Heart FailureVAINICANCT02599935
Nutritional Improvement in Chronic Heart Failure Patients
A study testing Hypercaloric beverages, standard treatment and educational structured counseling in people with Heart Failure, run by Luis Guerra at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Hypercaloric beverages, standard treatment and educational structured counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Nefrología Hospital General universitario Gregorio Maranon
Madrid, Madrid, 28007
About this study
Official title: Impact on Nutrition and Quality of Life of Patients With Heart Failure After a Nurse Intervention on Nutrition Improvement
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
Read the 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
- Being tested
- Hypercaloric beverages, standard treatment, educational structured counseling
- Keywords
- Nutritional status, MNA, GSA
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypercaloric beveragesDietary supplement
Nutritional supplement: Hypercaloric beverages
standard treatmentOther
No other than standard treatment
educational structured counselingOther
Nutritional counseling leaded to patient and caregivers
| Study group | Role | What they receive |
|---|---|---|
| educational intervention and supplements | Experimental | structured educational intervention and dietary supplements Receives: Dietary Supplement: Hypercaloric beverages; Other: educational structured counseling |
| usual interventions | Active comparator | Usual treatment without nutritional supplements or structured assessment Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on nutritional status measured with Global Subjective Assesment
Measured: 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
Measured: At inclusion , months 3 and 9
Change on meters walked in six minutes (functional capacity), after the intervention
Measured: At inclusion , months 3 and 9
Number of readmission.
Measured: at month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startSep 2011
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis Guerra
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor-investigator, Luis Guerra, Hospital General Universitario Gregorio Marañon
- Investigators
- Luis Guerra, Nurse, Principal investigator, Hospital General Universitario Gregorio Maranon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599935
- Sponsor's protocol ID
- PI11/02428
- Acronym
- VAINICA
- Status last verified
- Nov 2015
- First submitted
- 28 Oct 2015
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Nutrition and Quality of Life of Patients With Heart Failure After a Nurse Intervention on Nutrition Improvement
- ClinicalTrials.gov ID
- NCT02599935
- Acronym / sponsor ID
- VAINICA / PI11/02428
- Conditions
- Heart Failure
- Keywords
- Nutritional status, MNA, GSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Luis GuerraUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Sep 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| educational intervention and supplements | Experimental | Dietary Supplement: Hypercaloric beverages, Other: educational structured counselingstructured educational intervention and dietary supplements |
| usual interventions | Active comparator | Other: standard treatmentUsual treatment without nutritional supplements or structured assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypercaloric beveragesNutritional supplement: Hypercaloric beverages | Dietary supplement | educational intervention and supplements |
| standard treatmentNo other than standard treatment | Other | usual interventions |
| educational structured counselingNutritional counseling leaded to patient and caregivers | Other | educational intervention and supplements |
Primary outcome
Change on nutritional status measured with Global Subjective Assesment
Time frame: At inclusion , months 3 and 9
3 secondary outcomes
Change on quality of life of patients measured with Minnesota Living With Heart Failure Questionnaire, after an educational intervention and nutritional supplement
Time frame: At inclusion , months 3 and 9
Change on meters walked in six minutes (functional capacity), after the intervention
Time frame: At inclusion , months 3 and 9
Number of readmission.
Time frame: at month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Guerra, Nurse principal investigator
Hospital General Universitario Gregorio Maranon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypercaloric beverages, standard treatment and educational structured counseling in people with Heart Failure, run by Luis Guerra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change on nutritional status measured with Global Subjective Assesment (time frame: At inclusion , months 3 and 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2015.