NCT02599935

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
Last Updated

November 9, 2015

Status Verified

November 1, 2015

Enrollment Period

4 years

First QC Date

October 28, 2015

Last Update Submit

November 5, 2015

Conditions

Heart Failure

Keywords

Nutritional statusMNAGSA

Outcome Measures

Primary Outcomes (1)

  • Change on nutritional status measured with Global Subjective Assesment

    At inclusion , months 3 and 9

Secondary Outcomes (3)

  • Change on quality of life of patients measured with Minnesota Living With Heart Failure Questionnaire, after an educational intervention and nutritional supplement

    At inclusion , months 3 and 9

  • Change on meters walked in six minutes (functional capacity), after the intervention

    At inclusion , months 3 and 9

  • Number of readmission.

    at month 12

Study Arms (2)

educational intervention and supplements

EXPERIMENTAL

structured educational intervention and dietary supplements

Dietary Supplement: Hypercaloric beveragesOther: educational structured counseling

usual interventions

ACTIVE COMPARATOR

Usual treatment without nutritional supplements or structured assessment

Other: standard treatment

Interventions

Hypercaloric beveragesDIETARY_SUPPLEMENT

Nutritional supplement: Hypercaloric beverages

educational intervention and supplements
standard treatmentOTHER

No other than standard treatment

usual interventions
educational structured counselingOTHER

Nutritional counseling leaded to patient and caregivers

educational intervention and supplements

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Nefrología Hospital General universitario Gregorio Maranon

Madrid, Madrid, 28007, Spain

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Luis Guerra, Nurse

    Hospital General Universitario Gregorio Maranon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

October 28, 2015

First Posted

November 9, 2015

Study Start

September 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 9, 2015

Record last verified: 2015-11

Locations

ES(1)