Slow-release CArvedilol in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study
Overview
- Phase
- Phase 4
- Intervention
- Carvedilol
- Conditions
- Heart Failure With Preserved Ejection Fraction
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- GLS change
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Dong-Ju Choi
Professor
Seoul National University Bundang Hospital
Eligibility Criteria
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
- •Average E/e'≥ 9
- •Septal e' \< 7 cm/s
- •Lateral e' \<10 cm/s
- •TR velocity \> 2.8 m/s
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
Arms & Interventions
Carvedilol-group
Patients receiving carvedilol
Intervention: Carvedilol
Placebo-group
Patients receiving placebo
Intervention: Placebo
Outcomes
Primary Outcomes
GLS change
Time Frame: 6 months
Change of GLS from baselin to 6 months
NT-proBNP change
Time Frame: 6 months
Time averaged NT-proBNP change from baseline to 6 months
Secondary Outcomes
- Mortality(6 months)
- rehospitalization(6 months)
- off-level NT-proBNP(6 months)