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Malnutrition is common in patients with heart failure (HF) and is associated with a worse prognosis.
However, there is little information on the impact of nutritional intervention in malnourished patients with heart failure. Therefore, the aim of our study is to evaluate whether a specific nutritional intervention has an impact on mortality and hospitalizations, quality of life, nutritional status, and functional capacity in patient with heart failure and malnutrition.
A high prevalence of malnutrition has been reported in hospitalized patients with acute heart failure and some studies suggest that personalized treatments or interventions on nutritional status could improve prognosis in these patients. Previous studies have shown that malnutrition is an independent factor associated with worse prognosis not only in hospitalized patients with decompensated HF but also in patients with chronic stable HF. In this sense, it has been postulated that nutritional intervention in malnourished patients with HF could have some prognostic benefit. However, there are very few data published in the literature that have assessed the nutritional status and the benefit of a nutritional intervention in stable ambulatory patients with chronic HF.
Therefore, the aim of this study was to evaluate whether the application of an educational and nutritional intervention in malnourished patients with heart failure improves prognosis, nutritional status, functional capacity and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Control arm: Who received the usual practice. |
|
| Intervention | Experimental | Intervention arm: Who received an individualized diet, educational intervention with/without nutritional supplements depending on the degree of malnutrition plus usual practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutritional and educational intervention | Combination Product | individualized diet plus educational intervention with/without nutritional supplements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF) | [ Time to the first event of adjudicated cardiovascular (CV) death or adjudicated hospitalisation for heart failure (HHF). The incidence rate per 100 patient years (100 * number of patients with event /time at risk [years]) is presented. With time at risk [year] calculated as: Sum of time at risk [days] over all patients in a treatment group / 365.25. Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier. Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk.](streamdown:incomplete-link) | From randomisation until completion 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the impact of the intervention on nutritional status. | Nutritional status will be established according to the Mini Nutritional Assesment (MNA) score, which includes 18 items divided into 4 groups: anthropometry, general condition, dietary aspects and subjective assessment. The nutritional status is classified into 3 groups according to the score obtained: well nourished (equal to or greater than 24 points), at risk of malnutrition (17-23.5 points) and malnourished (less than 17 points), and other biochemical and anthropometric parameters will be collected to complete the nutritional study |
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Inclusion Criteria:
Exclusion Criteria:
*Dementia or severe cognitive impairment.
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| Name | Affiliation | Role |
|---|---|---|
| Carolina Ortiz Cortés | Carolina Ortiz Cortés | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San Pedro de Alcántara | Cáceres | 10003 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2022 | Aug 30, 2022 | SAP_000.pdf |
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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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| standard practice | Other | The patients received the usual treatment and clinical practice |
|
| baseline and 52 weeks |
| To assess the impact of the intervention on quality of life | Change From Baseline in KCCQ (Kansas City Cardiomyopathy Questionnaire) Clinical Summary Score at Week 52. The KCCQ is a 23-item self-administered questionnaire designed to evaluate physical limitations, symptoms (frequency, severity, and changes over time), social limitations, selfefficacy, and quality of life in patients with Heart Failure. The KCCQ-clinical summary score comprises the following domains: Symptom frequency, symptom burden and physical limitation. The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status. For patients who died, a worst score (score of 0) is imputed at all subsequent scheduled visits after the date of death. | baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52 |
| To assess the impact of the intervention on be assessed by means of the 6-minute test. | Functional capacity is assessed with the 6-minute test. It consists of measuring the maximum distance that the patient is able to walk in 6 minutes, in a short corridor, simultaneously evaluating the heart rate, oxygen saturation and the degree of dyspnea. | baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52 |