Study of Electrical Bioimpedance in Heart Failure Patients Followed at the Heart Failure Unit of the Santa Creu i Sant Pau Hospital.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure.
- Last Updated
- 14 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure.
Time Frame: 18 months
Secondary Outcomes
- 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)