Heart failure preserved with ejection fraction
Conditions
Sponsors
Shanghai University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. When signing the informed consent, the subjects must be 40 years old and above; 2. Patients diagnosed with heart failure, NYHA II-III, mainly due to outpatient consultation or hospitalization of heart failure; 3. LVEF >= 50% measured in any form within the past 12 months (at the latest at screening); if there are multiple values, the most recent value should be reported. If LVEF has not been measured in the past 12 months, a new measurement will be required during the screening period; 4. Structural cardiac abnormalities based on any local imaging measurements (last screening) within the past 12 months, defined as at least one of the following: o LAD >= 3.8 cm, LAVI > 30 mL/m2, LVMI >=115 g/m2 (?)/95 g/m2 (?), thickness of spacer or back wall >=1.1 cm, E/e'>=13; 5. NT-proBNP>=125ng/L (BNP>=35ng/L).
Exclusion criteria
Exclusion criteria: 1. At the screening visit, eGFR5.0 mmol/L at the screening visit; 3. Acute inflammatory heart disease occurred within 60 days before enrollment; 4. Myocardial infarction or any event that may reduce ejection fraction within 60 days before enrollment; 5. Coronary artery bypass grafting was performed 90 days before enrollment; 6. Stroke or transient ischemic attack occurred within 30 days before enrollment; 7. The investigator believes that the subject's HF symptoms may be caused by other reasons, such as the patient's symptoms of dyspnea may be due to severe lung disease, anemia or obesity; 8. 2 consecutive measurements at least 2 minutes apart at screening or randomization, systolic blood pressure (SBP) >= 160 mmHg and no treatment with >= 3 antihypertensive drugs or >= 180 mmHg (regardless of treatment); 9. Life-threatening or uncontrollable arrhythmias at screening, including but not limited to: sustained ventricular tachycardia, or atrial flutter with resting ventricular rate >110 bpm; 10. Symptomatic hypotension (mean systolic blood pressure <90 mmHg) at screening; 11. Left ventricular assist device at screening; 12. Pregnant or lactating (lactating) women, where pregnancy is defined as the state after a woman has conceived until the termination of pregnancy, and confirmed positive urine or serum test results for human chorionic gonadotropin; 13. Hepatic insufficiency classified as Child-Pugh C at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walking test;cardiopulmonary exercise test;NT-ProBNP;brain natriuretic peptide;cardiac color Doppler examination;eukaryotic reference transcriptome sequencing;targeted metabolomic detection; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minnesota quality of life scale for cardiac insufficiency;Kansas City Cardiomyopathy Questionnaire;total efficacy assessment; | — |
Countries
China
Contacts
Public ContactXiao Junjie
Shanghai University
Outcome results
None listed