Correlation of Intrathoracic Impedance Measures With Blood Plasma Volume in Congestive Heart Failure
Completed
Conditions studied: Congestive Heart Failure
In brief
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.
Key facts
- Study ID
- NCT00603213
- Run by
- Medical University of South Carolina
- People needed
- 25
- Starts
- 2007-01-01
- Expected to finish
- 2011-02-01
- Last updated by the study team
- 2013-05-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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