinontrine is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Is an adult male or female patient 18 years of age
* Has evidence in the medical history supporting a diagnosis of clinical HF syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening. The HF syndrome is defined by documentation of 1 or more of the following:

  * At least 1 of the typical symptoms due to HF such as dyspnea and/or fatigue limiting exercise capacity;
  * At least 1 of the typical signs of HF such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or
  * Hospitalization, emergency department visit, or outpatient visit for HF requiring intravenous (IV) or subcutaneous (SQ) diuresis within the past 12 months.
* Has ejection fraction (EF) ≤ 40% by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;
* Has NT-proBNP level ≥ 600 pg/mL at the time of Screening. Patients with atrial fibrillation or flutter at the time of Screening are required to have an NT-proBNP level of ≥ 1000 pg/mL at the time of Screening;
* Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgement, for a minimum of 4 weeks prior to the time of Screening and during Screening, with no planned changes after randomization.
* Has had no addition of new guideline-directed HF therapy within the 3 months prior to the time of Screening or during the Screening Period;

Exclusion Criteria:

* Has a documented EF \>40% by TTE within 6 months of the time of Screening or during the Screening Period;
* Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 60 days of the time of Screening or during the Screening Period;
* Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration;
* Has elective interventions (eg, percutaneous coronary intervention, device implantations, percutaneous structural heart disease interventions, cardiac and non-cardiac surgery) planned to occur during involvement in this study;
* Has acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, or carotid angioplasty within 60 days of the time of Screening or during the Screening Period;
* Has had a prior or planned orthotopic heart transplantation;
* Has presence of or plan for mechanical circulatory support;

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Birmingham, Alabama and 127 other locations

+78 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureHeart Failure With Reduced Ejection FractionCardiovascular DiseasesHeart DiseasesPDE9PED9 InhibitorCRD-750Tovinontrine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.