Prognostic and Clinical Impact of a Nutritional Intervention in Patients With Chronic Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients older than 18 years with a confirmed diagnosis of HF according to current criteria established by clinical practice guidelines and who present left ventricular dysfunction documented by echocardiography (LVEF less than 40%).
- •Patients with clinical stability in the last 6 months defined as no admissions or decompensations in the last 6 months.
- •Patients with malnutrition or at risk of malnutrition according to criteria established by the Mini Nutritional Assessment score (see attached).
- •Patients who agree to participate in the study by signing the written informed consent after receiving verbal and written information about the study.
Exclusion Criteria
- •*Dementia or severe cognitive impairment.
- •Dialysis.
- •Already receiving nutritional supplements.
- •Known concomitant oncologic process or other concomitant disease with life expectancy of less than 1 year.
- •Pregnant women.
- •Participation in another clinical trial concurrently.
Outcomes
Primary Outcomes
Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF)
Time Frame: From randomisation until completion 365 days
\[ 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.
Secondary Outcomes
- To assess the impact of the intervention on nutritional status.(baseline and 52 weeks)
- To assess the impact of the intervention on quality of life(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.(baseline and 52 weeks. Assessed at baseline, week 12, week 26 and week 52)
Investigators
Carolina Ortiz Cortes
Doctor
Universidad de Extremadura