NCT02689180

Brief Summary

The ReBIC-1 trial was designed to evaluate the potential clinical risks and benefits of withdrawing furosemide use in stable, apparently euvolemic, chronic HF outpatients in a multicentric double-blinded randomized clinical trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P50-P75 for phase_3 heart-failure

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

2 years

First QC Date

November 25, 2015

Last Update Submit

February 22, 2016

Conditions

Heart Failure

Keywords

heart failurediureticsfurosemide

Outcome Measures

Primary Outcomes (2)

  • Feasibility of furosemide withdraw - proportion of patients maintained without diuretic during follow-up

    Proportion of patients maintained without diuretic during follow-up

    90 days

  • Safety of furosemide withdraw - dyspnea score variation assessed by a visual analog scale

    Dyspnea score variation assessed by a visual analog scale after randomization

    90 days

Secondary Outcomes (5)

  • Variation of plasmatic levels of natriuretic peptides

    Baseline and 90 days

  • Variation in meters walked assessed by the 6 minute walking test

    Baseline and 90 days

  • Variation in renal function

    Baseline, 15, 45 and 90 days

  • Variation on the Clinical Congestion Score

    Baseline, 15, 45 and 90 days

  • Clinical composite endpoints

    90 days

Study Arms (2)

Withdraw of furosemide

PLACEBO COMPARATOR

Withdraw of of 40 or 80 mg of furosemide per day

Drug: Placebo

Maintenance of furosemide

ACTIVE COMPARATOR

Maintenance of 40 or 80 mg of furosemide per day

Drug: Furosemide

Interventions

PlaceboDRUG

Replacement of furosemide by placebo

Withdraw of furosemide
FurosemideDRUG

Maintenance of furosemide on usual doses

Maintenance of furosemide

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
The ReBIC-1 study will enroll HF outpatients that fulfill the following criteria: 1. age equal or greater than 18 year-old; 2. New York Heart Association functional class I or II; 3. Left Ventricular Ejection Fraction ≤ 45% by transthoracic two-dimensional echocardiography performed within 3 months before the screening visit; 4. no previous HF related hospitalization or visit to emergency room within 6 months before the screening visit; 5. treatment with a stable dose of furosemide (40 or 80 mg per day) for at least 6 months before the screening visit; 6. plasma potassium \< 5 mg/dl within 3 months before the screening visit; 7. optimal HF treatment with an angiotensin converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) and beta-blockers, unless contraindicated or not tolerated. The ReBIC-1 study will exclude HF outpatients that fulfill the following criteria: 1. a clinical congestion score (CCS) \> 5 points; 2. prior acute coronary syndrome, stroke or myocardial revascularization within 3 months before the screening visit; 3. any severe valve heart disease (aortic, mitral or tricuspid); 4. severe pulmonary disease (asthma, emphysema or fibrosis); 5. severe hepatic failure or cirrhosis; 6. end-stage acute or chronic renal disease (on hemodialysis); 7. malignancy on active treatment; 8. congenital heart disease; 9. participation on any other interventional clinical research; 10. inability to understand and sign informed consent.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Division, Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (8)

  • Lip GY, Gibbs CR, Beevers DG. ABC of heart failure: aetiology. BMJ. 2000 Jan 8;320(7227):104-7. doi: 10.1136/bmj.320.7227.104. No abstract available.

    PMID: 10625270BACKGROUND

  • McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.

    PMID: 22611136BACKGROUND

  • WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.

    PMID: 23741058BACKGROUND

  • Cowley AJ, Stainer K, Wynne RD, Rowley JM, Hampton JR. Symptomatic assessment of patients with heart failure: double-blind comparison of increasing doses of diuretics and captopril in moderate heart failure. Lancet. 1986 Oct 4;2(8510):770-2. doi: 10.1016/s0140-6736(86)90298-9.

    PMID: 2876233BACKGROUND

  • Eshaghian S, Horwich TB, Fonarow GC. Relation of loop diuretic dose to mortality in advanced heart failure. Am J Cardiol. 2006 Jun 15;97(12):1759-64. doi: 10.1016/j.amjcard.2005.12.072. Epub 2006 Apr 27.

    PMID: 16765130BACKGROUND

  • Mielniczuk LM, Tsang SW, Desai AS, Nohria A, Lewis EF, Fang JC, Baughman KL, Stevenson LW, Givertz MM. The association between high-dose diuretics and clinical stability in ambulatory chronic heart failure patients. J Card Fail. 2008 Jun;14(5):388-93. doi: 10.1016/j.cardfail.2008.01.015. Epub 2008 May 27.

    PMID: 18514930BACKGROUND

  • Blacher M, Zimerman A, Engster PHB, Grespan E, Polanczyk CA, Rover MM, Neto JAF, Danzmann LC, Bertoldi EG, Simoes MV, Beck-da-Silva L, Biolo A, Rohde LE. Revisiting heart failure assessment based on objective measures in NYHA functional classes I and II. Heart. 2021 Sep;107(18):1487-1492. doi: 10.1136/heartjnl-2020-317984. Epub 2020 Dec 23.

    PMID: 33361353DERIVED

  • Rohde LE, Rover MM, Figueiredo Neto JA, Danzmann LC, Bertoldi EG, Simoes MV, Silvestre OM, Ribeiro ALP, Moura LZ, Beck-da-Silva L, Prado D, Sant'Anna RT, Bridi LH, Zimerman A, Raupp da Rosa P, Biolo A. Short-term diuretic withdrawal in stable outpatients with mild heart failure and no fluid retention receiving optimal therapy: a double-blind, multicentre, randomized trial. Eur Heart J. 2019 Nov 21;40(44):3605-3612. doi: 10.1093/eurheartj/ehz554.

    PMID: 31424503DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur Compounds

Study Officials

  • Luis Eduardo Rohde, PHD

    Hospital de Clínicas de Porto Alegre

    STUDY CHAIR

Central Study Contacts

Luis Eduardo Rohde, PHD

CONTACT

555133598843lerohde@gmail.com

Priscila Raupp da Rosa, MD

CONTACT

555199127137raupp.priscilamd@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

February 23, 2016

Study Start

May 1, 2015

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

February 23, 2016

Record last verified: 2016-02

Locations

BR(1)