NCT00843245

Brief Summary

The purpose of this study is to determine how electrical impedance is modified in relation to extracellular space body fluid retention detected by an electrical bioimpedance method in patients with heart failure.

Trial Health

55
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Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

First QC Date

February 12, 2009

Last Update Submit

June 21, 2011

Conditions

Heart FailureDyspnea

Keywords

Heart FailureElectric bioimpedanceBody compositionDiagnosismonitoringPrognosisTotal body water

Outcome Measures

Primary Outcomes (1)

  • To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure.

    18 months

Secondary Outcomes (3)

  • To analyze segmental and whole-body bioimpedance measures in a population of heart failure patients with multi frequency body composition analysis

    18 months

  • To study the relation between electrical bioimpedance changes with patients' clinical situation (compensated versus decompensated HF)

    18 months

  • To assess potential correlations between impedance, clinical status, heart failure functional class, and NT-proBNP.

    18 months

Study Arms (1)

heart failure

Heart failure attending a HF clinic with or without clinical 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 patients attended at the Heart Failure Unit of the Hospital de la Santa Creu i Sant Pau

You may qualify if:

  • Outpatients \> 18 years of age, male or female

You may not qualify if:

  • Patients treated with renal substitutive treatment such as hemodialysis or peritoneal dialysis
  • Patients with automatic implantable devices or pacemakers.
  • Patients with metal prosthesis in right side of the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Related Publications (7)

  • Piccoli A, Rossi B, Pillon L, Bucciante G. A new method for monitoring body fluid variation by bioimpedance analysis: the RXc graph. Kidney Int. 1994 Aug;46(2):534-9. doi: 10.1038/ki.1994.305. No abstract available.

    PMID: 7967368BACKGROUND

  • Albert NM. Bioimpedance to prevent heart failure hospitalization. Curr Heart Fail Rep. 2006 Sep;3(3):136-42. doi: 10.1007/s11897-006-0013-y.

    PMID: 16914106BACKGROUND

  • Soderberg M, Hahn RG, Cederholm T. Bioelectric impedance analysis of acute body water changes in congestive heart failure. Scand J Clin Lab Invest. 2001 Apr;61(2):89-94. doi: 10.1080/00365510151097520.

    PMID: 11347985BACKGROUND

  • Steele IC, Young IS, Stevenson HP, Maguire S, Livingstone MB, Rollo M, Scrimgeour C, Rennie MJ, Nicholls DP. Body composition and energy expenditure of patients with chronic cardiac failure. Eur J Clin Invest. 1998 Jan;28(1):33-40. doi: 10.1046/j.1365-2362.1998.00245.x.

    PMID: 9502185BACKGROUND

  • Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, Christensen J, Stadler RW, Lau CP. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation. 2005 Aug 9;112(6):841-8. doi: 10.1161/CIRCULATIONAHA.104.492207. Epub 2005 Aug 1.

    PMID: 16061743BACKGROUND

  • Luthje L, Vollmann D, Drescher T, Schott P, Zenker D, Hasenfuss G, Unterberg C. Intrathoracic impedance monitoring to detect chronic heart failure deterioration: relationship to changes in NT-proBNP. Eur J Heart Fail. 2007 Jun-Jul;9(6-7):716-22. doi: 10.1016/j.ejheart.2007.03.005. Epub 2007 Apr 25.

    PMID: 17462948BACKGROUND

  • Nescolarde L, Rosell-Ferrer J, Gastelurrutia P, Bayes-Genis A, Calpe J, Hernandez R. Comment on "Is bioelectrical impedance vector analysis of value in the elderly with malnutrition and impaired functionality?". Nutrition. 2009 Mar;25(3):370-1; author reply 371-2. doi: 10.1016/j.nut.2008.10.009. Epub 2008 Dec 11. No abstract available.

    PMID: 19084379BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum obtained from routine blood test

MeSH Terms

Conditions

Heart FailureDyspneaDisease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Nuria Ribas Pizá, MD

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuria Ribas Pizá

CONTACT

0034932919000NRIBAS@santpau.cat

Laura Astier Villaescusa

CONTACT

0034932919000lastier@santpau.cat

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

April 1, 2009

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

ES(1)