NCT03892148

Brief Summary

The main objective of the study is to determine if a diuretic adaptation protocol in the decompensation of chronic heart failure is more effective but also safer than the current non-protocolized practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started May 2019

Typical duration for phase_4 heart-failure

Geographic Reach
1 country

9 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 22, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 27, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 17, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2023

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

3.7 years

First QC Date

February 22, 2019

Last Update Submit

January 27, 2026

Conditions

Heart FailureAcute Heart FailureChronic Heart Failure

Keywords

Heart FailureDiureticsDiuretic resistanceLoop diureticsFurosemide

Outcome Measures

Primary Outcomes (2)

  • Change in the serum creatinine level

    serum creatinine

    at 96 hours of admission

  • change in weight

    The weight will be measured in kilograms

    at 96 hours of admission

Secondary Outcomes (13)

  • Time of intravenous administration of diuretics

    at 1 month

  • severity of acute kidney injury during hospitalisation

    at 1 month

  • Severe Hypokaliemia

    at month

  • Number of rehospitalization for heart failure or kidney failure

    At 30 days after the date of randomisation

  • Mortality (all cause and heart failure)

    At 30 days after the date of randomisation

  • +8 more secondary outcomes

Study Arms (2)

Standard

ACTIVE COMPARATOR

Use of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician

Drug: FurosemideDrug: Hydrochlorothiazide

Protocol

EXPERIMENTAL

use of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network

Drug: FurosemideDrug: Hydrochlorothiazide

Interventions

FurosemideDRUG

Protocol for the use of diuretics

ProtocolStandard
HydrochlorothiazideDRUG

Protocol for the use of diuretics

ProtocolStandard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients hospitalized for chronic decompensated congestive heart failure without acute pulmonary edema and acute cardiac decompensation against a background of hypertensive crisis
  • covered under a social security program
  • with legal capacity to give voluntary informed consent to participate in the study

You may not qualify if:

  • First episode of decompensated congestive heart failure
  • Protocolized shock or hypotension (\<90 mmHg blood pressure) managed or requiring nitrovasodilators or non-invasive ventilation
  • One of the following cardiovascular pathologies: acute myocardial infarction / cardiac tamponade / aortic dissection / acute pulmonary embolism / heart transplant / ventricular assist device / acute pulmonary edema / hypertensive crisis
  • Generalized edema caused by cirrhosis or nephrotic syndrome
  • Requiring pleural or peritoneal tap for therapeutic purposes
  • Patient allergic or intolerant to furosemide and on long-term bumetanide use
  • Patient in dialysis or end-stage chronic kidney disease (CKD-EPI-calculated GFR \<15 mL/min/1.73m²) or acute kidney injury of known non-cardiac cause
  • Severe hypokalemia (\< 3 mmol/L) on admission
  • Patient who is pregnant, breastfeeding, or of childbearing age not on effective contraception
  • Adult patient safeguarded under court protection measures (guardianship, wardship, or judicial protection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Ch Annecy

Annecy, France

Location

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de GRENOBLE

Grenoble, France

Location

Ch Issoire

Issoire, France

Location

CH PUY

Le Puy-en-Velay, France

Location

Infirmerie Protestante de Lyon

Lyon, 69300, France

Location

Ch Lyon Sud

Lyon, France

Location

Ch Moulins

Moulins, France

Location

CH RIOM

Riom, France

Location

MeSH Terms

Conditions

Heart Failure

Interventions

FurosemideHydrochlorothiazide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfanilamidesSulfonamidesAmidesOrganic ChemicalsAniline CompoundsAminesSulfonesSulfur CompoundsChlorothiazideBenzothiadiazinesThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Guillaume CLERFOND

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2019

First Posted

March 27, 2019

Study Start

May 17, 2019

Primary Completion

January 16, 2023

Study Completion

January 16, 2023

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

FR(9)