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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
789
Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.
Placebo and sham up-titration at weeks 2, 4, and 6
Change in KCCQ Physical Limitation Score From Baseline to Week 24
The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients' heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Time frame: From baseline to Week 24
Change in the Six-minute Walk Test (6MWT) From Baseline to Week 24
6MWT was conducted to test the physical limitations of the patient by assessing the patient's exercise capacity. The distance walked by the patient in 6 minutes was measured.
Time frame: From baseline to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
WestSide Medical
Beverly Hills, California, United States
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
...and 167 more locations