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Immediate Release Versus Slow Release Carvedilol in Heart Failure (SLOW-HF)

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ClinicalTrials.gov Identifier: NCT03209180
Recruitment Status : Unknown
Verified July 2017 by Dong-Ju Choi, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Chong Kun Dang Pharmaceutical Corp.
Information provided by (Responsible Party):
Dong-Ju Choi, Seoul National University Bundang Hospital

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

Condition or disease Intervention/treatment Phase
Heart Failure With Reduced Ejection Fraction Drug: CarVeDilol-SR (Slow Release) Drug: Carvedilol IR (Immediate Release) Phase 4

Detailed Description:

The SLOW-HF trial is a phase 4, randomized, open label, multicenter study to evaluate the therapeutic efficacy of carvedilol-SR compared to carvedilol-IR in patients with heart failure with reduced ejection fraction. Patients with stable HFrEF will be randomly assigned (1:1) to carvedilol SR group (160 patients) and carvedilol IR group (160 patients).

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PROBE and NON-INFERIORITY DESIGN for Slow Release CarVeDilol-SR to Rapid Release Carvedilol-IR
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Clinical Effect and Treatment Quality of Rapid Release Carvedilol Versus SLOW Release Carvedilol-SR in HEART FAILURE Patient (SLOW-HF): A Prospective Randomized, Open-label, Multicenter Study
Actual Study Start Date : October 27, 2016
Estimated Primary Completion Date : June 25, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Carvedilol IR (Immediate Release)
Carvedilol IR 3.125mg, 6.25mg, 12.5mg, 25mg twice daily p.o. for 6 months
Drug: Carvedilol IR (Immediate Release)
patients will receive immediate release carvedilol (IR) twice daily

Experimental: CarVeDilol-SR (Slow Release)
CarVeDilol-SR 8mg, 16mg, 32mg, 64mg once daily p.o. for 6 months
Drug: CarVeDilol-SR (Slow Release)
patients will receive slow-release carvedilol (SR) once daily




Primary Outcome Measures :
  1. NT-proBNP [ Time Frame: 6 months ]
    Change of NT-proBNP from baseline to 6 months after randomization


Secondary Outcome Measures :
  1. All-cause Death [ Time Frame: 6 months ]
    Difference in all-cause deaths between the groups during clinical follow-up

  2. Hospitalization [ Time Frame: 6 months ]
    Difference in hospitalization for heart failure between the groups during clinical follow-up

  3. Blood Pressure [ Time Frame: 6 months ]
    Difference in blood pressure change between the groups during clinical follow-up

  4. Dyspnea [ Time Frame: 6 months ]
    Differences in dyspnea measured with visual analogue scale between the groups during clinical follow-up

  5. Drug compliance [ Time Frame: 6 months ]
    Differences in drug compliance measured with 'pill-count' between the groups during clinical follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. At least or more than 20-years-old male and female
  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:

  1. Systolic blood pressure at sitting position < 90mmHg or resting heart rate < 50 /min at screening
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209180


Locations
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Korea, Republic of
Sejong Hospital Recruiting
Gyeonggi-do, Bucheon, Korea, Republic of, 14754
Contact: Suk-keun Hong, MD    82-10-8947-5309    hongsk11@hanmail.net   
Gangdong Sacred Heart Hospital Recruiting
Seoul, Gangdong, Korea, Republic of, 05355
Contact: Dae-gyun Park, MD    82-2-2224-2379    dgpark@hallym.or.kr   
Korea Univ. Guro Hospital Recruiting
Seoul, Guro, Korea, Republic of, 08308
Contact: Eung-joo Kim, MD,PhD    82-8-2626-3022    withnoel@empas.com   
Samsung Medical Center Recruiting
Seoul, Il-won, Korea, Republic of, 06351
Contact: Eun-Seok Jeon, MD,PhD    82-2-3410-3448    esjeon1107@gmail.com   
Seoul Medical Center Recruiting
Seoul, Jungnang, Korea, Republic of, 02053
Contact: Seok-Yeon Kim, MD    82-2-2276-7095    ks7688@hanmail.net   
Korea Univ. Anam Hospital Recruiting
Seoul, Seongbuk, Korea, Republic of, 02841
Contact: Sun-jun Hong, MD,PhD    82-2-920-5445    psyche94@hanmail.net   
Asan Medical Center Recruiting
Seoul, Songpa, Korea, Republic of, 05505
Contact: Jae-Joong Kim, MD,PhD    82-2-3010-3154    jjkim@amc.seoul.kr   
Ajou Univ. Medical Center Recruiting
Suwon-si, Yeong-tong, Korea, Republic of, 16499
Contact: Jun-han Shin, MD,PhD    82-31-219-5710    shinjh@ajou.ac.kr   
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463707
Contact: Dong-Ju Choi, MD, PhD    82-31-787-7007    djchoi@snubh.org   
Contact: Jin Joo Park, MD    82-31-787 ext 7074    jinjooparkmd@gmail.com   
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Seok-Min Kang, MD,PhD    82-2-2273-3339    smkang@yuhs.ac   
Seoul Metropolitan Government Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 07061
Contact: Myung-a Kim    82-2-870-2213    kma@brmh.org   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110744
Contact: Hae-Young Lee, MD,Ph D    82-2-2072-4875    hylee612@gmail.com   
Wonju Severance Christian Hospital Recruiting
Wonju, Korea, Republic of, 26426
Contact: Byung-Su Yoo, MD,PhD    82-33-741-0908    yubs@yonsei.ac.kr   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Chong Kun Dang Pharmaceutical Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dong-Ju Choi, Professor, MD, PhD, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03209180     History of Changes
Other Study ID Numbers: CVDSR
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dong-Ju Choi, Seoul National University Bundang Hospital:
HFrEF
Carvedilol
Slow Release
NT-proBNP
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists