Carvedilol in HF With Preserved EF

Last updated: November 3, 2023
Sponsor: Seoul National University Bundang Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Hyponatremia

Congestive Heart Failure

Chest Pain

Treatment

Placebo

Carvedilol

Clinical Study ID

NCT05553314
CARE-preserved HF
  • Ages > 20
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 mitralvalve disease, acute coronary syndrome, Cerebrovascular event within 6 months, PCIwithin 3 months before
  • AST/ALT >3 x normal upper range

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
November 17, 2021
Estimated Completion Date:
December 30, 2024

Connect with a study center

  • Samsung Medical Center

    Seoul, Il-won 06351
    Korea, Republic of

    Active - Recruiting

  • Wonju Severance Christian Hospital

    Wonju, 26426
    Korea, Republic of

    Active - Recruiting

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