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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
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The purpose of this study is to determine the effect of fluid restriction and the neurohormonal mechanisms in the development of hyponatremia in patients with congestive heart failure and hyponatremia. The hypothesis is that strict fluid restriction leads to a larger increase in plasma sodium than standard treatment in patients with decompensated heart failure associated with hyponatremia. A secondary hypothesis is that the neurohormonal change is greater in patients treated with strict fluid restriction versus standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strict fluid restriction < 1 L/day | Other | 20 patients will be randomized to strict fluid restriction < 1 L/day |
|
| Moderate fluid restriction < 2.5 L/day | Other | 20 patients will be randomized to moderate fluid restriction < 2.5 L/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid restriction | Other | Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma sodium from day 1 to day 4: - Normalization of plasma sodium or - A significant change in plasma sodium of a minimum of 5 mmol/L from baseline to day 4 | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma vasopressin and copeptin | 5 days | |
| Change in blood pressure, heart rate, weight and oedemas | 5 days | |
| Change in dyspnoea assessed by the patient |
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Inclusion Criteria:
At least two of the following signs of decompensated heart failure and fluid retention:
And
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Finn Gustafsson, MD, PhD, DMSci | Contact | 004535459743 | finn.gustafsson@regionh.dk | |
| Louise Balling, MD | Contact | 004523451679 | louise.balling@dadlnet.dk |
| Name | Affiliation | Role |
|---|---|---|
| Finn Gustafsson, MD, PhD, DMSci | Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | 1718 | Denmark |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D007010 | Hyponatremia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
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| 5 days |
| Number of days until clinical stability | 5 days |
| The correlation between hospitalization time and plasma sodium | 5 days |
| Correlation between fluid restriction and change in kidney function | 5 days |
| Patient assessment of fluid restriction | 5 days |
| Patient compliance to fluid restriction | 5 days |
| Bispebjerg Hospital | Recruiting | Copenhagen | 2400 | Denmark |
|
| D009750 |
| Nutritional and Metabolic Diseases |