Study of Electrical Bioimpedance in Heart Failure.

NCT ID: NCT00843245

Last Updated: 2011-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-30

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.

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.

Conditions

Heart Failure; Dyspnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

heart failure

Heart failure attending a HF clinic with or without clinical decompensation

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Outpatients > 18 years of age, male or female

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitat Politècnica de Catalunya

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Nuria Ribas Pizá, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Nuria Ribas Pizá

Role: CONTACT

NRIBAS@santpau.cat

0034932919000 ext. 1461

Laura Astier Villaescusa

Role: CONTACT

lastier@santpau.cat

0034932919000 ext. 1461

Facility Contacts

Nuria Ribas Pizá, MD

Role: primary

NRIBAS@santpau.cat

34932909000 ext. 1461

Laura Astier

Role: backup

NRIBAS@santpau.cat

34932909000 ext. 1461

References

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.

Reference Type: BACKGROUND

PMID: 7967368 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16914106 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11347985 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9502185 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16061743 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17462948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19084379 (View on PubMed)

Other Identifiers

ICREC 001-2009

Identifier Type: -

Identifier Source: org_study_id