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Completed

NCT Number: NCT03892148

Protocol of Diuretics Use in Congestive Therapy in Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ch Annecy, Annecy, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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 <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)

Treatment and study plan

Furosemide

Drug

Protocol for the use of diuretics

Hydrochlorothiazide

Drug

Protocol for the use of diuretics

Primary outcomes

  1. Change in the serum creatinine level

    Time frame: at 96 hours of admission

    serum creatinine

  2. change in weight

    Time frame: at 96 hours of admission

    The weight will be measured in kilograms

Secondary outcomes

  1. Time of intravenous administration of diuretics

    Time frame: at 1 month

    Length of time of intravenous administration of diuretics in days

  2. severity of acute kidney injury during hospitalisation

    Time frame: at 1 month

    Acute kidney injury requiring interruption of treatment

  3. Severe Hypokaliemia

    Time frame: at month

    Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.

  4. Number of rehospitalization for heart failure or kidney failure

    Time frame: At 30 days after the date of randomisation

    Number of rehospitalization for heart failure or kidney failure

  5. Mortality (all cause and heart failure)

    Time frame: At 30 days after the date of randomisation

    Number of death of participants

  6. Dose of diuretics

    Time frame: At 30 days after the date of randomisation

    Comparison of diuretics dose of Furosemide and/or Thiazid diuretic. The dose will be measured on milligrams per day.

  7. Description and comparison of global cost between the two groups

    Time frame: At 30 days after the date of randomisation

    Description and comparison of global cost between the two groups

  8. Estimated plasma volume change

    Time frame: At 30 days after the date of randomisation

    Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula

  9. change in bodyweight

    Time frame: at 96 hours after admission of patient

    The weight will be measured in kilograms

  10. Blood chemistry (serum creatinine)

    Time frame: month 1

    serum creatinine

  11. Blood chemistry (glomerular filtration rate)

    Time frame: month 1

    glomerular filtration rate (GFR) estimated using the CKD-EPI equation

  12. Blood chemistry

    Time frame: month 1

    NT-proBNP or BNP (as available)

  13. Blood chemistry (plasma volume estimated)

    Time frame: month 1

    plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • CH Annecy Genevois
  • CH Issoire
  • CH Moulins-Yzeure
  • CH Puy en Velay
  • CH Riom
  • Hospices Civils de Lyon
  • Hôpital de la Croix-Rousse
  • Infirmerie Protestante de Lyon
  • University Hospital, Grenoble

Registry information

Official study title

Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation

Acronym: ProDUCT-HF

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2019
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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