Heart Failure With Preserved Ejection Fraction Clinical Trial
Official title:
Slow-release CArvedilol in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study
Beta-blockers improve clinical outcomes in heart failure and reduced ejection fraction (HFrEF); but not in those with preserved EF. Global longitudinal strain (GLS) is a prognostic factor independent of left ventricular ejection fraction (LVEF). In a retrospective with 1969 patients with HF and LVEF of ≥40%, beta-blocker was associated with improved survival in those with low GLS (GLS <14%), but not in those with GLS ≥14%. In this prospective, randomized clinical study, the investigators will assess the effect of slow-release carvedilol in patients with HFpEF and hypertension. The primary endpoint is the time-averaged proportional changes in NT-proBNP level and GLS change from baseline to month 6.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2024 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - age =20 yrs - symptomatic HFpEF with LVEF=50% - NT-proBNP =220 pg/ml (sinus rhythm) or =660 pg/ml(AF) (BNP =80 pg/ml (sinus rhythm) or =240 pg/ml(AF) ) - SBP=140mmHg and/or DBP =90mmHg, or if taking anti-hypertensive medication, SBP =110mmHg. - LAVI=29(sinus rhythm)/34ml/m2 (AF) or LVMI=115(male)/95(female) g/m2 - meet one the following 1. Average E/e'= 9 2. Septal e' < 7 cm/s 3. Lateral e' <10 cm/s 4. TR velocity > 2.8 m/s 5. PASP > 35 mmHg 6. GLS < 16% Exclusion Criteria: - systolic blood pressure < 110 mmHg, or heart rate < 60 beats/min - contra-indication to beta-blockers - creatinine> 2.4mg/dL - amyloidosis, hypertrophic cardiomyopathy with obstruction, severe aortic or mitral valve disease, acute coronary syndrome, Cerebrovascular event within 6 months, PCI within 3 months before - AST/ALT >3 x normal upper range |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul | Il-won |
Korea, Republic of | Wonju Severance Christian Hospital | Wonju |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital | Samsung Medical Center, Wonju Severance Christian Hospital |
Korea, Republic of,
Park JJ, Choi HM, Hwang IC, Park JB, Park JH, Cho GY. Myocardial Strain for Identification of beta-Blocker Responders in Heart Failure with Preserved Ejection Fraction. J Am Soc Echocardiogr. 2019 Nov;32(11):1462-1469.e8. doi: 10.1016/j.echo.2019.06.017. — View Citation
Park JJ, Park JB, Park JH, Cho GY. Global Longitudinal Strain to Predict Mortality in Patients With Acute Heart Failure. J Am Coll Cardiol. 2018 May 8;71(18):1947-1957. doi: 10.1016/j.jacc.2018.02.064. — View Citation
Yamamoto K, Origasa H, Hori M; J-DHF Investigators. Effects of carvedilol on heart failure with preserved ejection fraction: the Japanese Diastolic Heart Failure Study (J-DHF). Eur J Heart Fail. 2013 Jan;15(1):110-8. doi: 10.1093/eurjhf/hfs141. Epub 2012 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NT-proBNP change | Time averaged NT-proBNP change from baseline to 6 months | 6 months | |
Primary | GLS change | Change of GLS from baselin to 6 months | 6 months | |
Secondary | off-level NT-proBNP | Decrease in NT-proBNP > 10% from baseline to 6 months | 6 months | |
Secondary | Mortality | All-cause mortality from baseline to 6 months | 6 months | |
Secondary | rehospitalization | rehospitalization from baseline to 6 months | 6 months |
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