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Study of Electrical Bioimpedance in Heart Failure. (BELIC)

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ClinicalTrials.gov Identifier: NCT00843245
Recruitment Status : Unknown
Verified June 2011 by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
Recruitment status was:  Recruiting
First Posted : February 13, 2009
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Universitat Politècnica de Catalunya
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date February 12, 2009
First Posted Date February 13, 2009
Last Update Posted Date June 22, 2011
Study Start Date April 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: February 12, 2009)
To identify if electrical bioimpedance analysis is useful for diagnosis, monitoring and prognosis in patients with heart failure. [ Time Frame: 18 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 12, 2009)
  • 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 ]
  • To study the relation between electrical bioimpedance changes with patients' clinical situation (compensated versus decompensated HF) [ Time Frame: 18 months ]
  • To assess potential correlations between impedance, clinical status, heart failure functional class, and NT-proBNP. [ Time Frame: 18 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of Electrical Bioimpedance in Heart Failure.
Official Title Study of Electrical Bioimpedance in Heart Failure Patients Followed at the Heart Failure Unit of the Santa Creu i Sant Pau Hospital.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood serum obtained from routine blood test
Sampling Method Probability Sample
Study Population Consecutive patients attended at the Heart Failure Unit of the Hospital de la Santa Creu i Sant Pau
Condition
  • Heart Failure
  • Dyspnea
Intervention Other: No intervention
No intervention
Study Groups/Cohorts heart failure
Heart failure attending a HF clinic with or without clinical decompensation
Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 12, 2009)
400
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00843245
Other Study ID Numbers ICREC 001-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Antoni Bayés-Genís, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date June 2011