Study of Electrical Bioimpedance in Heart Failure.

Heart Failure Clinical Trial

— BELIC  

Official title:

Study of Electrical Bioimpedance in Heart Failure Patients Followed at the Heart Failure Unit of the Santa Creu i Sant Pau Hospital.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00843245
• Other study ID #: ICREC 001-2009
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2009
• Last updated: June 21, 2011
• Start date: April 2009

Study information

• Verified date: June 2011
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Nuria Ribas Pizá
• Phone: 0034932919000
• Email: NRIBAS[@]santpau.cat
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Universitat Politècnica de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Albert NM. Bioimpedance to prevent heart failure hospitalization. Curr Heart Fail Rep. 2006 Sep;3(3):136-42. Review. — View Citation

Lüthje 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. Epub 2007 Apr 25. — View Citation

Nescolarde L, Rosell-Ferrer J, Gastelurrutia P, Bayés-Genis A, Calpe J, Hernández 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. — View Citation

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. — View Citation

Söderberg 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. — View Citation

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. — View Citation

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. Epub 2005 Aug 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure.		18 months	Yes
Secondary	To analyze segmental and whole-body bioimpedance measures in a population of heart failure patients with multi frequency body composition analysis		18 months	Yes
Secondary	To study the relation between electrical bioimpedance changes with patients' clinical situation (compensated versus decompensated HF)		18 months	Yes
Secondary	To assess potential correlations between impedance, clinical status, heart failure functional class, and NT-proBNP.		18 months	Yes