Study of Electrical Bioimpedance in Heart Failure.

• Conditions: Heart Failure; Dyspnea
• Interventions: Other: No intervention

• Registration Number: NCT00843245
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Timeline

• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Study Start: 2009-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
heart failure	No intervention	Heart failure attending a HF clinic with or without clinical decompensation

Primary Outcome Measures

Name	Time	Method
To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure.	18 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain