heart failure patients with preserved ejection fraction and Cpc-PH
Conditions
Interventions
experimental group:tadalafil20mg Qd+conventional treatment
control group:Conventional treatment
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age =40 years, regardless of gender. 2) HFpEF confirmed meets the following three criteria: A. Symptoms (NYHA class ii-iv) and/or signs of heart failure; B. NT-proBNP >= 400 pg/mL; C. LVEF >= 45%. 3) Pre-capillary and post-capillary mixed pulmonary hypertension, which meets the following two criteria: A.DPG >= 7 mmHg and/or PVR > 3 WU. B.PCWP >= 15 mm or PCWP >= 25 mmHg during 20-watt exercise. 4) Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Other known causes of pulmonary hypertension; 2) Chronic lung disease; 3) Acute or chronic pulmonary thromboembolism; 4) Known myocardial diseases and pericardial diseases, including: restrictive cardiomyopathy, hypertrophic cardiomyopathy, and constrictive pericarditis; 5) Severe valvular heart disease (stenosis or reflux above moderate to severe); 6) Unstable coronary atherosclerotic heart disease, such as acute coronary syndrome and recent revascularization (3 months); 7) Cardiopulmonary exercise test cannot be performed; 8) Cannot tolerate the study drug for hypotension or other reasons, such as galactose intolerance, being treated with a-receptor blocker or a powerful CYP3A4 inhibitor (e.g., ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin); 9) Severe liver and kidney dysfunction (ALT or AST greater than normal or equal to three times the upper limit, estimated glomerular filtration rate less than or equal to 30ml/min); 10) Pregnancy or breastfeeding; 11) The life expectancy of malignant tumors is less than 2 years; 12) Other conditions are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PVO2; | — |
Secondary
| Measure | Time frame |
|---|---|
| VE/VCO2 slope;composite end point: hospitalization for all causes of death and cardiovascular disease;mPAP;NT-proBNP level in plasma;6-minute walking distance;Minnesota heart failure questionnaire score; | — |
Countries
China
Contacts
Public ContactYihong Sun
China-Japan Friendship Hospital
Outcome results
None listed