Immediate Release Versus Slow Release Carvedilol in Heart Failure

NCT03209180 | Unknown Phase 4

• 1 other identifier: CVDSR
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 13

Brief Summary

Assessment of clinical effect and treatment quality of immediate release carvedilol (IR) versus slow release carvedilol (SR) in patients with HFrEF

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

HFrEF; Carvedilol; Slow Release; NT-proBNP

Outcome Measures

Primary Outcomes (1)

• NT-proBNP

  Change of NT-proBNP from baseline to 6 months after randomization

  6 months

Secondary Outcomes (5)

• All-cause Death

  6 months

• Hospitalization

  6 months

• Blood Pressure

  6 months

• Dyspnea

  6 months

• Drug compliance

  6 months

Study Arms (2)

Carvedilol IR (Immediate Release)

ACTIVE COMPARATOR

Carvedilol IR 3.125mg, 6.25mg, 12.5mg, 25mg twice daily p.o. for 6 months

Drug: Carvedilol IR (Immediate Release)

CarVeDilol-SR (Slow Release)

EXPERIMENTAL

CarVeDilol-SR 8mg, 16mg, 32mg, 64mg once daily p.o. for 6 months

Drug: CarVeDilol-SR (Slow Release)

Interventions

CarVeDilol-SR (Slow Release) DRUG

patients will receive slow-release carvedilol (SR) once daily

CarVeDilol-SR (Slow Release)

Carvedilol IR (Immediate Release) DRUG

patients will receive immediate release carvedilol (IR) twice daily

Carvedilol IR (Immediate Release)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least or more than 20-years-old male and female
• Confirmed left ventricular ejection fraction ≤40% by echocardiography within pre-analytical 6 months
• NT-proBNP level ≥ 125 pg/ml or BNP level ≥ 35 pg/ml within pre-analytical 3 months
• Clinically stable patient without evidence of congestion or extracellular fluid retention; those could be candidate of β-blockers
• Patients providing written informed consent

You may not qualify if:

• Systolic blood pressure at sitting position \< 90mmHg or resting heart rate \< 50 /min at screening
• Patient has a contraindication to β-blockers
• Patient who are expected to take another β-blocker after randomization
• 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
• Severe cerebrovascular accident (for example, ischemic stroke or cerebral hemorrhage) pre-analytical within 6 months
• Glottis edema, allergic rhinitis, respiratory diseases with bronchospasm such as asthma and chronic obstructive lung disease
• Peripheral vascular disease (for example, Raynaud syndrome, intermittent claudication)
• Patients who need vasopressor due to prominent volume retention/overload
• Moderate to Severe retinopathy (for example, retinal hemorrhage, visual disturbance, retinal microaneurysm within 6 months)
• Impaired renal function (Serum creatinine ≥ 2.5 mg/dL) or hepatic function (AST or ALT ≥ 3 x ULM)

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Chong Kun Dang Pharmaceutical Corp.: collaborator

Study Sites (13)

Sejong Hospital

Gyeonggi-do, Bucheon, 14754, South Korea

RECRUITING

Gangdong Sacred Heart Hospital

Seoul, Gangdong, 05355, South Korea

RECRUITING

Korea Univ. Guro Hospital

Seoul, Guro, 08308, South Korea

RECRUITING

Samsung Medical Center

Seoul, Il-won, 06351, South Korea

RECRUITING

Seoul Medical Center

Seoul, Jungnang, 02053, South Korea

RECRUITING

Korea Univ. Anam Hospital

Seoul, Seongbuk, 02841, South Korea

RECRUITING

Asan Medical Center

Seoul, Songpa, 05505, South Korea

RECRUITING

Ajou Univ. Medical Center

Suwon, Yeong-tong, 16499, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, 463707, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110744, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, 26426, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 35066737 DERIVED

• 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.

  PMID: 29433525 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: PROBE and NON-INFERIORITY DESIGN for Slow Release CarVeDilol-SR to Rapid Release Carvedilol-IR

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 6, 2017
• Study Start: October 27, 2016
• Primary Completion: June 25, 2018
• Study Completion: December 31, 2018
• Last Updated: July 6, 2017

Record last verified: 2017-07

Locations

KR (13)