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The aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (Body Composition Monitor-BCM) in patient with acute decompensated heart failure would improve the diuretic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCM group | Experimental | The patients are measured by Body Composition Monitor (BCM) and both the patient and the physician know the results and adjust the diuretic therapy accordingly. |
|
| Control group | Placebo Comparator | The patients are measured by Body Composition Monitor (BCM) but neither the patient nor the physician know the results, the physician adjusts the diuretic therapy as usual, according to the protocols. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Body Composition Monitor (BCM) | Device | In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-hospitalization rate | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Measured by validated questionnaire | 3 months |
| Renal function decline | Measured by estimated glomerular filtration rate (ml/min/1.73m2) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Studinger, MD, PhD | First Department of Medicine, Semmelweis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Department of Medicine, Semmelweis University | Budapest | 1083 | Hungary |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004487 | Edema |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 3 months |