Carvedilol in HF With Preserved EF

Seoul National University

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Placebo; Drug: Carvedilol

Study type: Interventional

Funder types: Other

Identifiers

NCT05553314

CARE-preserved HF

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Carvedilol-group

Experimental group

Description:

Patients receiving carvedilol

Treatment:

Drug: Carvedilol

Placebo-group

Placebo Comparator group

Description:

Patients receiving placebo

Treatment:

Drug: Placebo