Protocol of Diuretics Use in Congestive Therapy in Heart Failure

Last updated: April 13, 2021
Sponsor: University Hospital, Clermont-Ferrand
Overall Status: Active - Recruiting

Phase

4

Condition

Heart Failure

Chest Pain

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT03892148
CHU-428
2018-A02971-54
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients hospitalized for chronic decompensated congestive heart failure withoutacute pulmonary edema and acute cardiac decompensation against a background ofhypertensive crisis
  • covered under a social security program
  • with legal capacity to give voluntary informed consent to participate in the study

Exclusion

Exclusion Criteria:

  • First episode of decompensated congestive heart failure
  • Protocolized shock or hypotension (<90 mmHg blood pressure) managed or requiringnitrovasodilators or non-invasive ventilation
  • One of the following cardiovascular pathologies: acute myocardial infarction / cardiactamponade / aortic dissection / acute pulmonary embolism / heart transplant /ventricular assist device / acute pulmonary edema / hypertensive crisis
  • More than 12h of intravenous diuretics administered prior to inclusion
  • 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 <15mL/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 effectivecontraception
  • Adult patient safeguarded under court protection measures (guardianship, wardship, orjudicial protection)

Study Design

Total Participants: 300
Study Start date:
May 17, 2019
Estimated Completion Date:
December 31, 2021

Study Description

Diuretics are the main treatment for congestive decompensation of chronic heart failure. For symptomatic purposes, the goal is to decrease the volume overload. In these patients, loop diuretics are used in high doses, sometimes in combination with other classes of diuretics such as thiazides to achieve synergistic, faster and more effective action, and to combat diuretic's resistance. This use, well known to cardiologists and based on a rich pharmacology, more than 40 years old, lacks robust scientific data in real life. Current studies are mainly based on patients with renal insufficiency or limited to cardio-renal syndrome. The CARRESS-H study in 2012 is one of them. The protocol for the use of diuretics from this study was included in 2017 as a benchmark in a publication of the NEJM. It therefore seems necessary to consider the exercise of this protocol in the management of the decompensation of chronic cardiac heart failure. There is, to the investigator's knowledge, no similar study to test this protocol as a "real life" exercise.

Connect with a study center

  • Ch Annecy

    Annecy,
    France

    Active - Recruiting

  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • CHU de GRENOBLE

    Grenoble,
    France

    Active - Recruiting

  • Ch Issoire

    Issoire,
    France

    Active - Recruiting

  • CH PUY

    Le Puy-en-Velay,
    France

    Active - Recruiting

  • Ch Lyon Sud

    Lyon,
    France

    Active - Recruiting

  • Infirmerie Protestante de Lyon

    Lyon, 69300
    France

    Active - Recruiting

  • Ch Montlucon

    Montluçon,
    France

    Site Not Available

  • Ch Moulins

    Moulins,
    France

    Active - Recruiting

  • CH RIOM

    Riom,
    France

    Active - Recruiting

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