Acute Heart Failure, Chronic Heart Failure, Heart Failure
Conditions
Keywords
Heart Failure, Diuretics, Diuretic resistance, Loop diuretics, Furosemide
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.
Interventions
DRUGFurosemide
Protocol for the use of diuretics
DRUGHydrochlorothiazide
Protocol for the use of diuretics
Sponsors
University Hospital, Clermont-Ferrand
University Hospital, Grenoble
Hospices Civils de Lyon
Hôpital de la Croix-Rousse
CH Puy en Velay
CH Moulins-Yzeure
CH Riom
Infirmerie Protestante de Lyon
CH Issoire
CH Annecy Genevois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 | month 1 | NT-proBNP or BNP (as available) |
| Blood chemistry (plasma volume estimated) | month 1 | plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORGuillaume CLERFOND
University Hospital, Clermont-Ferrand
Outcome results
None listed