Study of Electrical Bioimpedance in Heart Failure. (BELIC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Universitat Politècnica de Catalunya
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00843245
First received: February 12, 2009
Last updated: June 21, 2011
Last verified: June 2011

February 12, 2009
June 21, 2011
April 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00843245 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood serum obtained from routine blood test

Probability Sample

Consecutive patients attended at the Heart Failure Unit of the Hospital de la Santa Creu i Sant Pau

  • Heart Failure
  • Dyspnea
Other: No intervention
No intervention
heart failure
Heart failure attending a HF clinic with or without clinical decompensation
Intervention: Other: No intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Nuria Ribas Pizá 0034932919000 ext 1461 NRIBAS@santpau.cat
Contact: Laura Astier Villaescusa 0034932919000 ext 1461 lastier@santpau.cat
Spain
 
NCT00843245
ICREC 001-2009
No
Dr. Antoni Bayés-Genís, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Universitat Politècnica de Catalunya
Principal Investigator: Nuria Ribas Pizá, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP