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Evaluating Tovinontrine for Heart Failure with Preserved Ejection Fraction

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

Phase 2 Interventional Cardurion Pharmaceuticals, Inc. · NCT06215586

This study is testing a new heart medication called tovinontrine to see if it can help adults with heart failure feel better by lowering a specific marker of heart failure severity.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorCardurion Pharmaceuticals, Inc. Industry-sponsored
Locations84 sites (Birmingham, Alabama and 83 other locations)
Trial IDNCT06215586 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of tovinontrine, a PDE9 inhibitor, in patients with chronic heart failure and preserved 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 targets adults with specific heart failure symptoms and ejection fraction criteria, ensuring a focused evaluation of the drug's impact on this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic heart failure symptoms and preserved ejection fraction.

Not a fit: Patients with ejection fraction below 40% or those without documented heart failure symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from chronic heart failure with preserved ejection fraction.

How similar studies have performed: While this approach is novel in the context of heart failure with preserved ejection fraction, similar studies targeting heart failure treatments have shown promising results.

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% and left atrial enlargement by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;
* Has NT-proBNP level ≥ 300 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 ≥500 pg/mL at the time of Screening;
* Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgment, for a minimum of 4 weeks prior to the time of Screening and during the Screening Period, 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 documented EF ≥ 60% 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 83 other locations

+34 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 Preserved 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.