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Heart Failure With Reduced Ejection Fraction HFrEFPhase 4NCT05179070

Effect of Carvedilol Rapid Up-Titration in Patients With Heart Failure With Reduced Ejection Fraction

A Phase 4 study testing Carvedilol in people with Heart Failure With Reduced Ejection Fraction HFrEF, run by Universitas Sebelas Maret at 1 site in Indonesia.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Guidelines-directed medical therapy has improved dramatically outcomes in heart failure with reduced ejection fraction (HFrEF) patients. Beta-blockers have the most beneficial effects on all caused mortality and rehospitalization on HFrEF, but unfortunately, since the discovery of beta-blocker therapy in HFrEF, there… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Carvedilol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteIndonesia
Study dates
10 Sep 2021to 30 Mar 2022
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute heart failure patient with reduced ejection fraction in Universitas Sebelas Maret Hospital with naive betablocker therapy
  • Age >18 years old
  • Initial Heart Rate > 50 bpm

Who cannot join

  • Cardiogenic Shock
  • Septicaemia
  • High degree AV Block or on pace maker
  • History of beta blocker intolerance
  • Reactive Pulmonary disease
  • Severe Peripheral artery disease
  • Creatinine level > 2.5 mg/dl
  • Potassium serum >5 mmol/L

Trial locations and contacts

1 site in 1 country.

Habibie Arifianto, MD contact

81215801707 ext. +62

habibie.arifianto@staff.uns.ac.id

Auliya B Nuriana, MD contact

87887824659 ext. +62

auliyabintan13@gmail.com

Indonesia1 site, 1 recruiting

  • Universitas Sebelas Maret Hospital

    Sukoharjo, Central of Java, 57161

    Habibie Arifianto, MD, 81215801707 ext. +62, habibie.arifianto@staff.uns.ac.id

    Recruiting

Other trials in Indonesia

About this study

Official title: The Effect of Carvedilol Rapid Up-Titration in Patients With Heart Failure With Reduced Ejection Fraction (Biomolecular and Clinical Study on IL-6, TNF-α, NT-ProBNP, MDA, LVEF, 6MWT, and KCCQ)

Guidelines-directed medical therapy has improved dramatically outcomes in heart failure with reduced ejection fraction (HFrEF) patients. Beta-blockers have the most beneficial effects on all caused mortality and rehospitalization on HFrEF, but unfortunately, since the discovery of beta-blocker therapy in HFrEF, there was no change in the way of titration, start low go slow, which resulted in difficulties in reaching optimal doses for some patients.

Read the detailed description

This study is a randomized controlled trial, single-center study in HFrEF patients, that held in Universitas Sebelas Maret Hospital, Central Java, Indonesia. The investigators divided 26 HFrEF patients consecutively into two groups, the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively. And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks. Every patient will be checked for IL-6, TNF-α, NT-ProBNP, MDA, left ventricular Ejection Fraction, six minutes walking test, and Kansas City Cardiomyopathy Questionnaire on day 1, pre-discharge, and one month after hospitalization. The study was approved by the university ethics committee. The clinical parameters evaluated at admission were analyzed using variable comparative with Shapiro Wilk or one-way ANOVA, with three intervals analysis using repeated ANOVA (p<0.05).

Being tested
Carvedilol
Keywords
HFrEF, Carvedilol, Rapid UpTitration, Heart Failure
Medical subject headings
Heart Failure

What participants receive

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

  • CarvedilolDrug

    Also called Vblock

    the first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively. And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks

Study groups in NCT05179070
Study groupRoleWhat they receive
UpTitrationExperimentalthe first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively
Receives: Drug: Carvedilol
ControlActive comparatorAnd the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks
Receives: Drug: Carvedilol

What is being measured

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

  1. Improvements of Biomolecular Parameters

    IL-6 in pg/ml, TNF-α in pg/ml, NT-ProBNP in pg/ml, Malondyaldehide nmol/ml

    Measured: 1 month

  2. Improvements of Clinical Parameters

    Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition) and 6 Minutes Walking Test in meters

    Measured: 1 month

  3. Improvements of Echocardiography Parameters

    LVEF

    Measured: 1 month

Secondary outcomes (1)

  1. Major Adverse Cardiac Events

    All cause cardiac rehospitalization

    Measured: 1 month

Timeline

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

  1. First posted5 Jan 2022
  2. Study start10 Sep 2021
  3. Primary completion28 Feb 2022 (estimated)
  4. Study completion30 Mar 2022 (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
Devided into 2 groups. The first is the rapid up-titration group, which will get carvedilol up-titration every day, 3.125mg twice daily on the first day, 6.125mg twice daily on the second day, 12.5mg twice daily on the third day and 25mg twice daily on the fourth day consecutively. And the second group will have carvedilol titration according to established guidelines on Heart Failure, start 3.125mg twice daily, and up titrated every 2 weeks
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05179070
Sponsor's protocol ID
001/02/08/90
Status last verified
Dec 2021
First submitted
17 Nov 2021
Last updated
5 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study purpose is to obtain a doctoral degree, there was no sponsorship during this study therefore the IPD cannot be shared

Publications

  • Wolfe NK, Mitchell JD, Brown DL. The independent reduction in mortality associated with guideline-directed medical therapy in patients with coronary artery disease and heart failure with reduced ejection fraction. Eur Heart J Qual Care Clin Outcomes. 2021 Jul 21;7(4):416-421. doi: 10.1093/ehjqcco/qcaa032.

    PubMed 32324852

  • Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28. No abstract available.

    PubMed 28461007

  • Martinez-Selles M, Datino T, Alhama M, Barrueco N, Castillo I, Fernandez-Aviles F. Rapid carvedilol up-titration in hospitalized patients with left ventricular systolic dysfunction--data from the Carvedilol in Hospital: Up-titration Limits after Acute Patients Admission registry. J Cardiovasc Med (Hagerstown). 2010 May;11(5):352-8. doi: 10.2459/JCM.0b013e328334f48b.

    PubMed 20154635

  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

    PubMed 27207191

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Carvedilol in people with Heart Failure With Reduced Ejection Fraction HFrEF, run by Universitas Sebelas Maret at 1 site in Indonesia.

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 3 inclusion and 8 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. 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?

Contact Habibie Arifianto, MD (81215801707 ext. +62, habibie.arifianto@staff.uns.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvements of Biomolecular Parameters (time frame: 1 month). The study lists 3 primary outcomes in all. 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 NCT05179070, which also lists 4 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 5 Jan 2022.

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