Heart failure with normal ejection fraction
Conditions
Interventions
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
41 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age>40 years old; 2. Heart failure as defined by at least one of the following symptoms at the time of screening and at least one of the following signs within 12 months prior to study entry: (1) Symptoms: dyspnea on mild or moderate exertion or paroxysmal nocturnal dyspnea or orthopnea; (2) Signs: any rales of lung or both lower extremity edema or chest x-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly; 3. LVEF more than 50% measured by echocardiography in modified Simpson method while LV end-diastolic volume index13; (2) If 850y50y>280ms or LA>4.7cm or LVMI>122g/m2 for female or LVMI>149g/m2 for male or SWTD/PWTD>=1.1 or BNP>=200pg/ml (or NT-proBNP>=220pg/ml) within the 12 months prior to study entry is needed; 4. 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. Participated in other trials within 2 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac function classification, NYHA;Lee's failure score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Minnesota life quality scale;European quality of life 5-dimensions (EQ-5D);Hospital anxiety and depression scale (HAD);Scores from the four TCM diagnostic method;6MWT distance;Echocardiography;Brain natriuretic peptide (BNP);sST2, etc.; | — |
Countries
China
Contacts
Public ContactZhao Zhiqiang
Outcome results
None listed