Carvedilol in HF With Preserved EF

Phase 4

Recruiting

• Conditions: Heart Failure With Preserved Ejection Fraction; Beta Blocker; Myocardial Strain
• Interventions: Drug: Carvedilol; Drug: Placebo

• Registration Number: NCT05553314
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-17
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-23
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-03
• Last Update Posted: 2023-11-08
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carvedilol-group	Carvedilol	Patients receiving carvedilol
Placebo-group	Placebo	Patients receiving placebo

Primary Outcome Measures

Name	Time	Method
GLS change	6 months	Change of GLS from baselin to 6 months
NT-proBNP change	6 months	Time averaged NT-proBNP change from baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Mortality	6 months	All-cause mortality from baseline to 6 months
rehospitalization	6 months	rehospitalization from baseline to 6 months
off-level NT-proBNP	6 months	Decrease in NT-proBNP \> 10% from baseline to 6 months

Trial Locations

Locations (2)

Samsung Medical Center; 🇰🇷 Seoul, Il-won, Korea, Republic of

Wonju Severance Christian Hospital; 🇰🇷 Wonju, Korea, Republic of