Effect of Carvedilol Rapid Up-Titration in Patients With Heart Failure With Reduced Ejection Fraction
Study Details
Study Description
Brief Summary
Guidelines-directed medical therapy has improved dramatically outcomes in heart failure with reduced ejection fraction (HFrEF) patients. Beta-blockers have the most beneficial effects on all caused mortality and rehospitalization on HFrEF, but unfortunately, since the discovery of beta-blocker therapy in HFrEF, there was no change in the way of titration, start low go slow, which resulted in difficulties in reaching optimal doses for some patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
This study is a randomized controlled trial, single-center study in HFrEF patients, that held in Universitas Sebelas Maret Hospital, Central Java, Indonesia. The investigators divided 26 HFrEF patients consecutively into two groups, the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively. And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks. Every patient will be checked for IL-6, TNF-α, NT-ProBNP, MDA, left ventricular Ejection Fraction, six minutes walking test, and Kansas City Cardiomyopathy Questionnaire on day 1, pre-discharge, and one month after hospitalization. The study was approved by the university ethics committee. The clinical parameters evaluated at admission were analyzed using variable comparative with Shapiro Wilk or one-way ANOVA, with three intervals analysis using repeated ANOVA (p<0.05).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: UpTitration the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively |
Drug: Carvedilol
the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively. And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks
Other Names:
|
| Active Comparator: Control And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks |
Drug: Carvedilol
the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively. And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Improvements of Biomolecular Parameters [1 month]
IL-6 in pg/ml, TNF-α in pg/ml, NT-ProBNP in pg/ml, Malondyaldehide nmol/ml
- Improvements of Clinical Parameters [1 month]
Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition) and 6 Minutes Walking Test in meters
- Improvements of Echocardiography Parameters [1 month]
LVEF
Secondary Outcome Measures
- Major Adverse Cardiac Events [1 month]
All cause cardiac rehospitalization
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Acute heart failure patient with reduced ejection fraction in Universitas Sebelas Maret Hospital with naive betablocker therapy
-
Age >18 years old
-
Initial Heart Rate > 50 bpm
Exclusion Criteria:
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Cardiogenic Shock
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Septicaemia
-
High degree AV Block or on pace maker
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History of beta blocker intolerance
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Reactive Pulmonary disease
-
Severe Peripheral artery disease
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Creatinine level > 2.5 mg/dl
-
Potassium serum >5 mmol/L
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitas Sebelas Maret Hospital | Sukoharjo | Central Of Java | Indonesia | 57161 |
Sponsors and Collaborators
- Universitas Sebelas Maret
Investigators
- Principal Investigator: Habibie Arifianto, MD, Universitas Sebelas Maret
Study Documents (Full-Text)
None provided.More Information
Publications
- Martínez-Sellés M, Datino T, Alhama M, Barrueco N, Castillo I, Fernández-Avilés F. Rapid carvedilol up-titration in hospitalized patients with left ventricular systolic dysfunction--data from the Carvedilol in Hospital: Up-titration Limits after Acute Patients Admission registry. J Cardiovasc Med (Hagerstown). 2010 May;11(5):352-8. doi: 10.2459/JCM.0b013e328334f48b.
- Wolfe NK, Mitchell JD, Brown DL. The independent reduction in mortality associated with guideline-directed medical therapy in patients with coronary artery disease and heart failure with reduced ejection fraction. Eur Heart J Qual Care Clin Outcomes. 2021 Jul 21;7(4):416-421. doi: 10.1093/ehjqcco/qcaa032.
- Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28.
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