Protocol of Diuretics Use in Congestive Therapy in Heart Failure
- Conditions
- Heart FailureChronic Heart FailureAcute Heart Failure
- Interventions
- Registration Number
- NCT03892148
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Furosemide Use of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician Standard Hydrochlorothiazide Use of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician Protocol Furosemide use of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network Protocol Hydrochlorothiazide use of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network
- Primary Outcome Measures
Name Time Method Change in the serum creatinine level at 96 hours of admission serum creatinine
change in weight at 96 hours of admission The weight will be measured in kilograms
- Secondary Outcome Measures
Name Time Method Blood chemistry month 1 NT-proBNP or BNP (as available)
Dose of diuretics 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.
Time of intravenous administration of diuretics at 1 month Length of time of intravenous administration of diuretics in days
severity of acute kidney injury during hospitalisation at 1 month Acute kidney injury requiring interruption of treatment
Severe Hypokaliemia at month Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.
Number of rehospitalization for heart failure or kidney failure At 30 days after the date of randomisation Number of rehospitalization for heart failure or kidney failure
Mortality (all cause and heart failure) At 30 days after the date of randomisation Number of death of participants
Description and comparison of global cost between the two groups At 30 days after the date of randomisation Description and comparison of global cost between the two groups
Estimated plasma volume change At 30 days after the date of randomisation Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula
change in bodyweight at 96 hours after admission of patient The weight will be measured in kilograms
Blood chemistry (serum creatinine) month 1 serum creatinine
Blood chemistry (glomerular filtration rate) month 1 glomerular filtration rate (GFR) estimated using the CKD-EPI equation
Blood chemistry (plasma volume estimated) month 1 plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)
Trial Locations
- Locations (9)
Ch Annecy
🇫🇷Annecy, France
CH PUY
🇫🇷Le Puy-en-Velay, France
CHU de GRENOBLE
🇫🇷Grenoble, France
Chu Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
Ch Issoire
🇫🇷Issoire, France
CH RIOM
🇫🇷Riom, France
Ch Lyon Sud
🇫🇷Lyon, France
Infirmerie Protestante de Lyon
🇫🇷Lyon, France
Ch Moulins
🇫🇷Moulins, France