Assessing Tovinontrine for Chronic Heart Failure with Reduced Ejection Fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Cardurion Investigative Site
  Birmingham, Alabama, United States Recruiting
• Cardurion Investigative Site
  Little Rock, Arkansas, United States Recruiting
• Cardurion Investigative Site
  Beverly Hills, California, United States Recruiting
• Cardurion Investigative Site
  Orange, California, United States Recruiting
• Cardurion Investigative Site
  Torrance, California, United States Recruiting
• Cardurion Investigative Site
  Van Nuys, California, United States Recruiting

+78 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Gail Berman
• Email: Info@cardurion.com
• Phone: 617-863-8088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.