Using carvedilol to treat heart failure with preserved ejection fraction
Slow-release CArvedilol in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study
This study is testing if a medication called carvedilol can help people with heart failure and high blood pressure feel better and improve their heart function over six months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Seoul National University Bundang Hospital Academic / other |
| Locations | 2 sites (Seoul, Il-won and 1 other locations) |
| Trial ID | NCT05553314 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of slow-release carvedilol in patients suffering from heart failure with preserved ejection fraction (HFpEF) and hypertension. It aims to determine the impact of carvedilol on NT-proBNP levels and global longitudinal strain (GLS) over a six-month period. Participants will be randomly assigned to receive either carvedilol or a placebo, with the primary endpoint focusing on changes in biomarkers and heart function. The study builds on previous findings that suggest beta-blockers may improve outcomes in specific subgroups of HFpEF patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 years and older with symptomatic HFpEF, elevated NT-proBNP levels, and hypertension.
Not a fit: Patients with contraindications to beta-blockers or those with severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with HFpEF, potentially improving their heart function and overall health outcomes.
How similar studies have performed: Previous studies have shown that beta-blockers can improve outcomes in heart failure patients with reduced ejection fraction, but their efficacy in HFpEF remains less established, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul, Il-won and 1 other locations
- Samsung Medical Center — Seoul, Il-won, Korea, Republic of (Recruiting)
- Wonju Severance Christian Hospital — Wonju, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Dong-Ju Choi, MD, PhD — Seoul National Univeristy Bundang Hospital
- Study coordinator: Jin Joo Park, MD, PhD
- Email: jinjooparkmd@gmail.com
- Phone: +82317877074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.