Back to resultsCarvedilol in HF With Preserved EF
Primary Purpose
Heart Failure With Preserved Ejection Fraction, Beta Blocker, Myocardial Strain
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Carvedilol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure With Preserved Ejection Fraction focused on measuring HFPEF, beta-blocker, reduced strain, BNP
Eligibility Criteria
Inclusion Criteria:
- age ≥20 yrs
- symptomatic HFpEF ≥50%
- NT-proBNP ≥240 pg/ml (sinus rhythm) or ≥660 pg/ml(AF) (BNP ≥100 pg/ml (sinus rhythm) or ≥300 pg/ml(AF) )
- SBP≥140mmHg and/or DBP ≥90mmHg or if taking anti-hypertensive medication, SBP ≥110mmHg.
- LAVI>34 ml/m2 or LVMI>149(male)/122(female) g/m2
meet one the following
- Average E/e'≥ 9
- Septal e' < 7 cm/s
- Lateral e' <10 cm/s
- TR velosity > 2.8 m/s
- PASP > 35 mmHg
- 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, PCI within 3 months before
Sites / Locations
- Samsung Medical CenterRecruiting
- Wonju Severance Christian HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Carvedilol-group
Placebo-group
Arm Description
Patients receiving carvedilol
Patients receiving placebo
Outcomes
Primary Outcome Measures
NT-proBNP change
Time averaged NT-proBNP change from baseline to 6 months
GLS change
Change of GLS from baselin to 6 months
Secondary Outcome Measures
off-level NT-proBNP
Decrease in NT-proBNP > 10% from baseline to 6 months
Full Information
NCT ID
NCT05553314
First Posted
September 20, 2022
Last Updated
October 18, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
Samsung Medical Center, Wonju Severance Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05553314
Brief Title
Carvedilol in HF With Preserved EF
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
August 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Samsung Medical Center, Wonju Severance Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Preserved Ejection Fraction, Beta Blocker, Myocardial Strain
Keywords
HFPEF, beta-blocker, reduced strain, BNP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized, double-blinded, placebo-controlled study
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carvedilol-group
Arm Type
Experimental
Arm Description
Patients receiving carvedilol
Arm Title
Placebo-group
Arm Type
Placebo Comparator
Arm Description
Patients receiving placebo
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Other Intervention Name(s)
carvedilol slow-release (SR)
Intervention Description
patients randomized to carvedilol group will receive carvedilol-SR.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
patients randomized to placebo group will receive placebo.
Primary Outcome Measure Information:
Title
NT-proBNP change
Description
Time averaged NT-proBNP change from baseline to 6 months
Time Frame
6 months
Title
GLS change
Description
Change of GLS from baselin to 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
off-level NT-proBNP
Description
Decrease in NT-proBNP > 10% from baseline to 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥20 yrs
symptomatic HFpEF ≥50%
NT-proBNP ≥240 pg/ml (sinus rhythm) or ≥660 pg/ml(AF) (BNP ≥100 pg/ml (sinus rhythm) or ≥300 pg/ml(AF) )
SBP≥140mmHg and/or DBP ≥90mmHg or if taking anti-hypertensive medication, SBP ≥110mmHg.
LAVI>34 ml/m2 or LVMI>149(male)/122(female) g/m2
meet one the following
Average E/e'≥ 9
Septal e' < 7 cm/s
Lateral e' <10 cm/s
TR velosity > 2.8 m/s
PASP > 35 mmHg
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, PCI within 3 months before
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Joo Park, MD, PhD
Phone
+82317877074
Email
jinjooparkmd@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Ju Choi, MD, PhD
Organizational Affiliation
Seoul National Univeristy Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Il-won
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Ji Park, MD,PhD
Phone
82-2-3410-3448
Email
tyche.park@gmail.com
Facility Name
Wonju Severance Christian Hospital
City
Wonju
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung-Su Yoo, MD,PhD
Phone
82-33-741-0908
Email
yubs@yonsei.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29724346
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.
Results Reference
result
PubMed Identifier
22983988
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 Sep 14.
Results Reference
result
PubMed Identifier
31540679
Citation
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. Epub 2019 Sep 17.
Results Reference
result
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Carvedilol in HF With Preserved EF
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