Phase 2
Completed N=789
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
Chronic Heart Failure With Preserved Ejection Fraction
Source: ClinicalTrials.gov NCT03547583 ↗
Enrolled (actual)
789
Serious AEs
18.8%
Results posted
Dec 2020
Primary outcomePrimary: Change in KCCQ Physical Limitation Score From Baseline to Week 24 — 6.41; 5.47; 6.93 Scores on a scale — p== 0.8008
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in KCCQ Physical Limitation Score From Baseline to Week 24 |
6.41; 5.47; 6.93 | = 0.8008 |
| SECONDARY Change in the Six-minute Walk Test (6MWT) From Baseline to Week 24 |
8.68; 5.00; 10.49 | = 0.8054 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Clinical instability at randomization, defined by
- Any IV treatment within 24h prior to randomization, and/or
- SBP ≥160 mmHg
- SBP 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
Data sourced from ClinicalTrials.gov (NCT03547583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.