NCT05553314CompletedPhase 4
Carvedilol in HF With Preserved EF
Slow-release CArvedilol in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 20 Sept 2022
- Start date
- 17 Nov 2021
- Primary completion date
- 8 Jan 2026
- Lead sponsor
- Seoul National University Bundang Hospital
- Diseases
- Heart failure
- NCT number
- NCT05553314
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 63
- From 17 Nov 2021 to the primary completion date, 8 Jan 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- amyloidosis, hypertrophic cardiomyopathy with obstruction, severe aortic or mitral valve disease, acute coronary syndrome, Cerebrovascular event within 6 months, PCI within 3 months before
Other illness
- systolic blood pressure \< 110 mmHg, or heart rate \< 60 beats/min
Lab values
- creatinine\> 2.4mg/dL
- AST/ALT \>3 x normal upper range
Other
- contra-indication to beta-blockers
Who the study is looking for
- 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
- Average E/e'≥ 9
- Septal e' \< 7 cm/s
- Lateral e' \<10 cm/s
- TR velocity \> 2.8 m/s
- PASP \> 35 mmHg
- GLS \< 16%
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.