Informations générales (source: ClinicalTrials.gov)
Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation (ProDUCT-HF)
Interventional
Phase 4
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
mai 2019
décembre 2021
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Ch Annecy - Annecy - France | Contact (sur clinicalTrials) | ||||
| Ch Issoire - Issoire - France | Contact (sur clinicalTrials) | ||||
| Ch Lyon Sud - Lyon - France | Contact (sur clinicalTrials) | ||||
| CH PUY - Le Puy-en-Velay - France | Contact (sur clinicalTrials) | ||||
| Chu Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Lise LACLAUTRE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ch Moulins - Moulins - France | Contact (sur clinicalTrials) | ||||
| CH RIOM - Riom - France | Contact (sur clinicalTrials) | ||||
| CHU de GRENOBLE - Grenoble - France | Contact (sur clinicalTrials) | ||||
| Infirmerie Protestante de Lyon - 69300 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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)