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NCT Number: NCT05553314

Carvedilol in HF With Preserved EF

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Beta Blocker Myocardial Strain

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center, Seoul, Il-won, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • PASP > 35 mmHg
  • 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

Treatment and study plan

Carvedilol

Drug

patients randomized to carvedilol group will receive carvedilol-SR.

Other names: carvedilol slow-release (SR)

Placebo

Drug

patients randomized to placebo group will receive placebo.

Primary outcomes

  1. NT-proBNP change

    Time frame: 6 months

    Time averaged NT-proBNP change from baseline to 6 months

  2. GLS change

    Time frame: 6 months

    Change of GLS from baselin to 6 months

Secondary outcomes

  1. off-level NT-proBNP

    Time frame: 6 months

    Decrease in NT-proBNP > 10% from baseline to 6 months

  2. Mortality

    Time frame: 6 months

    All-cause mortality from baseline to 6 months

  3. rehospitalization

    Time frame: 6 months

    rehospitalization from baseline to 6 months

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Samsung Medical Center
  • Wonju Severance Christian Hospital

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2022
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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