Nutritional Improvement in Chronic Heart Failure Patients

NCT ID: NCT02599935

Last Updated: 2015-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-09-30

Brief Summary

To assess the effect over the nutritional status in patients who are malnourished with chronic heart failure, of an educational intervention and the provision of nutritional supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12 months

Detailed Description

Randomized clinical trial with blinded evaluators. (The evaluators will not know the group the patients are assigned. Blinded evaluators are no responsible for randomization and intervention once the patients have been randomized). Patients will be recruited from the cardiology inpatient unit of tertiary hospital, before discharge. Patients will be divided in two groups randomly:

In one arm will be held a double intervention:

• A structured educational intervention oriented to the patient and primary caregiver, with respect to dietary habits, highly energetic and healthy food, the frequency and manner of eating, exercise and programming breaks.
• supplementation with dietary supplements, distinguishing one type of product or another, depending on whether the subject to study: diabetes and or kidney failure.

In the other arm of the study was carried out regular interventions

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

educational intervention and supplements

structured educational intervention and dietary supplements

Group Type: EXPERIMENTAL

Hypercaloric beverages

Intervention Type: DIETARY_SUPPLEMENT

Nutritional supplement: Hypercaloric beverages

educational structured counseling

Intervention Type: OTHER

Nutritional counseling leaded to patient and caregivers

usual interventions

Usual treatment without nutritional supplements or structured assessment

Group Type: ACTIVE_COMPARATOR

standard treatment

Intervention Type: OTHER

No other than standard treatment

Interventions

Hypercaloric beverages

Nutritional supplement: Hypercaloric beverages

Intervention Type: DIETARY_SUPPLEMENT

standard treatment

No other than standard treatment

Intervention Type: OTHER

educational structured counseling

Nutritional counseling leaded to patient and caregivers

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• adult patients with the diagnosis of heart failure: who inadvertently lost at least 5% of their "dry weight" in the last six months and / or moderately or severely malnourished according to the GSA and / or at risk or malnourished according to Mini Nutritional Assessment.
• Willing to participate by accepting and signing an informed consent.
• On treatment with inhibitors of angiotensin converting enzyme (ACE) inhibitors and / or antagonists of angiotensin II receptors (ARBs) and / or beta blockers.

Exclusion Criteria

• Concurrent active cancer diagnosed.
• Previous history Dementia or severe cognitive impairment.
• Participation in another clinical trial simultaneously.
• Social or health condition that makes the patient impossible to follow the treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Luis Guerra

OTHER

Sponsor Role: lead

Responsible Party

Luis Guerra

Nurse

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Luis Guerra, Nurse

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Maranon

Locations

Servicio de Nefrología Hospital General universitario Gregorio Maranon

Madrid, Madrid, Spain

Countries

Spain

Other Identifiers

PI11/02428

Identifier Type: -

Identifier Source: org_study_id