Carvedilol in HF With Preserved EF

Heart Failure With Preserved Ejection Fraction Clinical Trial

Official title:

Slow-release CArvedilol in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553314
• Other study ID #: CARE-preserved HF
• Status: Recruiting
• Phase: Phase 4
• Start date: November 17, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Bundang Hospital
• Contact: Jin Joo Park, MD, PhD
• Phone: +82317877074
• Email: jinjooparkmd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Beta Blocker
• Heart Failure
• Heart Failure With Preserved Ejection Fraction
• Myocardial Strain
• Sprains and Strains

Intervention

Drug:
• Carvedilol
patients randomized to carvedilol group will receive carvedilol-SR.
• Placebo
patients randomized to placebo group will receive placebo.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul	Il-won
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Samsung Medical Center, Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Park JJ, Choi HM, Hwang IC, Park JB, Park JH, Cho GY. Myocardial Strain for Identification of beta-Blocker Responders in Heart Failure with Preserved Ejection Fraction. J Am Soc Echocardiogr. 2019 Nov;32(11):1462-1469.e8. doi: 10.1016/j.echo.2019.06.017. — View Citation

Park JJ, Park JB, Park JH, Cho GY. Global Longitudinal Strain to Predict Mortality in Patients With Acute Heart Failure. J Am Coll Cardiol. 2018 May 8;71(18):1947-1957. doi: 10.1016/j.jacc.2018.02.064. — View Citation

Yamamoto K, Origasa H, Hori M; J-DHF Investigators. Effects of carvedilol on heart failure with preserved ejection fraction: the Japanese Diastolic Heart Failure Study (J-DHF). Eur J Heart Fail. 2013 Jan;15(1):110-8. doi: 10.1093/eurjhf/hfs141. Epub 2012 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NT-proBNP change	Time averaged NT-proBNP change from baseline to 6 months	6 months
Primary	GLS change	Change of GLS from baselin to 6 months	6 months
Secondary	off-level NT-proBNP	Decrease in NT-proBNP > 10% from baseline to 6 months	6 months
Secondary	Mortality	All-cause mortality from baseline to 6 months	6 months
Secondary	rehospitalization	rehospitalization from baseline to 6 months	6 months