Study of Electrical Bioimpedance in Heart Failure. (BELIC)

June 21, 2011 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
heart failure
Heart failure attending a HF clinic with or without clinical decompensation
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
18 months
To study the relation between electrical bioimpedance changes with patients' clinical situation (compensated versus decompensated HF)
Time Frame: 18 months
18 months
To assess potential correlations between impedance, clinical status, heart failure functional class, and NT-proBNP.
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2011

Last Update Submitted That Met QC Criteria

June 21, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICREC 001-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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