Skip to content

Study of Electrical Bioimpedance in Heart Failure.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00843245
Acronym
BELIC
Enrollment
400
Registered
2009-02-13
Start date
2009-04-30
Completion date
Unknown
Last updated
2011-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea, Heart Failure

Keywords

Heart Failure, Electric bioimpedance, Body composition, Diagnosis, monitoring, Prognosis, Total body water

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Universitat Politècnica de Catalunya
CollaboratorOTHER
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
To assess potential correlations between impedance, clinical status, heart failure functional class, and NT-proBNP.18 months
To analyze segmental and whole-body bioimpedance measures in a population of heart failure patients with multi frequency body composition analysis18 months
To study the relation between electrical bioimpedance changes with patients' clinical situation (compensated versus decompensated HF)18 months

Countries

Spain

Contacts

Primary ContactNuria Ribas Pizá
NRIBAS@santpau.cat0034932919000
Backup ContactLaura Astier Villaescusa
lastier@santpau.cat0034932919000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026