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Heart Failure With Preserved Ejection FractionPhase 4NCT05553314

Carvedilol in HF With Preserved EF

A Phase 4 study testing Carvedilol in people with Heart Failure With Preserved Ejection Fraction and Beta Blocker, run by Seoul National University Bundang Hospital at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Carvedilol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
2 sitesSouth Korea
Study dates
17 Nov 2021to 8 Jan 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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%

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Samsung Medical Center

    Seoul, Il-won, 06351

  • Wonju Severance Christian Hospital

    Wŏnju, WONJU, 26426

Other trials in South Korea

About this study

Official 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

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.

Being tested
Carvedilol, Placebo
Keywords
HFPEF, beta-blocker, reduced strain, BNP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarvedilolDrug

    Also called carvedilol slow-release (SR)

    patients randomized to carvedilol group will receive carvedilol-SR.

  • PlaceboDrug

    patients randomized to placebo group will receive placebo.

Study groups in NCT05553314
Study groupRoleWhat they receive
Carvedilol-groupExperimentalPatients receiving carvedilol
Receives: Drug: Carvedilol
Placebo-groupPlacebo comparatorPatients receiving placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NT-proBNP change

    Time averaged NT-proBNP change from baseline to 6 months

    Measured: 6 months

  2. GLS change

    Change of GLS from baselin to 6 months

    Measured: 6 months

Secondary outcomes (3)

  1. off-level NT-proBNP

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

    Measured: 6 months

  2. Mortality

    All-cause mortality from baseline to 6 months

    Measured: 6 months

  3. rehospitalization

    rehospitalization from baseline to 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2022
  2. Study start17 Nov 2021
  3. Primary completion8 Jan 2026
  4. Study completion8 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective, randomized, double-blinded, placebo-controlled study
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05553314
Sponsor's protocol ID
CARE-preserved HF
Status last verified
May 2026
First submitted
20 Sep 2022
Last updated
19 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park JJ, Park JB, Park JH, Cho GY. Global Longitudinal Strain to Predict Mortality in Patients With Acute Heart Failure. J Am Coll Cardiol. 2018 May 8;71(18):1947-1957. doi: 10.1016/j.jacc.2018.02.064.

    PubMed 29724346

  • Yamamoto K, Origasa H, Hori M; J-DHF Investigators. Effects of carvedilol on heart failure with preserved ejection fraction: the Japanese Diastolic Heart Failure Study (J-DHF). Eur J Heart Fail. 2013 Jan;15(1):110-8. doi: 10.1093/eurjhf/hfs141. Epub 2012 Sep 14.

    PubMed 22983988

  • Park JJ, Choi HM, Hwang IC, Park JB, Park JH, Cho GY. Myocardial Strain for Identification of beta-Blocker Responders in Heart Failure with Preserved Ejection Fraction. J Am Soc Echocardiogr. 2019 Nov;32(11):1462-1469.e8. doi: 10.1016/j.echo.2019.06.017. Epub 2019 Sep 17.

    PubMed 31540679

  • Yoon M, Park SJ, Yoo BS, Choi DJ. The effect of sustained-release CARvedilol in patients with hypErtension and heart failure with preserved ejection fraction: a study protocol for a pilot randomized controlled trial (CARE-preserved HF). Front Cardiovasc Med. 2024 Apr 26;11:1375003. doi: 10.3389/fcvm.2024.1375003. eCollection 2024.

    PubMed 38737708

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Carvedilol in people with Heart Failure With Preserved Ejection Fraction and Beta Blocker, run by Seoul National University Bundang Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NT-proBNP change (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05553314, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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