Immediate Release Versus Slow Release Carvedilol in Heart Failure
NCT ID: NCT03209180
Last Updated: 2017-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
320 participants
INTERVENTIONAL
2016-10-27
2018-12-31
Brief Summary
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Detailed Description
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After randomization, patients will be followed for 6 months. The primary endpoint is the change in NT-proBNP level from baseline to the study end. The secondary endpoints include the frequency of NT-proBNP increment \>10% from baseline, composite of all-cause mortality and readmission, mortality rate, readmission rate, changes in blood pressure, quality of life, and drug compliance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Carvedilol IR (Immediate Release)
Carvedilol IR 3.125mg, 6.25mg, 12.5mg, 25mg twice daily p.o. for 6 months
Carvedilol IR (Immediate Release)
patients will receive immediate release carvedilol (IR) twice daily
CarVeDilol-SR (Slow Release)
CarVeDilol-SR 8mg, 16mg, 32mg, 64mg once daily p.o. for 6 months
CarVeDilol-SR (Slow Release)
patients will receive slow-release carvedilol (SR) once daily
Interventions
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CarVeDilol-SR (Slow Release)
patients will receive slow-release carvedilol (SR) once daily
Carvedilol IR (Immediate Release)
patients will receive immediate release carvedilol (IR) twice daily
Eligibility Criteria
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Inclusion Criteria
2. Confirmed left ventricular ejection fraction ≤40% by echocardiography within pre-analytical 6 months
3. NT-proBNP level ≥ 125 pg/ml or BNP level ≥ 35 pg/ml within pre-analytical 3 months
4. Clinically stable patient without evidence of congestion or extracellular fluid retention; those could be candidate of β-blockers
5. Patients providing written informed consent
Exclusion Criteria
2. Patient has a contraindication to β-blockers
3. Patient who are expected to take another β-blocker after randomization
4. Cardiovascular diseases
* Ischemic heart disease (unstable angina, myocardial infarction) within 1 month
* Hypertrophic cardiomyopathy
* Cor pulmonale
* Hemodynamically significant stenosis of aorta, aortic valve, or mitral valve
* any acute myocardial infarction with complication
5. Severe cerebrovascular accident (for example, ischemic stroke or cerebral hemorrhage) pre-analytical within 6 months
6. Glottis edema, allergic rhinitis, respiratory diseases with bronchospasm such as asthma and chronic obstructive lung disease
7. Peripheral vascular disease (for example, Raynaud syndrome, intermittent claudication)
8. Patients who need vasopressor due to prominent volume retention/overload
9. Moderate to Severe retinopathy (for example, retinal hemorrhage, visual disturbance, retinal microaneurysm within 6 months)
10. Impaired renal function (Serum creatinine ≥ 2.5 mg/dL) or hepatic function (AST or ALT ≥ 3 x ULM)
11. Patients in clinical status that can significantly influence on absorption, distribution, metabolism, and secretion of drugs for clinical trial
* history of major gastrointestinal surgery, such as gastrectomy or gastric bypass surgery
* inflammatory bowel disease within 12 months
* current gastric ulcer, pancreatic function abnormality including pancreatitis, gastrointestinal/rectal bleeding which demand treatment
* current urologic stenosis or obstruction which demand treatment
12. Confirmed or suspected drug/alcohol abuse within 6 months
13. Pregnant or lactating women, suspected pregnant women or lactating women
14. Chronic inflammatory diseases which demand anti-inflammatory treatment
15. Hypersensitivity to carvedilol
16. Malignant disease including lymphoma and leukemia within 5 years
17. Patients who were prescribed other medication for any clinical trials pre-analytical within 28 days
18. Patients who are predicted to have prolonged hospital days due to other medical problems other than chronic heart failure (for example, femur neck fracture)
19. Patients who are considered as inappropriate to participate in the clinical trial by testers
20 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical Corp.
INDUSTRY
Seoul National University Bundang Hospital
OTHER
Responsible Party
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Dong-Ju Choi
Professor, MD, PhD
Locations
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Sejong Hospital
Gyeonggi-do, Bucheon, South Korea
Gangdong Sacred Heart Hospital
Seoul, Gangdong, South Korea
Korea Univ. Guro Hospital
Seoul, Guro, South Korea
Samsung Medical Center
Seoul, Il-won, South Korea
Seoul Medical Center
Seoul, Jungnang, South Korea
Korea Univ. Anam Hospital
Seoul, Seongbuk, South Korea
Asan Medical Center
Seoul, Songpa, South Korea
Ajou Univ. Medical Center
Suwon, Yeong-tong, South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Severance Hospital
Seoul, , South Korea
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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Facility Contacts
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References
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Park CS, Park JJ, Lee HY, Kang SM, Yoo BS, Jeon ES, Hong SK, Shin JH, Kim MA, Park DG, Kim EJ, Hong SJ, Kim SY, Kim JJ, Choi DJ. Clinical Characteristics and Outcome of Immediate-Release Versus SLOW-Release Carvedilol in Heart Failure Patient (SLOW-HF): a Prospective Randomized, Open-Label, Multicenter Study. Cardiovasc Drugs Ther. 2023 Jun;37(3):529-537. doi: 10.1007/s10557-021-07238-3. Epub 2022 Jan 23.
Choi DJ, Park CS, Park JJ, Lee HY, Kang SM, Yoo BS, Jeon ES, Hong SK, Shin JH, Kim MA, Park DG, Kim EJ, Hong SJ, Kim SY, Kim JJ. Assessment of clinical effect and treatment quality of immediate-release carvedilol-IR versus SLOW release carvedilol-SR in Heart Failure patients (SLOW-HF): study protocol for a randomized controlled trial. Trials. 2018 Feb 13;19(1):103. doi: 10.1186/s13063-018-2470-5.
Other Identifiers
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CVDSR
Identifier Type: -
Identifier Source: org_study_id
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