Study of Electrical Bioimpedance in Heart Failure.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heart Failure, Dyspnea

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| heart failure<br>Heart failure attending a HF clinic with or without clinical decompensation | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Electric bioimpedance, Body composition, Diagnosis, monitoring, Prognosis, Total body water