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
  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.

Resource links provided by NLM:


Further study details as provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843245

Contacts
Contact: Nuria Ribas Pizá 0034932919000 ext 1461 NRIBAS@santpau.cat
Contact: Laura Astier Villaescusa 0034932919000 ext 1461 lastier@santpau.cat

Locations
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   
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Universitat Politècnica de Catalunya
Investigators
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:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014