Active — Not RecruitingNot Applicable

RESPONDER-HF Trial

United States750 participantsStarted 2022-11-17

Plain-language summary

Multicenter, Prospective, Randomized, Sham Controlled, Double Blinded Clinical Trial, with; 1:1 randomization

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Chronic symptomatic heart failure (HF) documented by the following:
✓. Symptoms of HF requiring current treatment with diuretics if tolerated for ≥ 30 days AND
✓. New York Heart Association (NYHA) class II; OR NYHA class III, or ambulatory NYHA class IV symptoms; AND
✓. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) diuretics; or intensification of oral diuresis within the 12 months prior to study entry; OR an NT-proB-type Natriuretic Peptide (NT-pro BNP) value \> 150 pg/ml in normal sinus rhythm, \> 450 pg/ml in atrial fibrillation, or a brain natriuretic peptide (BNP) value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months
✓. Ongoing stable guideline-directed medical therapy (GDMT) HF management and management of comorbidities according to the 2022 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Heart Failure. Stable management includes a minimum period of 4 weeks post-hospitalization for any cause, including treatment with IV diuretics
✓. Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction \< 30% in the 5 years prior.
✓. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
✓. Left Atrial (LA) diameter \> 4 cm; or

✕. Advanced heart failure defined as one or more of the below:
✕. ACC/AHA/European Society of Cardiology (ESC) Stage D heart failure, non-ambulatory NYHA Class IV HF
✕. Cardiac index \< 2.0 L/min/m2
✕. Inotropic infusion (continuous or intermittent) for EF \< 40% within the past 6 months
✕. Patient is on the cardiac transplant waiting list.
✕. Inability to perform 6-minute walk test (distance \< 50 meters), OR 6-minute walk test \> 600m
✕. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle (and not by shortness of breath and/or fatigue and/or chest pain)
✕. Right ventricular dysfunction, assessed by the site cardiologist and defined as one or more of the following:

Composite Primary Endpoint

Timeframe: Up to 12 months

NCT IDNCT05425459

SponsorCorvia Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Chronic symptomatic heart failure (HF) documented by the following:
✓. Symptoms of HF requiring current treatment with diuretics if tolerated for ≥ 30 days AND
✓. New York Heart Association (NYHA) class II; OR NYHA class III, or ambulatory NYHA class IV symptoms; AND
✓. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) diuretics; or intensification of oral diuresis within the 12 months prior to study entry; OR an NT-proB-type Natriuretic Peptide (NT-pro BNP) value \> 150 pg/ml in normal sinus rhythm, \> 450 pg/ml in atrial fibrillation, or a brain natriuretic peptide (BNP) value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months
✓. Ongoing stable guideline-directed medical therapy (GDMT) HF management and management of comorbidities according to the 2022 American College of Cardiology (ACC)/American Heart Association (AHA) Guidelines for the Management of Heart Failure. Stable management includes a minimum period of 4 weeks post-hospitalization for any cause, including treatment with IV diuretics
✓. Site determined echocardiographic LV ejection fraction ≥ 40% within the past 6 months, without documented ejection fraction \< 30% in the 5 years prior.
✓. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
✓. Left Atrial (LA) diameter \> 4 cm; or

✕. Advanced heart failure defined as one or more of the below:
✕. ACC/AHA/European Society of Cardiology (ESC) Stage D heart failure, non-ambulatory NYHA Class IV HF
✕. Cardiac index \< 2.0 L/min/m2
✕. Inotropic infusion (continuous or intermittent) for EF \< 40% within the past 6 months
✕. Patient is on the cardiac transplant waiting list.
✕. Inability to perform 6-minute walk test (distance \< 50 meters), OR 6-minute walk test \> 600m
✕. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle (and not by shortness of breath and/or fatigue and/or chest pain)
✕. Right ventricular dysfunction, assessed by the site cardiologist and defined as one or more of the following: