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

C

Cardurion Pharmaceuticals

Status and phase

Enrolling
Phase 2

Conditions

Cardiovascular Diseases
Heart Failure With Reduced Ejection Fraction
Heart Failure
Heart Diseases

Treatments

Drug: Tovinontrine (CRD-750)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06215911
CRD-750-201
2023-508736-62 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

400 participants in 4 patient groups, including a placebo group

Tovinontrine (CRD-750) - low dose
Experimental group
Treatment:
Drug: Tovinontrine (CRD-750)
Tovinontrine (CRD-750) - medium dose
Experimental group
Treatment:
Drug: Tovinontrine (CRD-750)
Tovinontrine (CRD-750) - high dose
Experimental group
Treatment:
Drug: Tovinontrine (CRD-750)
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

15

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Central trial contact

Gail Berman

Data sourced from clinicaltrials.gov

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