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| Name | Class |
|---|---|
| Samsung Medical Center | OTHER |
| Wonju Severance Christian Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol-group | Experimental | Patients receiving carvedilol |
|
| Placebo-group | Placebo Comparator | Patients receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | patients randomized to carvedilol group will receive carvedilol-SR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NT-proBNP change | Time averaged NT-proBNP change from baseline to 6 months | 6 months |
| GLS change | Change of GLS from baselin to 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| off-level NT-proBNP | Decrease in NT-proBNP > 10% from baseline to 6 months | 6 months |
| Mortality | All-cause mortality from baseline to 6 months |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Ju Choi, MD, PhD | Seoul National Univeristy Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | Il-won | 06351 | South Korea | ||
| Wonju Severance Christian Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29724346 | Result | 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. | |
| 22983988 | Result | 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. |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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A prospective, randomized, double-blinded, placebo-controlled study
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| Placebo | Drug | patients randomized to placebo group will receive placebo. |
|
| 6 months |
| rehospitalization | rehospitalization from baseline to 6 months | 6 months |
| Wŏnju |
| WONJU |
| 26426 |
| South Korea |
| 31540679 | Result | 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. |
| 38737708 | Derived | Yoon M, Park SJ, Yoo BS, Choi DJ. The effect of sustained-release CARvedilol in patients with hypErtension and heart failure with preserved ejection fraction: a study protocol for a pilot randomized controlled trial (CARE-preserved HF). Front Cardiovasc Med. 2024 Apr 26;11:1375003. doi: 10.3389/fcvm.2024.1375003. eCollection 2024. |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |