Obese with heart failure with preserved ejection fraction
Conditions
Interventions
Experiment group:HRS9531 Injection
Control group:HRS9531 injection placebo
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Voluntary signing of informed consent to participate in this study ; 2.Age >= 18 years old, male or female ; 3.Chronic heart failure was diagnosed at least 3 months before screening, and heart failure with preserved ejection fraction was diagnosed according to the Chinese expert consensus on diagnosis and treatment of heart failure with preserved ejection fraction 2023 ' during the screening period. 4.During the screening period and the first day, the New York Heart Association ( NYHA ) cardiac function grade II-IV was randomly pre-selected. 5.Pre-randomized body mass index ( BMI ) >= 28 kg / m^2 during the screening period and day 1. 6.Diet and exercise were controlled for 3 months or more before screening, and the weight change was less than 5 kg within 3 months before screening and randomization. 7.The total clinical score of the Kansas City Cardiomyopathy Questionnaire ( KCCQ-CSS ) =4 weeks ; 9.Able to and willing to comply with the provisions of the program to complete the test related records;
Exclusion criteria
Exclusion criteria: 1.Patients with myocardial infarction, acute heart failure and other related cardiovascular and cerebrovascular diseases within 30 days before screening ; 2.Screening for previous 3 months or planned coronary revascularization ( percutaneous coronary intervention ( PCI ) or coronary artery bypass grafting ( CABG ) ), atrial flutter / fibrillation ablation, valve repair / replacement, carotid or peripheral artery recanalization ; 3.Implantation of cardioverter defibrillator ( ICD ) or internal electrocardiogram within 1 year before screening indicated persistent abnormal discharge. 4.Receive cardiac resynchronization therapy ( CRT ) or implant any left ventricular assist device ; 5.Heart failure due to other causes ; 6.Dyspnea caused by other diseases ; 7.There are endocrine diseases or medical history that may significantly affect body weight. 8.Have any previous conditions that affect gastric emptying or have undergone gastrointestinal surgery; 9.Screening for acute pancreatitis or previous history of chronic pancreatitis within 6 months before screening. 10.Patients with chronic malabsorption syndrome or cholestasis in the past; 11.Previous or known history of medullary thyroid carcinoma ( MTC ) or multiple endocrine neoplasia type 2 ( MEN2 ) or family history ; 12.Severe infection or severe trauma or received large and medium-sized surgery one month before screening ; 13.Any organ system malignant tumor occurred within 5 years ; 14.There are serious mental illness ; 15.There was a history of alcohol abuse and / or drug abuse or drug abuse within 1 year before screening ; 16.Previously diagnosed or suspected type 1 or other type of diabetes ; 17.Severe hypoglycemia events or recurrent hypoglycemia events occurred within 3 months before screening. 18.Acute complications of diabetes occurred within 3 months before screening. 19.Screening for proliferative retinopathy or macular lesions, painful diabetic neuropathy, diabetic foot ulcers, and intermittent claudication requiring acute treatment ; 20.Abnormal laboratory test values in the screening period have clinical significance ; 21.Combined with infectious diseases ; 22.Patient health questionnaire-9 ( PHQ-9 ) score >=15 ; 23.Weight loss related drugs or treatments were used in the first 3 months of screening ; 24.Those who are allergic to GLP-1 and / or GIP receptor agonist drugs and their excipients ; 25.Participated in clinical trials of any drug or medical device within 3 months before screening ; 26.To plan surgery during the trial period ; 27.Subjects with mental incapacity or language barriers cannot fully understand or participate in the test process ; 28.Pregnant or lactating women, or during the trial and within 2 months after the last administration could not take effective contraceptive measures; 29.The investigators determined that there were other circumstances that affected the safety of the subjects or any other interference with the evaluation of the results of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The changes of KCCQ-CSS relative to baseline at the 36 th week after the first administration ;Percentage change in body weight relative to baseline at 36 weeks after first administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| The endpoint of the composite event of heart failure at 36 and 52 weeks after the first administration ( the time to all-cause death, the number of events due to heart failure hospitalization or emerg; | — |
Countries
China
Contacts
Public ContactChangsheng Ma
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed