AzTrials
AzTrials

Heart Failure With Reduced Ejection FractionPhase 4SLOW-HFNCT03209180

Immediate Release Versus Slow Release Carvedilol in Heart Failure

A Phase 4 study testing CarVeDilol-SR (Slow Release) and Carvedilol IR (Immediate Release) in people with Heart Failure With Reduced Ejection Fraction, run by Seoul National University Bundang Hospital at 13 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 20 years and older
What is being tested?
CarVeDilol-SR (Slow Release) and Carvedilol IR (Immediate Release)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
13 sitesSouth Korea
Study dates
27 Oct 2016to 31 Dec 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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)
  • 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
  • Confirmed or suspected drug/alcohol abuse within 6 months
  • Pregnant or lactating women, suspected pregnant women or lactating women
  • Chronic inflammatory diseases which demand anti-inflammatory treatment
  • Hypersensitivity to carvedilol
  • Malignant disease including lymphoma and leukemia within 5 years
  • Patients who were prescribed other medication for any clinical trials pre-analytical within 28 days
  • Patients who are predicted to have prolonged hospital days due to other medical problems other than chronic heart failure (for example, femur neck fracture)
  • Patients who are considered as inappropriate to participate in the clinical trial by testers

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

South Korea13 sites, 13 recruiting

  • Sejong Hospital

    Gyeonggi-do, Bucheon, 14754

    Suk-keun Hong, MD, 82-10-8947-5309, hongsk11@hanmail.net

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, 463707

    Dong-Ju Choi, MD, PhD, 82-31-787-7007, djchoi@snubh.org

    Jin Joo Park, MD, 82-31-787 ext. 7074, jinjooparkmd@gmail.com

    Recruiting

  • Gangdong Sacred Heart Hospital

    Seoul, Gangdong, 05355

    Dae-gyun Park, MD, 82-2-2224-2379, dgpark@hallym.or.kr

    Recruiting

  • Korea Univ. Guro Hospital

    Seoul, Guro, 08308

    Eung-joo Kim, MD,PhD, 82-8-2626-3022, withnoel@empas.com

    Recruiting

  • Samsung Medical Center

    Seoul, Il-won, 06351

    Eun-Seok Jeon, MD,PhD, 82-2-3410-3448, esjeon1107@gmail.com

    Recruiting

  • Seoul Medical Center

    Seoul, Jungnang, 02053

    Seok-Yeon Kim, MD, 82-2-2276-7095, ks7688@hanmail.net

    Recruiting

  • Korea Univ. Anam Hospital

    Seoul, Seongbuk, 02841

    Sun-jun Hong, MD,PhD, 82-2-920-5445, psyche94@hanmail.net

    Recruiting

  • Asan Medical Center

    Seoul, Songpa, 05505

    Jae-Joong Kim, MD,PhD, 82-2-3010-3154, jjkim@amc.seoul.kr

    Recruiting

  • Severance Hospital

    Seoul, 03722

    Seok-Min Kang, MD,PhD, 82-2-2273-3339, smkang@yuhs.ac

    Recruiting

  • Seoul Metropolitan Government Seoul National University Boramae Medical Center

    Seoul, 07061

    Myung-a Kim, 82-2-870-2213, kma@brmh.org

    Recruiting

  • Seoul National University Hospital

    Seoul, 110744

    Hae-Young Lee, MD,Ph D, 82-2-2072-4875, hylee612@gmail.com

    Recruiting

  • Ajou Univ. Medical Center

    Suwon, Yeong-tong, 16499

    Jun-han Shin, MD,PhD, 82-31-219-5710, shinjh@ajou.ac.kr

    Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju, 26426

    Byung-Su Yoo, MD,PhD, 82-33-741-0908, yubs@yonsei.ac.kr

    Recruiting

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
CarVeDilol-SR (Slow Release), Carvedilol IR (Immediate Release)
Keywords
HFrEF, Carvedilol, Slow Release, NT-proBNP

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarVeDilol-SR (Slow Release)Drug

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

  • Carvedilol IR (Immediate Release)Drug

    patients will receive immediate release carvedilol (IR) twice daily

Study groups in NCT03209180
Study groupRoleWhat they receive
Carvedilol IR (Immediate Release)Active comparatorCarvedilol IR 3.125mg, 6.25mg, 12.5mg, 25mg twice daily p.o. for 6 months
Receives: Drug: Carvedilol IR (Immediate Release)
CarVeDilol-SR (Slow Release)ExperimentalCarVeDilol-SR 8mg, 16mg, 32mg, 64mg once daily p.o. for 6 months
Receives: Drug: CarVeDilol-SR (Slow Release)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NT-proBNP

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

    Measured: 6 months

Secondary outcomes (5)

  1. All-cause Death

    Difference in all-cause deaths between the groups during clinical follow-up

    Measured: 6 months

  2. Hospitalization

    Difference in hospitalization for heart failure between the groups during clinical follow-up

    Measured: 6 months

  3. Blood Pressure

    Difference in blood pressure change between the groups during clinical follow-up

    Measured: 6 months

  4. Dyspnea

    Differences in dyspnea measured with visual analogue scale between the groups during clinical follow-up

    Measured: 6 months

  5. Drug compliance

    Differences in drug compliance measured with 'pill-count' between the groups during clinical follow-up

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2017
  2. Study start27 Oct 2016
  3. Primary completion25 Jun 2018 (estimated)
  4. Study completion31 Dec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
PROBE and NON-INFERIORITY DESIGN for Slow Release CarVeDilol-SR to Rapid Release Carvedilol-IR
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03209180
Sponsor's protocol ID
CVDSR
Acronym
SLOW-HF
Status last verified
Jul 2017
First submitted
3 Jul 2017
Last updated
6 Jul 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35066737

  • 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.

    PubMed 29433525

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CarVeDilol-SR (Slow Release) and Carvedilol IR (Immediate Release) in people with Heart Failure With Reduced Ejection Fraction, run by Seoul National University Bundang Hospital at 13 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NT-proBNP (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03209180, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2017; AzTrials last refreshed its copy on 1 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in