Beta Blocker, Heart Failure With Preserved Ejection Fraction, Myocardial Strain
Conditions
Keywords
HFPEF, beta-blocker, reduced strain, BNP
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.
Interventions
DRUGCarvedilol
patients randomized to carvedilol group will receive carvedilol-SR.
DRUGPlacebo
patients randomized to placebo group will receive placebo.
Sponsors
Seoul National University Bundang Hospital
Samsung Medical Center
Wonju Severance Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
A prospective, randomized, double-blinded, placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| off-level NT-proBNP | 6 months | Decrease in NT-proBNP \> 10% from baseline to 6 months |
| Mortality | 6 months | All-cause mortality from baseline to 6 months |
| rehospitalization | 6 months | rehospitalization from baseline to 6 months |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORDong-Ju Choi, MD, PhD
Seoul National Univeristy Bundang Hospital
Outcome results
None listed