Heart Failure with Preserved Ejection Fraction
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Stable symptomatic heart failure with preserved ejection fraction (diagnosis according to criteria of the European Society of Cardiology: Paulus et al., 2007); 1.1. New York Heart Association (NYHA) II-III; 1.2. Left ventricular ejection fraction (LVEF) >=50%; 1.3. Ratio of early transmitral flow velocity (E) to early diastolic mitral annular velocity (E')(E/E') >=15; 1.4. 8 220 ng/L or BNP >200 ng/L; (2) LVMI >=122g/m2(female) or 149g/m2(male); 2. Age older than 18 years; 3. Written informed consent of the patient.
Exclusion criteria
Exclusion criteria: 1. Non-cardiac causes for heart failure like symptoms: 1.1. Chronic obstructive pulmonary disease (COPD) - Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages >=II; 1.2. Significant renal dysfunction estimated Glomerular Filtration Rate (eGFR) =IIb); 1.4. Musculoskeletal disease that contribute to reduced exercise performance; 1.5. Specific cardiomyopathy and pericardial disease (e.g. amyloidosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericardial disease etc.); 1.6. Haemodynamically significant valvular disorders; 2. Lower limb vein thrombus or lower limb skin ulcer; 3. Significant coronary artery disease (CAD) [current angina pectoris, Canadian Cardiovascular Society (CCS) >=II or positive stress test, myocardial infarction or coronary artery bypass graft within the last 3 months); 4. Any inability or contraindication to participate in an exercise program (e.g. physiological, mental) or supply essential information (e.g. questionnaire); 5. Ineffective control of resting blood pressure (BP >=140/90mmHg or BP >=160/100mmHg with >=3 antihypertensive drugs) or of resting heart rate (HR >=100bpm); 6. Concomitant participation in other interventional clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 minutes walk test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minnesota Living With Heart Failure Questionnaire (quality of life);Cardiac diastolic function;Pressure of pulmonary circulation;Endothelial function;NT-pro BNP;Exhaled nitric oxide level;Length of hospital stay; | — |
Countries
China