Heart Failure With Preserved Ejection Fraction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. male or female aged >= 60 years old, 2. informed consent gave. 3. No initiation or cessation of any following drugs during the past 30-day regimenACEIARBß-receptor blockerCCB and Aldosterone antagonist. The Dosage adjustment of mentioned drugs does not exceed 100%. 4. Symptoms and signs of chronic heart failure (NYHA class II -IV). 5. Heart failure is the major factor of activity limitation. 6. LVEF >= 50%. 7. No continuous nitrate medication in the past 3 months or infrequent (less than once a week) intermittent sublingual administration of nitroglycerin. 8. Any occurance of the following situations in the past 12 months. (1). BNP > 200 pg/ml or NT-proBNP> 400 pg/ml. (2). Hospitalization for HF in the pastwith Imaging findings of pulmonary congestion. (pulmonary venous hypertension, vascular blockage, interstitial edema, pleural effusion). (3). LVEDP>= 15mmHg or PCWP>= 20mmHg at rest, or PCWP > 25mmHg during exercise. (4). Echocardiographic indications of diastolic dysfunction or increased filling pressure, with at least two of the following diagnostic criteria: (4-1) E/A > 1.5 or the E/A reduced > 0.5 during Valsalva Maneuver. (4-2) Peak deceleration time = 15. (4-4) Moderate left atrial enlargement. (4-5) Pulmonary artery systolic blood pressure > 40 mmHg. (4-6) left ventricular hypertrophy. (5) LV mass/BSA >= 96g/m2 (female) or >= 116g/m2 (male). (6) Relative wall thickness >= 0.43mm. (7) Left ventricular posterior wall thickness >= 0.9cm (female) or 1.0 cm (male). 9. unrelying on wheelchairs, flat cars, wheeled walkers or crutches.
Exclusion criteria
Exclusion criteria: 1. Incooperation with the study out of any reason or the investigator considers it inappropriate if included; 2. Any of the following past medical history: Hospitalization for HF during the past 3 months; Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery, or percutaneous coronary; intervention (PCI) during the past 3 months; Primary hypertrophic cardiomyopathy; infiltrative cardiomyopathy(amyloidosis); Constrictive pericarditis or pericardial tamponade; Active myocarditis; Complex congenital heart disease; Active vascular disease; Mild to severe aortic or mitral stenosis; Moderate to severe valvular disease (prolapse, rheumatism) or severe mitral, tricuspid, or aortic regurgitation; Severe acute or chronic hepatic disease as determined by any one of the following: hepatic encephalopathy, varicose veins, bleeding, INR > 1.7 without anticoagulant therapy. 3. Any of the following symptoms or signs: (1) Severe COPD or dyspnea caused by ischemia; (2) Blood pressure and heart rate match one of the following: (2-1): Systolic blood pressure > 180 mmHg or 100 mmHg; (2-3): Resting heart rate > 110 bpm 4. The laboratory examination conforms to any of the following: (4-1): Hemoglobin (Hgb) < 8.0 g/dl; (4-2): Chronic Kidney Disease with GFR< 20 ml/min/1.73 m2. 5. Any prior echocardiographic measurement of LVEF value < 45%; 6. Any Comorbidity with a life expectancy < 1 year; 7. Enrolled or planned to enroll in other therapeutic clinical trials in the next three months; 8. Non- adherence to medical regimens.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ß-OHB;IL1ß;IL18;TNF-a;OCR;ECAR; | — |
Countries
China
Contacts
Sichuan University West China Hospital