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| ID | Type | Description | Link |
|---|---|---|---|
| SECAINC-INV-ICC 23/04 | Other Identifier | SOCIEDAD ESPAÑOLA DE CARDIOLOGIA |
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This is a randomized, controlled, open-label, prospective, multicentre clinical trial designed to assess the effects of a nutritional intervention on morbidity and mortality in patients with chronic heart failure.
Through a simple 1:1 randomization process, patients will be assigned to the control group or the intervention group. Patients in the intervention group will undergo an individualised nutritional intervention program consisting of 3 pillars: diet optimization, specific recommendations ,and nutritional supplementation if nutritional targets are not achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NUTRITIONAL INTERVENTION | Experimental |
| |
| CONTROL | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTS | Dietary Supplement | Nutritional intervention (diet, dietetic recommendations and/or supplements). Participants will receive specific recommendations about diet, energetic dietetic supplementation, oral nutritional supplements, exercise... The "Nutrition Team" (formed by cardiologists, dieticians, nurses...) will closely monitor patients with periodic visits and reassessment of nutritional status and compliance with recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| COMBINED EVENT | Time to the combined event of all-cause mortality or admission for heart failure at 6 months | 6 MONTHS |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 6-month cardiovascular mortality | 6 MONTHS | |
| Time to all-cause admission at 6 months | 6 MONTHS | |
| Changes in quality of life at 3 and 6 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JOSE ANGEL PEREZ-RIVERA | Contact | +34947281800 | 35756 | JANGEL.PEREZRIVERA@GMAIL.COM |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Burgos | Recruiting | Burgos | Spain |
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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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| ID | Term |
|---|---|
| D015444 | Exercise |
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| CONTROL | Dietary Supplement | Standard treatment (usual recommendations in patients with heart failure) |
|
Changes in the scores of Minnesota living with heart failure questionnaire |
| 6 MONTHS |
| Changes in nutritional status at 3 and 6 months post intervention | Changes in the scores of Mini Nutritional Assessment Short Form | 6 MONTHS |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |