Heart FailurePLICANCT01396824
Nutritional Status and Prognosis in Heart Failure.
An observational study of Heart Failure, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether nutritional status or body composition influences the prognosis of heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 214 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2011to Sep 2014
- Phase
- Observational
- 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
Study population: Consecutive heart failure patients attending the HF clinic of a university hospital.
Who may be able to join
- Clinical diagnosis of heart failure according to the European Guidelines of Heart Failure.
- Depressed LVEF (< 45%) or ≥ 1 hospital admission due to HF decompensation
- Outpatients > 18 years of age, male or female, capable of giving an informed consent.
Who cannot join
- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
- Myopathy or other diseases that could cause significant sarcopenia beyond HF.
- Non-controlled hyperthyroidism
Trial locations and contacts
1 site in 1 country.
Spain1 site
Germans Trias Research Institute; Germans Trias University Hospital
Badalona, Barcelona, 08916
About this study
Official title: Nutrition Status and Body Composition in Ambulatory Patients With Heart Failure and Its Prognostic Significance (PLiegues en Insuficiencia Cardiaca-PLICA).
The purpose of this study is to determine whether nutritional status or body composition influences the prognosis of heart failure patients.
Read the detailed description
Despite obesity is a cardiovascular risk factor, numerous studies have identified a better prognosis in overweight and obese heart failure (HF) patients. This paradox has been named "the obesity paradox". However, this paradox has been criticized because the parameter used to classify obesity, the body mass index (BMI), has several limitations. Obesity is defined as an abnormal or excessive fat accumulation, and BMI does not always reflect real body fat.
What is more, patients with HF can have their body composition altered with hyperhydration or undernourishment. A pilot study proved that BMI does not indicate true nutritional status in HF. Thus, a further assessment of body composition of HF patients, analyzing the nutritional status rather BMI, could shed light on the obesity paradox. The aim of this study was to assess the nutritional status of a cohort of HF patients, its correspondence with BMI, and its significance in terms of survival.
- Conditions
- Heart Failure
- Being tested
- No intervention
- Keywords
- Malnutrition, Undernutrition, Nutrition Assessment, Nutritional Assessment, Nutritional Index, Prognostic Nutritional Index, Prognostic Nutritional Index (PNI), Nutritional Status, Prognosis, Heart Failure, Cardiovascular Diseases, Body Composition, Body Weights and Measures
- Medical subject headings
- Heart Failure, Malnutrition, Cardiovascular Diseases, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Heart failure patients attending a HF clinic with depressed LVEF (< 45%) or ≥ 1 hospital admission due to HF decompensation. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
Measured: 3 years
Secondary outcomes (2)
Cardiac mortality and non-cardiac mortality
Measured: 3 years
Heart failure hospitalizations
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoni Bayés Genís, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396824
- Sponsor's protocol ID
- ICREC-2011-01
- Acronym
- PLICA
- Status last verified
- Jun 2016
- First submitted
- 18 Jul 2011
- Last updated
- 2 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavie CJ, Milani RV, Artham SM, Patel DA, Ventura HO. The obesity paradox, weight loss, and coronary disease. Am J Med. 2009 Dec;122(12):1106-14. doi: 10.1016/j.amjmed.2009.06.006. Epub 2009 Aug 13.
PubMed 19682667Curtis JP, Selter JG, Wang Y, Rathore SS, Jovin IS, Jadbabaie F, Kosiborod M, Portnay EL, Sokol SI, Bader F, Krumholz HM. The obesity paradox: body mass index and outcomes in patients with heart failure. Arch Intern Med. 2005 Jan 10;165(1):55-61. doi: 10.1001/archinte.165.1.55.
PubMed 15642875Lavie CJ, Milani RV, Ventura HO, Romero-Corral A. Body composition and heart failure prevalence and prognosis: getting to the fat of the matter in the "obesity paradox". Mayo Clin Proc. 2010 Jul;85(7):605-8. doi: 10.4065/mcp.2010.0333. No abstract available.
PubMed 20592168Kalantar-Zadeh K, Block G, Horwich T, Fonarow GC. Reverse epidemiology of conventional cardiovascular risk factors in patients with chronic heart failure. J Am Coll Cardiol. 2004 Apr 21;43(8):1439-44. doi: 10.1016/j.jacc.2003.11.039.
PubMed 15093881Gassull MA, Cabre E, Vilar L, Alastrue A, Montserrat A. Protein-energy malnutrition: an integral approach and a simple new classification. Hum Nutr Clin Nutr. 1984 Nov;38(6):419-31.
PubMed 6440876Gastelurrutia P, Lupon J, Domingo M, Ribas N, Noguero M, Martinez C, Cortes M, Bayes-Genis A. Usefulness of body mass index to characterize nutritional status in patients with heart failure. Am J Cardiol. 2011 Oct 15;108(8):1166-70. doi: 10.1016/j.amjcard.2011.06.020. Epub 2011 Jul 26.
PubMed 21798500
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Status and Body Composition in Ambulatory Patients With Heart Failure and Its Prognostic Significance (PLiegues en Insuficiencia Cardiaca-PLICA).
- ClinicalTrials.gov ID
- NCT01396824
- Acronym / sponsor ID
- PLICA / ICREC-2011-01
- Conditions
- Heart Failure
- Keywords
- Malnutrition, Undernutrition, Nutrition Assessment, Nutritional Assessment, Nutritional Index, Prognostic Nutritional Index, Prognostic Nutritional Index (PNI), Nutritional Status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Jul 2011 (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.
The purpose of this study is to determine whether nutritional status or body composition influences the prognosis of heart failure patients.
Detailed description
Despite obesity is a cardiovascular risk factor, numerous studies have identified a better prognosis in overweight and obese heart failure (HF) patients. This paradox has been named "the obesity paradox". However, this paradox has been criticized because the parameter used to classify obesity, the body mass index (BMI), has several limitations. Obesity is defined as an abnormal or excessive fat accumulation, and BMI does not always reflect real body fat.
What is more, patients with HF can have their body composition altered with hyperhydration or undernourishment. A pilot study proved that BMI does not indicate true nutritional status in HF. Thus, a further assessment of body composition of HF patients, analyzing the nutritional status rather BMI, could shed light on the obesity paradox. The aim of this study was to assess the nutritional status of a cohort of HF patients, its correspondence with BMI, and its significance in terms of survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | Other: No interventionHeart failure patients attending a HF clinic with depressed LVEF (< 45%) or ≥ 1 hospital admission due to HF decompensation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive heart failure patients attending the HF clinic of a university hospital.
Key inclusion criteria (3 listed)
- Clinical diagnosis of heart failure according to the European Guidelines of Heart Failure.
- Depressed LVEF (< 45%) or ≥ 1 hospital admission due to HF decompensation
- Outpatients > 18 years of age, male or female, capable of giving an informed consent.
Key exclusion criteria (3 listed)
- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
- Myopathy or other diseases that could cause significant sarcopenia beyond HF.
- Non-controlled hyperthyroidism
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 |
|---|---|---|
| No interventionNo intervention | Other | Heart failure |
Primary outcome
All cause mortality
Time frame: 3 years
2 secondary outcomes
Cardiac mortality and non-cardiac mortality
Time frame: 3 years
Heart failure hospitalizations
Time frame: 3 years
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 2 Jun 2016.
- Background: PubMed 19682667Lavie CJ, Milani RV, Artham SM, Patel DA, Ventura HO. The obesity paradox, weight loss, and coronary disease. Am J Med. 2009 Dec;122(12):1106-14. doi: 10.1016/j.amjmed.2009.06.006. Epub 2009 Aug 13.
- Background: PubMed 15642875Curtis JP, Selter JG, Wang Y, Rathore SS, Jovin IS, Jadbabaie F, Kosiborod M, Portnay EL, Sokol SI, Bader F, Krumholz HM. The obesity paradox: body mass index and outcomes in patients with heart failure. Arch Intern Med. 2005 Jan 10;165(1):55-61. doi: 10.1001/archinte.165.1.55.
- Background: PubMed 20592168Lavie CJ, Milani RV, Ventura HO, Romero-Corral A. Body composition and heart failure prevalence and prognosis: getting to the fat of the matter in the "obesity paradox". Mayo Clin Proc. 2010 Jul;85(7):605-8. doi: 10.4065/mcp.2010.0333. No abstract available.
- Background: PubMed 15093881Kalantar-Zadeh K, Block G, Horwich T, Fonarow GC. Reverse epidemiology of conventional cardiovascular risk factors in patients with chronic heart failure. J Am Coll Cardiol. 2004 Apr 21;43(8):1439-44. doi: 10.1016/j.jacc.2003.11.039.
- Background: PubMed 6440876Gassull MA, Cabre E, Vilar L, Alastrue A, Montserrat A. Protein-energy malnutrition: an integral approach and a simple new classification. Hum Nutr Clin Nutr. 1984 Nov;38(6):419-31.
- Background: PubMed 21798500Gastelurrutia P, Lupon J, Domingo M, Ribas N, Noguero M, Martinez C, Cortes M, Bayes-Genis A. Usefulness of body mass index to characterize nutritional status in patients with heart failure. Am J Cardiol. 2011 Oct 15;108(8):1166-70. doi: 10.1016/j.amjcard.2011.06.020. Epub 2011 Jul 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Germans Trias i Pujol Hospital 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 3 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 2 Jun 2016. 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?
All cause mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01396824, which also lists 6 linked publications.
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 2 Jun 2016.