Heart Failure with Preserved Ejection Fraction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1, Age = 60 years old 2, Signed informed consent 3, No new initiation or discontinuation of any of the following drugs in the previous 30-day regimen: ACEI, ARB, ß-blocker, CCB, and aldosterone antagonist. And no more than 100% dose adjustment of the above medications. 4. Symptoms of dyspnea (NYHA class II-IV) are present and the symptoms of dyspnea cannot be explained by non-cardiac or ischemic evidence 5. HF is the primary factor limiting activity 6. EF =50% as determined by imaging and current clinical status showing no potential for deterioration of systolic function 7, No continuous nitrate therapy or infrequent (less than 1 time/week) intermittent sublingual nitroglycerin administration in the past 3 months 8, One of the following conditions in the past 12 months: (1) NT-proBNP> 400 pg/ml or BNP> 200 pg/ml. (2) Past admission for HF with imaging evidence of pulmonary hemorrhage (pulmonary hypertension, vascular obstruction, interstitial edema, pleural effusion). (3) LVEDP =15 mmHg or PCWP =20 mmHg at rest or PCWP =25 mmHg during exercise measured by catheterization. (4) Ultrasound evidence of diastolic limitation or increased filling pressures, with at least two of the following diagnostic criteria: 4-1: E/A > 1.5 or a decrease in E/A > 0.5 during Valsalva maneuvers 4-2: Peak deceleration time = 140 ms. 4-3: Systolic pulmonary venous flow rate less than diastolic (PVs 40 mmHg 4-6: Evidence of left ventricular hypertrophy (5) LV mass/BSA = 96 in women or = 116 g/m2 in men (6) Relative ventricular wall thickness = 0.43 (7) LV posterior wall thickness = 0.9 in women or = 1.0 cm in men 9 Self-mobility without the use of a wheelchair, scooter, wheeled walking frame, or crutches.
Exclusion criteria
Exclusion criteria: 1, Any reason for not being able to cooperate with the study or the investigator thinks it is not suitable to be included in this trial 2, Having any of the following medical history, past history: (1) Hospitalization for HF within the past 3 months. (2) Acute coronary syndrome as determined by ECG changes or markers of myocardial injury (e.g., troponin) within the past three months. (3) PCI, CABG, or biventricular pacing within the past 3 months (4) Primary hypertrophic cardiomyopathy (5) Infiltrative cardiomyopathy (amyloidosis) (6) constrictive pericarditis or pericardial tamponade (7) Active myocarditis (8) Complex congenital heart disease (9) Active vascular disease (10) more than mild aortic or mitral stenosis (11) Moderate to severe valvular disease (prolapse, rheumatic) or severe mitral, tricuspid, or aortic regurgitation (12) Severe acute or chronic liver disease supported by any of the following: hepatic encephalopathy, varicose veins, hemorrhage, INR > 1.7 in the absence of anticoagulation. 3, Any of the following symptoms or signs (1) Severe COPD or ischemia resulting in dyspnea (2) Dyspnea due to ischemia (3) Blood pressure and heart rate meet one of the following: - SBP 180 mmHg - DBP 100 mmHg - Resting heart rate > 110 bpm 4, Laboratory tests meet any of the following: (1) Hemoglobin less than 8.0 g/dl (2) GFR < 20 ml/min/1.73 m2 in the most recent test report. 5, An ejection fraction in the range of less than 45% as determined by imaging. 6, Comorbid terminal disease other than HF with a life expectancy of less than one year 7, Enrollment or planned enrollment in other therapeutic clinical trials in the next three months. 8, Inability to comply with the planned study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCAAs;PP2cm;BCAT1;BCAT2;RNA-seq analysis result;Blood single-cell sequencing analysis result; | — |
Countries
China
Contacts
West China Hospital, Sichuan University