Carvedilol in HF With Preserved EF

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05553314

Collaborator

Samsung Medical Center (Other), Wonju Severance Christian Hospital (Other)

100

Enrollment

Locations

Arms

33.4

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure With Preserved Ejection Fraction Beta Blocker Myocardial Strain	Drug: Carvedilol Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A prospective, randomized, double-blinded, placebo-controlled studyA prospective, randomized, double-blinded, placebo-controlled study

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 17, 2021

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Aug 30, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

NT-proBNP change [6 months]
Time averaged NT-proBNP change from baseline to 6 months
GLS change [6 months]
Change of GLS from baselin to 6 months

Secondary Outcome Measures

off-level NT-proBNP [6 months]
Decrease in NT-proBNP > 10% from baseline to 6 months

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

age ≥20 yrs
symptomatic HFpEF ≥50%
NT-proBNP ≥240 pg/ml (sinus rhythm) or ≥660 pg/ml(AF) (BNP ≥100 pg/ml (sinus rhythm) or ≥300 pg/ml(AF) )
SBP≥140mmHg and/or DBP ≥90mmHg or if taking anti-hypertensive medication, SBP ≥110mmHg.
LAVI>34 ml/m2 or LVMI>149(male)/122(female) g/m2
meet one the following

Average E/e'≥ 9
Septal e' < 7 cm/s
Lateral e' <10 cm/s
TR velosity > 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, PCI within 3 months before