Carvedilol in HF With Preserved EF

May 15, 2026 updated by: Dong-Ju Choi, Seoul National University Bundang Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Il-won
      • Seoul, Il-won, South Korea, 06351
        • Samsung Medical Center
    • WONJU
      • Wŏnju, WONJU, South Korea, 26426
        • Wonju Severance Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carvedilol-group
Patients receiving carvedilol
Drug: Carvedilol
patients randomized to carvedilol group will receive carvedilol-SR.
Other Names:
  • carvedilol slow-release (SR)
Placebo Comparator: Placebo-group
Patients receiving placebo
Drug: Placebo
patients randomized to placebo group will receive placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT-proBNP change
Time Frame: 6 months
Time averaged NT-proBNP change from baseline to 6 months
6 months
GLS change
Time Frame: 6 months
Change of GLS from baselin to 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
off-level NT-proBNP
Time Frame: 6 months
Decrease in NT-proBNP > 10% from baseline to 6 months
6 months
Mortality
Time Frame: 6 months
All-cause mortality from baseline to 6 months
6 months
rehospitalization
Time Frame: 6 months
rehospitalization from baseline to 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Samsung Medical Center
Wonju Severance Christian Hospital

Investigators

  • Principal Investigator: Dong-Ju Choi, MD, PhD, Seoul National Univeristy Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Actual)

January 8, 2026

Study Completion (Actual)

January 8, 2026

Study Registration Dates

First Submitted

September 20, 2022

First Submitted That Met QC Criteria

September 22, 2022

First Posted (Actual)

September 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARE-preserved HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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