Heart Failure With Reduced Ejection Fraction HFrEF
Conditions
Keywords
HFrEF, Carvedilol, Rapid UpTitration, Heart Failure
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.
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).
Interventions
DRUGCarvedilol
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
Sponsors
Universitas Sebelas Maret
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Patient, Care Provider and Investigator didn't know about dose of carvedilol and grouping of the patient.
Intervention model description
Devided into 2 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
* Cardiogenic Shock * Septicaemia * High degree AV Block or on pace maker * History of beta blocker intolerance * Reactive Pulmonary disease * Severe Peripheral artery disease * Creatinine level \> 2.5 mg/dl * Potassium serum \>5 mmol/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvements of Echocardiography Parameters | 1 month | LVEF |
| 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 Biomolecular Parameters | 1 month | IL-6 in pg/ml, TNF-α in pg/ml, NT-ProBNP in pg/ml, Malondyaldehide nmol/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac Events | 1 month | All cause cardiac rehospitalization |
Countries
Indonesia
Contacts
Primary ContactHabibie Arifianto, MD
Backup ContactAuliya B Nuriana, MD
Outcome results
None listed