Actively Recruiting
Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-12-29
225
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled, parallel design phase II clinical trial, including a screening period of up to 2 weeks, a 36-weeks' treatment period, and a 1-week safety follow-up visit period.
CONDITIONS
Official Title
Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 80 years on the day of signing informed consent
- Diagnosed with chronic heart failure for at least 1 month before screening and confirmed heart failure with preserved ejection fraction during screening
- New York Heart Association (NYHA) functional classification II to IV during screening and on day 1 before randomization
- Body mass index (BMI) of 28 kg/m2 or higher during screening and on day 1 before randomization
- Self-reported controlled diet and exercise for 3 months or more before screening with weight change of no more than 5kg in that time
- Kansas City Cardiomyopathy Questionnaire clinical score (KCCQ-CSS) of 80 points or less during screening and on day 1 before randomization
- Able to walk 100 to 425 meters in two 6-minute walk tests during screening
- Stable dose of medication for underlying diseases (excluding oral diuretics) for at least 4 weeks before screening
- Capable and willing to comply with study requirements, understand the trial and possible side effects, and complete required questionnaires
You will not qualify if you...
- History of myocardial infarction, acute decompensated heart failure, hospitalization or emergency treatment due to heart failure, unstable angina, stroke, or transient ischemic attack within 30 days before or during screening
- Laboratory abnormalities with clinical significance such as persistent sinus tachycardia on ECG during screening or on day 1 before randomization
- Use of drugs or treatments causing significant weight change within the past 3 months before screening
- Any medical, psychological, social, or geographical conditions that may affect safety or study evaluation as judged by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
J
Junmeng Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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