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Correlation of Intrathoracic Impedance Measures With Blood Plasma Volume in Congestive Heart Failure (Optivol)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Adrian Van Bakel, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00603213
First received: January 16, 2008
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

Congestive heart failure is a condition in which the heart is weakened and is unable to pump enough blood to the organs of the body to meet the demands of the body. At times there may be a buildup of fluid in the lungs, legs or other parts of the body. The accumulation of this fluid has been shown to affect the resistance to flow of the electrical impulses generated in the heart. The purpose of this study is to correlate measurements to the passive flow of electricity generated by the heart within the chest (as measured by the Optivol TFS System) with measurements of the volume of blood in the body.


Condition Intervention
Congestive Heart Failure
Procedure: Blood Volume Analysis, Echocardiogram

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Intrathoracic Impedance Measure With Blood Plasma Volume in Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 1. correlation between change in intrathoracic impedance and change in total blood volume 2.correlation between change in intrathoracic impedance and change in plasma volume [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

15 mls of blood will be drawn to assay for plasma analytes including but not limited to MMPs, TIMPs and collagen propeptides.


Enrollment: 25
Study Start Date: January 2007
Study Completion Date: February 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Blood Volume Analysis, Echocardiogram

    Blood Volume Analysis: The use of radioactive tracer to determine plasma volume and red cell mass.

    Echocardiogram is an ultrasound of the heart.

    Other Name: BVA-100, Daxor Corp
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients aged 18 years or older with NYHA Class II-IV CHF of at least six months duration who have been implated with a device capable of serial impedance measurement will be recruited.

Criteria

Inclusion Criteria:

  • Patients ≥ 18 years of age with NYHA II-IV CHF of at least six months duration who have been implanted with a device capable of serial intrathoracic impedance measurement (Optivol®) will be recruited.
  • Patients implanted with an Optivol ®device will be eligible for enrollment six months following implantation
  • Women of childbearing potential may be included if they have a negative urine pregnancy test at the time of enrollment and agree to use effective contraception throughout the study and for 1 month following their participation

Exclusion Criteria:

  • Thoracotomy within previous 3 months
  • Chronic pericardial or pleural effusion
  • Serum albumen < 2.8 g/dL
  • Women who are pregnant or lactating
  • Inability or unwillingness to maintain adequate contraception(women of childbearing potential) for the duration of the study and for 1 month following their participation
  • Inability to give informed consent
  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: NCT00603213

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Medtronic
Investigators
Principal Investigator: Adrian VanBakel, MD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Adrian Van Bakel, Professor of Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00603213     History of Changes
Other Study ID Numbers: HR16840
Study First Received: January 16, 2008
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Congestive Heart Failure
Impedance
Optivol Thoracid Fluid Status monitoring system

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 20, 2014