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Randomization was stopped early because a significant beneficial effect of nutritional intervention was found in the interim analysis
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The purpose of this study is to determine whether a modification of the diet of malnourished patients admitted for heart failure is beneficial in term of mortality,hospitalizations and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional intervention | Active Comparator | It will last 6 months. Will be conducted by a physician nutrition specialist assisted by a technician in diet and nutrition. The first visit will take place during admission. The patient receives dietary advice and a customized diet designed to optimize energy intake and macro/micro-nutrients needs. |
|
| Care as usual | Placebo Comparator | The patients are referred to their cardiologyst and primary care physicians |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional intervention | Other | Modification of diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality and heart failure hospitalizations | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Juan de la Cruz | Úbeda | Jaen | 23400 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21652135 | Background | Bonilla-Palomas JL, Gamez-Lopez AL, Anguita-Sanchez MP, Castillo-Dominguez JC, Garcia-Fuertes D, Crespin-Crespin M, Lopez-Granados A, Suarez de Lezo J. [Impact of malnutrition on long-term mortality in hospitalized patients with heart failure]. Rev Esp Cardiol. 2011 Sep;64(9):752-8. doi: 10.1016/j.recesp.2011.03.009. Epub 2011 Jun 8. Spanish. | |
| 34931696 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Baldwin C, de van der Schueren MA, Kruizenga HM, Weekes CE. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002008. doi: 10.1002/14651858.CD002008.pub5. |
| 28262195 | Derived | Bonilla-Palomas JL, Gamez-Lopez AL, Castillo-Dominguez JC, Moreno-Conde M, Lopez Ibanez MC, Alhambra Exposito R, Ramiro Ortega E, Anguita-Sanchez MP, Villar-Raez A. Nutritional Intervention in Malnourished Hospitalized Patients with Heart Failure. Arch Med Res. 2016 Oct;47(7):535-540. doi: 10.1016/j.arcmed.2016.11.005. |