Carvedilol in HF With Preserved EF

Launched by SEOUL NATIONAL UNIVERSITY BUNDANG HOSPITAL · Sep 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called carvedilol in patients who have heart failure with preserved ejection fraction (HFpEF) and high blood pressure. Unlike heart failure with reduced ejection fraction, where beta-blockers have been shown to help improve health outcomes, it’s not clear if they work the same way for patients with preserved ejection fraction. The researchers want to see if taking carvedilol can help lower levels of a specific substance in the blood (NT-proBNP) and improve heart function over six months.

To be eligible for this trial, participants must be at least 20 years old and have symptoms of heart failure with a preserved ejection fraction of 50% or more. They also need to have certain blood pressure levels and specific measurements related to heart function. Participants can expect to be closely monitored and will have tests to check their heart health and blood levels throughout the study. This trial is currently recruiting participants of all genders, and if you or someone you know meets the criteria, it could be an opportunity to contribute to important research in heart health.

Gender

ALL

Eligibility 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