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Status unknownNCT00843245BELICUpdated Jun 22, 2011

Study of Electrical Bioimpedance in Heart Failure.

An observational study in Heart Failure and Dyspnea, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-06-22.

Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational

The sponsor has not verified this record recently (last verified Jun 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Heart failure (HF) is a clinical syndrome presenting currently a high prevalence, morbidity and mortality. The lack of sensitivity of symptoms and signs used to make the diagnosis of the exacerbation of HF, and the knowledge in recent years about the relevance to detect congestion before consulting a specialist or go to the emergency department, support the need of more aggressive management of these patients.

Bioimpedance monitoring devices for bioimpedance can provide useful data for the detection of congestion onset and help the decision-making in treatment.

Because patients with heart failure suffer alterations in body composition, mainly due to the amount of extracellular water, the bioimpedance can objectify these variations. In heart failure, bioimpedance has been tested in two studies with small samples of patients estimating total body water. In other studies , the monitoring of intrathoracic impedance has been performed by measurement systems implanted in cardiac defibrillators or in cardiac resynchronization devices. They have proven to be useful for early detection of decompensation in these patients and to detect changes in impedance before the patient begins the clinical manifestations. Furthermore, it has been correlated the detection of decompensation by these devices with significant increases in NT- proBNP (diagnostic and prognostic marker for HF).

The purpose of our study is to observe these changes in impedance from the patient's skin surface and non-invasively.

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Conditions studied

  • Heart Failure
  • Dyspnea

Keywords

  • Heart Failure
  • Electric bioimpedance
  • Body composition
  • Diagnosis
  • monitoring
  • Prognosis
  • Total body water
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In context

Heart Failure

5,803 studies on the registry are indexed under Heart Failure; 1,222 are open to participants now.

This study's planned enrollment of 400 is above the median of 200 across 1,719 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 342 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive patients attended at the Heart Failure Unit of the Hospital de la Santa Creu i Sant Pau

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Outpatients > 18 years of age, male or female

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Biospecimen retention
Samples without dna

Groups and cohorts

  • heart failure

    Heart failure attending a HF clinic with or without clinical decompensation

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

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

    Time frame: 18 months

Secondary outcomes

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

    Time frame: 18 months

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

    Time frame: 18 months

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

    Time frame: 18 months

07

Study locations

1 of 1 sites recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Barcelona 08025, Spain
    Recruiting
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References and documents

Publications

  • 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. PubMed 7967368 ↗
  • 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. PubMed 16914106 ↗
  • 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. PubMed 11347985 ↗
  • 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. PubMed 9502185 ↗
  • 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. PubMed 16061743 ↗
  • 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. PubMed 17462948 ↗
  • 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. PubMed 19084379 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00843245
Collaborators
Universitat Politècnica de Catalunya
First posted
Feb 13, 2009
Start date
Apr 2009
Last update
Jun 22, 2011

Study contacts

Nuria Ribas Pizá
Contact
NRIBAS@santpau.cat
0034932919000 ext. 1461
Laura Astier Villaescusa
Contact
lastier@santpau.cat
0034932919000 ext. 1461
Nuria Ribas Pizá, MD
principal investigator · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.

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