Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Heart Failure With Preserved Ejection Fraction

In brief

The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.

Key facts

Study ID

NCT03547583

Run by

Bayer

People needed

789

Starts

2018-06-15

Expected to finish

2019-11-04

Last updated by the study team

2021-01-06

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Previous diagnosis of chronic heart failure (HF)
• HF decompensation within 6 months prior to randomization, defined as hospitalization for HF or intravenous (IV) diuretic treatment for HF without hospitalization.
• N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP
• ≥600 or BNP ≥200 pg/mL in atrial fibrillation within 30 days prior to randomization
• Diagnostic criteria of HFpEF by echocardiography assessed within 12 months prior to randomization (most recent measurement must be used to determine eligibility with no interim event signaling potential deterioration in ejection fraction)
• Left ventricular ejection fraction (LVEF) ≥45% and
• Structural changes indicated by at least one of the following parameters:
• Left ventricle (LV) hypertrophy (any of the following: intraventricular septal or posterior wall thickness ≥1.1 cm, and/or LV mass index ≥115 g/m*2 in male and ≥95 g/m*2 in female), or
• Left atrium (LA) enlargement (any of the following: left atrial volume (LAV) index ≥29 ml/m*2, or LAV >58 mL in male and >52 mL in female patients, or LA area >20 cm*2, or LA diameter >40 mm in male and >38 mm in female patients)
• NYHA class II or III at randomization

You may not qualify if…

• Clinical instability at randomization, defined by
• Any IV treatment within 24h prior to randomization, and/or
• SBP ≥160 mmHg
• SBP <110 mmHg and/or DBP <40 mmHg and/or symptomatic hypotension
• Resting heart rate (HR) <50 or ≥100 beats per minute (bpm)
• Use of IV inotropes at any time between qualifying HF event and randomization
• Previous diagnosis of reduced ejection fraction (EF) (EF <40%)
• Hypertrophic obstructive cardiomyopathy, acute myocarditis, amyloidosis, sarcoidosis, or pericardial disease
• Primary valvular heart disease requiring surgery or intervention, or within 3 months after valvular surgery or intervention, or active endocarditis
• Acute coronary syndrome, including unstable angina, Non ST-elevation myocardial infarction or ST-elevation myocardial infarction, or Coronary artery bypass grafting (CABG) within 60 days prior to randomization, or indication for Percutaneous coronary intervention or CABG at the time of randomization
• Symptomatic carotid stenosis, or transient ischemic attack or stroke within 60 days prior to randomization
• Complex congenital heart disease
• Non-cardiac comorbidity (any of the following)
• Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73 m*2 calculated by Modification of Diet in Renal Disease formula
• Hepatic insufficiency classified as Child-Pugh B or C
• Morbid obesity with a body mass index >45 kg/m*2
• Malignancy or other non-cardiac condition limiting life expectancy to <1 year, per physician judgment
• Requires continuous home oxygen for severe pulmonary disease or has interstitial lung disease
• Patients with allergies, intolerance or hypersensitivity to investigational drug or any of the excipients
• Concurrent or anticipated use of nitrates or NO donors, phosphodiesterase type V (PDE5) inhibitors, or a Soluble guanylate cyclase (sGC) stimulator

Where it is running

• Capitol Interventional Cardiology — Carmichael, California, United States
• Interventional Cardiology Medical Group — West Hills, California, United States
• Penrose-St. Francis Health Services — Colorado Springs, Colorado, United States
• Cardiology Associates of Fairfield County, PC — Trumbull, Connecticut, United States
• Cardiology Associates Of South Florida PA — Boynton Beach, Florida, United States
• Cardiovascular and Vein Center of Florida — Bradenton, Florida, United States
• Cardiology Associates Research Company — Daytona Beach, Florida, United States
• LifeSpring Research Foundation, LLC — Miami, Florida, United States
• Southwest Florida Research — Naples, Florida, United States
• East Coast Institute for Research, LLC — Saint Augustine, Florida, United States
• Cardiology Partners — Wellington, Florida, United States
• Fox Valley Clinical Research Center, LLC — Aurora, Illinois, United States
• Advocate Condell Medical Center — Libertyville, Illinois, United States
• Reid Health — Richmond, Indiana, United States
• Research Integrity, LLC — Owensboro, Kentucky, United States
• Heart Clinic of Hammond — Hammond, Louisiana, United States
• Anne Arundel Health System — Annapolis, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Riser Medical Associates — Picayune, Mississippi, United States
• St. Louis Heart & Vascular, PC — St Louis, Missouri, United States
• Glacier View Research Institute — Kalispell, Montana, United States
• Bryan Heart — Lincoln, Nebraska, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Capital Area Research, LLC — Camp Hill, Pennsylvania, United States
• WestSide Medical — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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