Heart Failure Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

400

Study ID:

NCT06215911

Recruitment Status:

Recruiting

Sponsor:

Cardurion Pharmaceuticals, Inc.

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There are 9 Locations for this study

See Locations Near You

Cardurion Investigative Site
Little Rock Arkansas, 72204, United States
Cardurion Investigative Site
Beverly Hills California, 90211, United States
Cardurion Investigative Site
Van Nuys California, 91405, United States
Cardurion Investigative Site
Jacksonville Florida, 32216, United States
Cardurion Investigative Site
Miami Florida, 33137, United States
Cardurion Investigative Site
Hazel Crest Illinois, 60429, United States
Cardurion Investigative Site
Peoria Illinois, 61636, United States
Cardurion Investigative Site
Covington Louisiana, 70433, United States
Cardurion Investigative Site
McKinney Texas, 75069, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

400

Study ID:

NCT06215911

Recruitment Status:

Recruiting

Sponsor:


Cardurion Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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