NCT01396824

Brief Summary

The purpose of this study is to determine whether nutritional status or body composition influences the prognosis of heart failure patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

June 2, 2016

Status Verified

June 1, 2016

Enrollment Period

2.1 years

First QC Date

July 18, 2011

Last Update Submit

June 1, 2016

Conditions

Heart Failure

Keywords

MalnutritionUndernutritionNutrition AssessmentNutritional AssessmentNutritional IndexPrognostic Nutritional IndexPrognostic Nutritional Index (PNI)Nutritional StatusPrognosisHeart FailureCardiovascular DiseasesBody CompositionBody Weights and Measures

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    3 years

Secondary Outcomes (2)

  • Cardiac mortality and non-cardiac mortality

    3 years

  • Heart failure hospitalizations

    3 years

Study Arms (1)

Heart failure

Heart failure patients attending a HF clinic with depressed LVEF (\< 45%) or ≥ 1 hospital admission due to HF decompensation.

Other: No intervention

Interventions

No interventionOTHER

No intervention

Heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive heart failure patients attending the HF clinic of a university hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germans Trias Research Institute; Germans Trias University Hospital

Badalona, Barcelona, 08916, Spain

Location

Related Publications (6)

  • 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.

    PMID: 19682667BACKGROUND

  • Curtis 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.

    PMID: 15642875BACKGROUND

  • Lavie 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.

    PMID: 20592168BACKGROUND

  • Kalantar-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.

    PMID: 15093881BACKGROUND

  • Gassull 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.

    PMID: 6440876BACKGROUND

  • Gastelurrutia 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.

    PMID: 21798500BACKGROUND

MeSH Terms

Conditions

Heart FailureMalnutritionCardiovascular DiseasesBody Weight

Condition Hierarchy (Ancestors)

Heart DiseasesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Cardiology Service

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 19, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2013

Study Completion

September 1, 2014

Last Updated

June 2, 2016

Record last verified: 2016-06

Locations

ES(1)