CArvedilol SR in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    100
  • sponsor
    Seoul National University Bundang Hospital
Updated on 18 October 2022

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 carvedilol in patients with HF and EF > 40% and GLS < 14% and N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 400 pg/mL. The primary endpoint is the time-averaged proportional changes in NT-proBNP level from baseline through month 3. The secondary endpoints include the change in NT -proBNP at month 3 and month 6.

Details
Condition Heart Failure With Preserved Ejection Fraction, Beta Blocker, Myocardial Strain
Treatment Placebo, Carvedilol
Clinical Study IdentifierNCT05553314
SponsorSeoul National University Bundang Hospital
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

HFpEF > 40%
GLS < 14%
NT0proBNP > 400 pg/ml
no atrial fibrillation
beta-blocker naive

Exclusion Criteria

systolic blood pressure < 110 mmHg, heart rate < 60 beats/min
contra-indication to beta-blockers
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