HFpEF
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Eligible patients were diagnosed of heart failure with preserved ejection fraction (HFpEF) with or without a history of cardiomyopathy; 2) Eligible patients(>=40 years of age) with New York Heart Association (NYHA) class II-IV; 3) N-terminal prohormone B-type natriuretic peptide (NT-proBNP) were more than 200 pg/mL in normal sinus rhythm or more than 600 pg/mL in atrial fibrillation; 4) Patients provided written informed consent to participate in the trial.
Exclusion criteria
Exclusion criteria: 1) Patients with severe right ventricular dysfunction, including a central venous pressure> 20 mm Hg, RAD>45mm or tricuspid annular plane systolic excursion below 14 mm; 2) Patients with pulmonary artery systolic pressure> 60mmHg estimated by transthoracic ultrasound, severe tricuspid regurgitation or with moderate/ severe mitral regurgitation; 3) Patients with moderate or severe liver and kidney dysfunction (alanine aminotransferase > 150 IU/L, and/or serum creatinine > 150 mmol/L); 4) Patients with myocardial infarction, unstable angina pectoris or cerebrovascular accident in the past 6 months; 5) Patients with congenital heart disease; 6) Patients had persistent atrial fibrillation without anticoagulation and/or suspected thrombus in the heart chamber; 7) Patients with valvular heart disease with surgical indications; 8) Patients with II/III heart block without pacemaker implantation; 9) Patients with abnormal coagulation function couldn't tolerate heparinization; 10) Patients with untreated cancer; 11) Pregnant women, in lactation or preparing to conceive; 12) Patients with active peptic ulcer or upper gastrointestinal bleeding within 3 months; 13) Patients with known allergy or contraindication to aspirin, heparin, clopidogrel, metal nitinol, or allergy to contrast medium that precludes appropriate preoperative medication; 14) Patients were also participating in other drug or device studies; 15) Patients with active infective endocarditis or other active infection; 16) Patients were unwilling to sign the informed consent; 17) Patients couldn't insist on complete follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left atrial CT;Transthoracic echocardiography (TTE);Transesophageal echocardiography (TEE);Intracardiac echocardiography;Right heart catheterization;hepatic and renal function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma NT-proBNP level;6 minutes walking distance;Cardiopulmonary exercise testing; | — |
Countries
China
Contacts
The First Affiliated Hospital of Nanjing Medical University