A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)

Launched by CARDURION PHARMACEUTICALS, INC. · Jan 19, 2024

Keywords

ClinConnect Summary

This clinical trial, called Cycle-1-REF, is studying a new medication called tovinontrine to see if it can safely and effectively lower a specific marker in the blood called NT-proBNP in patients with chronic heart failure, particularly those with reduced heart function (ejection fraction of 40% or less). The trial aims to understand how well this medication works compared to a placebo, which is a treatment that doesn't contain any active medicine.

To be eligible for the trial, participants must be adults aged 18 or older who have been diagnosed with heart failure for at least six months and have certain symptoms or medical history related to heart failure. They should also be stable on their current heart failure medications for at least four weeks. If you join this study, you will have regular check-ups and tests to monitor your health and response to the treatment. It's important to note that if you have had recent heart issues or specific heart procedures, you might not qualify for this trial. This study is currently looking for participants, so if you or someone you know might be interested, please consider discussing it with a healthcare provider.

Gender

ALL

Eligibility 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.