Heart Failure with Preserved Ejection Fraction
Conditions
Interventions
Experimental group 1:Neucardin 0.8µg/kg/day, subcutaneous drip for 8 hours a day, for 10 consecutive days.
Experimental group 2:Neucardin 0.27µg/kg/time, subcutaneous injection, 3 times a day, 4 hours apart, for 10 consecutive days.
Control group 1:Placebo,subcutaneous drip for 8 hours a day, for 10 consecutive days.
Control group 2:Placebo, subcutaneous injection, 3 times a day, 4 hours apart, for 10 consecutive days.
Sponsors
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Above 18 years old, male or female; 2. The left ventricular ejection fraction (LVEF)>= 50%. Except for subjects with initially diagnosed HFpEF, LVEF results must not be less than 40% in the past 6 months; 3. NYHA II-III class, be in stable condition and no need for intravenous vasoactive drugs or intravenous diuretics; 4. NT-proBNP >= 220pg/mL (sinus rhythm) or NT-proBNP >= 660pg/mL (atrial fibrillation); 5. Left ventricular diastolic dysfunction (echocardiography): E/e >= 10 and average e (ventricular septum and free wall / left ventricular lateral wall) = 1.0 in the cardiopulmonary exercise test, the Peak VO2 was < 84% or < 20ml/min/kg; 7. Understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Hypertrophic cardiomyopathy with left ventricular outflow tract obstruction, constrictive pericarditis, obvious and uncorrected valvular heart disease (severe degenerative disease or severe stenosis or valvular disease requiring surgery), congenital heart disease that requires surgery but has not been treated surgically, primary pulmonary hypertension or secondary severe pulmonary hypertension; 2. Transient ischemic attack of acute coronary syndrome occurred in the last 3 months; 3. Patients with cardiac surgery, CRT or other implanted devices of left ventricular auxiliary device or cerebrovascular accident in the past 6 months; 4. Patients who are ready for heart transplantation, CRT or left ventricular assist devices or other implantable devices; 5. Patients with acute heart failure with hemodynamic disorder within 1 month; 6. Severe ventricular arrhythmia, second degree type II and third degree atrioventricular block or sick sinus syndrome; 7. Diagnosis of perinatal or chemotherapy-induced cardiomyopathy within the last 12 months; 8. Patients requiring mechanical ventilation and cardiac mechanical assistance; 9. SBP > 140 mmHg or DBP > 90 mmHg, or used intravenous antihypertensive drugs in the last 1 month; 10. Severe aortarctia or aortic valve stenosis; 11. B-mode ultrasound shows pericardial effusion (> 50ml or 3mm) or pleural effusion (> 200ml or 10mm); 12. Patients with hepatic or renal dysfunction or chronic liver disease that may have potential effects on liver function, non-heart failure cause bilirubin or alkaline phosphatase > 2 times the normal upper limit, AST or ALT > 3 times the normal upper limit, or the eGFR 5.5 mmol/L; 14. Women or men of childbearing age who have a pregnancy plan within 2 years (childbearing age is defined as all women or men with physical ability to become pregnant), women who are pregnant or breastfeeding; 15. Subject with a life expectancy less than 6 months as assessed by the investigator; 16. Patients who participated in any clinical trial in the recent three months; 17. Serious nervous system diseases (Alzheimer's disease, advanced Parkinsonism), lower limb defects, or deaf-mute. 18. History of any malignancy or suffering from cancer, or biopsy proven pre-malignant condition (e.g., DICS or cervical atypia); 19. Evidence (physical examination, chest X-ray, B-ultrasonography or other tests) shows some active malignancy or adenoidal hypertrophy or neoplasm that has an effect on heart function or the endocrine system, e.g., pheochromocytoma or hyperthyroidism (Thyroid nodules with normal thyroid function do not need to be excluded). 20. As judged by the investigator that the subject cannot complete the study or adhere to the study requirements (due to the management reasons or others).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Peak VO2 from baseline at day 30 by Cardiopulmonary Exercise Testing.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Peak VO2 from baseline at day 90 by Cardiopulmonary Exercise Testing.;Changes in Peak VO2 %pred , AT, OUEP, Lowest VE/VCO2, VE / VCO2 slopes, Peak O2 Pulse, SBP/DBP, heart rate and power from baseline at day 30 and day 90 by Cardiopulmonary Exercise Testing.;Changes in echocardiographic parameters from baseline.;Changes in LVEF from baseline.;Changes in NYHA class from baseline.;Changes in NT-proBNP from baseline.; | — |
Countries
China
Contacts
Public ContactYang Xinchun
Affiliated Beijing Chaoyang Hospital of Capital Medical University
Outcome results
None listed