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

NCT00603213 | Completed

• 1 other identifier: HR16840
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Impedance; Optivol Thoracid Fluid Status monitoring system

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Interventions

Blood Volume Analysis, Echocardiogram PROCEDURE

Blood Volume Analysis: The use of radioactive tracer to determine plasma volume and red cell mass. Echocardiogram is an ultrasound of the heart.

Also known as: BVA-100, Daxor Corp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Medtronic: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Adrian VanBakel, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 29, 2008
• Study Start: January 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: February 1, 2011
• Last Updated: May 22, 2013

Record last verified: 2013-05

Locations

US (1)