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

July 3, 2017 updated by: Dong-Ju Choi, Seoul National University Bundang Hospital

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 463707
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
          • Seok-Min Kang, MD,PhD
          • Phone Number: 82-2-2273-3339
          • Email: smkang@yuhs.ac
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
        • Contact:
          • Myung-a Kim
          • Phone Number: 82-2-870-2213
          • Email: kma@brmh.org
      • Seoul, Korea, Republic of, 110744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Wonju, Korea, Republic of, 26426
        • Recruiting
        • Wonju Severance Christian Hospital
    • Bucheon
      • Gyeonggi-do, Bucheon, Korea, Republic of, 14754
        • Recruiting
        • Sejong Hospital
        • Contact:
    • Gangdong
      • Seoul, Gangdong, Korea, Republic of, 05355
        • Recruiting
        • Gangdong Sacred Heart Hospital
        • Contact:
    • Guro
      • Seoul, Guro, Korea, Republic of, 08308
        • Recruiting
        • Korea Univ. Guro hospital
        • Contact:
    • Il-won
      • Seoul, Il-won, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
    • Jungnang
      • Seoul, Jungnang, Korea, Republic of, 02053
        • Recruiting
        • Seoul Medical Center
        • Contact:
    • Seongbuk
      • Seoul, Seongbuk, Korea, Republic of, 02841
        • Recruiting
        • Korea Univ. Anam Hospital
        • Contact:
    • Songpa
      • Seoul, Songpa, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Contact:
    • Yeong-tong
      • Suwon-si, Yeong-tong, Korea, Republic of, 16499
        • Recruiting
        • Ajou Univ. Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
NT-proBNP
Time Frame: 6 months
Change of NT-proBNP from baseline to 6 months after randomization
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All-cause Death
Time Frame: 6 months
Difference in all-cause deaths between the groups during clinical follow-up
6 months
Hospitalization
Time Frame: 6 months
Difference in hospitalization for heart failure between the groups during clinical follow-up
6 months
Blood Pressure
Time Frame: 6 months
Difference in blood pressure change between the groups during clinical follow-up
6 months
Dyspnea
Time Frame: 6 months
Differences in dyspnea measured with visual analogue scale between the groups during clinical follow-up
6 months
Drug compliance
Time Frame: 6 months
Differences in drug compliance measured with 'pill-count' between the groups during clinical follow-up
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Bundang Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chong Kun Dang Pharmaceutical Corp.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVDSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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