A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ej… (NCT06215911) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)
United States557 participantsStarted 2024-02-13
Plain-language summary
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with reduced ejection fraction.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Change in biomarkers from Baseline to Week 12 - NT-proBNP by treatment group