Carvedilol in HF With Preserved EF

NCT05553314 | Unknown Phase 4

• 1 other identifier: CARE-preserved HF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure With Preserved Ejection Fraction; Beta Blocker; Myocardial Strain

Keywords

HFPEF; beta-blocker; reduced strain; BNP

Outcome Measures

Primary Outcomes (2)

• NT-proBNP change

  Time averaged NT-proBNP change from baseline to 6 months

  6 months

• GLS change

  Change of GLS from baselin to 6 months

  6 months

Secondary Outcomes (3)

• off-level NT-proBNP

  6 months

• Mortality

  6 months

• rehospitalization

  6 months

Study Arms (2)

Carvedilol-group

EXPERIMENTAL

Patients receiving carvedilol

Drug: Carvedilol

Placebo-group

PLACEBO COMPARATOR

Patients receiving placebo

Drug: Placebo

Interventions

Carvedilol DRUG

patients randomized to carvedilol group will receive carvedilol-SR.

Also known as: carvedilol slow-release (SR)

Carvedilol-group

Placebo DRUG

patients randomized to placebo group will receive placebo.

Placebo-group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Samsung Medical Center: collaborator
• Wonju Severance Christian Hospital: collaborator

Study Sites (2)

Samsung Medical Center

Seoul, Il-won, 06351, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

RECRUITING

Related Publications (4)

• 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.

  PMID: 29724346 RESULT

• 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.

  PMID: 22983988 RESULT

• 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.

  PMID: 31540679 RESULT

• 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.

  PMID: 38737708 DERIVED

MeSH Terms

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Dong-Ju Choi, MD, PhD

  Seoul National Univeristy Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Joo Park, MD, PhD

CONTACT

+82317877074; jinjooparkmd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, randomized, double-blinded, placebo-controlled study

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 23, 2022
• Study Start: November 17, 2021
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)