Study of Electrical Bioimpedance in Heart Failure. (BELIC)
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|ClinicalTrials.gov Identifier: NCT00843245|
Recruitment Status : Unknown
Verified June 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was: Recruiting
First Posted : February 13, 2009
Last Update Posted : June 22, 2011
|Condition or disease||Intervention/treatment|
|Heart Failure Dyspnea||Other: No intervention|
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 Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Study of Electrical Bioimpedance in Heart Failure Patients Followed at the Heart Failure Unit of the Santa Creu i Sant Pau Hospital.|
|Study Start Date :||April 2009|
Heart failure attending a HF clinic with or without clinical decompensation
Other: No intervention
- To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure. [ Time Frame: 18 months ]
- To analyze segmental and whole-body bioimpedance measures in a population of heart failure patients with multi frequency body composition analysis [ Time Frame: 18 months ]
- To study the relation between electrical bioimpedance changes with patients' clinical situation (compensated versus decompensated HF) [ Time Frame: 18 months ]
- To assess potential correlations between impedance, clinical status, heart failure functional class, and NT-proBNP. [ Time Frame: 18 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843245
|Contact: Nuria Ribas Pizá||0034932919000 ext 1461||NRIBAS@santpau.cat|
|Contact: Laura Astier Villaescusa||0034932919000 ext firstname.lastname@example.org|
|Hospital de la Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08025|
|Contact: Nuria Ribas Pizá, MD 34932909000 ext 1461 NRIBAS@santpau.cat|
|Contact: Laura Astier 34932909000 ext 1461 NRIBAS@santpau.cat|
|Principal Investigator:||Nuria Ribas Pizá, MD||Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau|