Study of Electrical Bioimpedance in Heart Failure. (BELIC)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Heart Failure Dyspnea |
Other: No intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Study of Electrical Bioimpedance in Heart Failure Patients Followed at the Heart Failure Unit of the Santa Creu i Sant Pau Hospital. |
- To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- To study the relation between electrical bioimpedance changes with patients' clinical situation (compensated versus decompensated HF) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- To assess potential correlations between impedance, clinical status, heart failure functional class, and NT-proBNP. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
Blood serum obtained from routine blood test
| Estimated Enrollment: | 400 |
| Study Start Date: | April 2009 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
heart failure
Heart failure attending a HF clinic with or without clinical decompensation
|
Other: No intervention
No intervention
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Consecutive patients attended at the Heart Failure Unit of the Hospital de la Santa Creu i Sant Pau
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
Contacts and Locations| Contact: Nuria Ribas Pizá | 0034932919000 ext 1461 | NRIBAS@santpau.cat |
| Contact: Laura Astier Villaescusa | 0034932919000 ext 1461 | lastier@santpau.cat |
| Spain | |
| 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 |
More Information
Publications:
| Responsible Party: | Dr. Antoni Bayés-Genís, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| ClinicalTrials.gov Identifier: | NCT00843245 History of Changes |
| Other Study ID Numbers: | ICREC 001-2009 |
| Study First Received: | February 12, 2009 |
| Last Updated: | June 21, 2011 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
|
Heart Failure Electric bioimpedance Body composition Diagnosis |
monitoring Prognosis Total body water |
Additional relevant MeSH terms:
|
Dyspnea Heart Failure Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013