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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A02971-54 | Other Identifier | 2018-A02971-54 |
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| Name | Class |
|---|---|
| University Hospital, Grenoble | OTHER |
| Hospices Civils de Lyon | OTHER |
| Hôpital de la Croix-Rousse | OTHER |
| CH Puy en Velay |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | Active Comparator | Use of loop diuretics and thiazide diuretics leaves to the discretion of the responsible physician |
|
| Protocol | Experimental | use of loop diuretics and thiazide diuretics according to the CARRESS-HF protocol developed by the Heart Failure Network |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide | Drug | Protocol for the use of diuretics |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the serum creatinine level | serum creatinine | at 96 hours of admission |
| change in weight | The weight will be measured in kilograms | at 96 hours of admission |
| Measure | Description | Time Frame |
|---|---|---|
| Time of intravenous administration of diuretics | Length of time of intravenous administration of diuretics in days | at 1 month |
| severity of acute kidney injury during hospitalisation | Acute kidney injury requiring interruption of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillaume CLERFOND | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Annecy | Annecy | France | ||||
| Chu Clermont-Ferrand |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| UNKNOWN |
| CH Moulins-Yzeure | UNKNOWN |
| CH Riom | UNKNOWN |
| Infirmerie Protestante de Lyon | OTHER |
| CH Issoire | UNKNOWN |
| CH Annecy Genevois | OTHER |
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| Hydrochlorothiazide |
| Drug |
Protocol for the use of diuretics |
|
| at 1 month |
| Severe Hypokaliemia | Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care. | at month |
| Number of rehospitalization for heart failure or kidney failure | Number of rehospitalization for heart failure or kidney failure | At 30 days after the date of randomisation |
| Mortality (all cause and heart failure) | Number of death of participants | At 30 days after the date of randomisation |
| Dose of diuretics | Comparison of diuretics dose of Furosemide and/or Thiazid diuretic. The dose will be measured on milligrams per day. | At 30 days after the date of randomisation |
| Description and comparison of global cost between the two groups | Description and comparison of global cost between the two groups | At 30 days after the date of randomisation |
| Estimated plasma volume change | Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula | At 30 days after the date of randomisation |
| change in bodyweight | The weight will be measured in kilograms | at 96 hours after admission of patient |
| Blood chemistry (serum creatinine) | serum creatinine | month 1 |
| Blood chemistry (glomerular filtration rate) | glomerular filtration rate (GFR) estimated using the CKD-EPI equation | month 1 |
| Blood chemistry | NT-proBNP or BNP (as available) | month 1 |
| Blood chemistry (plasma volume estimated) | plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht) | month 1 |
| Clermont-Ferrand |
| 63003 |
| France |
| CHU de GRENOBLE | Grenoble | France |
| Ch Issoire | Issoire | France |
| CH PUY | Le Puy-en-Velay | France |
| Infirmerie Protestante de Lyon | Lyon | 69300 | France |
| Ch Lyon Sud | Lyon | France |
| Ch Moulins | Moulins | France |
| CH RIOM | Riom | France |
| D000814 |
| Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |