Heart failure with normal ejection fraction
Conditions
Interventions
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >40 years old; 2. The presence of symptoms and/or signs of heart failure to study entry: (1) Symptoms: breathlessness or fatigue or reduced exercise tolerance or Paroxysmal nocturnal dyspnea or Orthopnoea, etc.; (2) Signs: elevated jugular venous pressure or hepatojugular reflux or third heart sound (gallop rhythm) or cardiomegaly or weight gain or peripheral oedema or pulmonary crepitations. 3. LVEF =50%; 4. BNP>35ng/L; 5. At least one of the following conditions to be fulfilled: (1) Cardiac structural alterationsa left atrial volume index (LAVI) >34 mL/m2) or a left ventricular mass index (LVMI) =115 g/m2 for males and =95 g/m2 for females; (2) Diastolic dysfunction: an E/e'=13 and a mean e septal and lateral wall<9 cm/s; 5. Submitted informed consent.
Exclusion criteria
Exclusion criteria: (1) Acute coronary syndrome; (2) Congenital heart diseases, severe valvular heart disease, constrictive pericarditis, hypertrophic cardiomyopathy, restrictive (infiltrative) cardiomyopathy; (3) Coronary artery bypass graft surgery or percutaneous coronary intervention in the past 90 days; (4) Permanent pacemaker, implantable cardioverter-defibrillator (ICD) or implanted left ventricular assist device in the past 90 days; (5) Systolic pressure greater than 160 mmHg or lower than 90mmHg; (6) Chronic pulmonary disease requiring home oxygen, or drug therapy; (7) Stroke in past 90 days; (8) Special treatments should be used for patients with comorbidities such as severe liver or renal failure and malignant tumor which could influence the clinical treatment of ischemic heart failure; (9) Pregnant or breastfeeding women, or women at childbearing age without reliable methods of contraception; (10) Any condition that, in the opinion of the investigator, may prevent the participant from adhering to the trial protocol; (11) Unable to complete cardiopulmonary exercise test; (12) Participated in other trials within 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak Oxygen consumption(Peak VO2); | — |
Secondary
| Measure | Time frame |
|---|---|
| Echocardiography(LVEF,etc) ;Brain natriuretic peptide (BNP);European quality of life 5-dimensions (EQ-5D);Cardiac function classification, NYHA;Scores from the four TCM diagnostic method;Composite endpoints: including all-cause mortality, HF emergency/re -admission, acute coronary syndrome, revascularization, serious cardiac arrhythmias, cardiac shock, stroke, pulmonary embolism;urinary albumin excretion rate; | — |
Countries
China
Contacts
Public ContactZhao Zhiqiang
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed