Carvedilol in HF With Preserved EF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2024-12-30

Brief Summary

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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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Detailed Description

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Conditions

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Heart Failure With Preserved Ejection Fraction Beta Blocker Myocardial Strain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Carvedilol-group

Patients receiving carvedilol

Group Type EXPERIMENTAL

Carvedilol

Intervention Type DRUG

patients randomized to carvedilol group will receive carvedilol-SR.

Placebo-group

Patients receiving placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

patients randomized to placebo group will receive placebo.

Interventions

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Carvedilol

patients randomized to carvedilol group will receive carvedilol-SR.

Intervention Type DRUG

Placebo

patients randomized to placebo group will receive placebo.

Intervention Type DRUG

Other Intervention Names

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carvedilol slow-release (SR)

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No