Heart Failure With Preserved Ejection Fraction
Conditions
Brief summary
This was a multicenter, randomized, double-blind, placebo-parallel-controlled Phase II clinical study to evaluate the efficacy and safety of HRS9531 Injection compared to placebo in obese subjects with heart failure with preserved ejection fraction. A total of 200 obese subjects with heart failure with preserved ejection fraction would be enrolled. Eligible subjects were randomly assigned to either HRS9531 group or placebo group and were treated with HRS9531 injection or placebo, respectively, for 52 weeks.
Interventions
DRUGHRS9531
subcutaneous
DRUGPlacebo
subcutaneous
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, age above or equal to 18 years at the time of signing informed consent. 2. Body mass index (BMI) greater than or equal to 28.0 kg/m\^2 3. New York Heart Association (NYHA) Class II-IV; 4. Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening
Exclusion criteria
1. Medical history of myocardial infarction, acute decompensated heart failure, heart failure requiring hospitalization or urgent heart failure visit, unstable angina, stroke, or transient ischemic attack within 30 days prior to or at screening; 2. Haemoglobin A1c (HbA1c) greater than or equal to 11.0% at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score | From baseline (week 0) to week 36 |
| Change in body weight | From baseline (week 0) to week 36 |
Secondary
| Measure | Time frame |
|---|---|
| Hierarchical composite of time to the first heart failure events requiring hospitalisation or urgent heart failure visit | From baseline (week 0) to week 36,52 |
| Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 36, 52 weeks | From baseline (week 0) to week 36,52 |
| Change in KCCQ clinical summary score | From baseline (week 0) to week 52 |
| Hierarchical composite of time to all-cause death | From baseline (week 0) to week 36,52 |
| Change in C-Reactive Protein (CRP) | From baseline (week 0) to week 36,52 |
| Change in N-terminal pro-b-type natriuretic peptide (NT-proBNP) | From baseline (week 0) to week 36,52 |
| Change in body weight | From baseline (week 0) to week 52 |
| Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit | From baseline (week 0) to week 36,52 |
Countries
China
Outcome results
None listed