Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/26/2018
Start Date:April 21, 2014
End Date:July 6, 2018

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A Prospective Study to Determine the Association of Quantitated Blood and Plasma (Intravascular) Volume to Right Heart Hemodynamics, Venous Capacitance, and Regulatory Neurohormones in Patients With Chronic Heart Failure of Reduced and Preserved Ejection Fraction

The primary hypothesis is that patients with HFREF (heart failure with reduced ejection
fraction) will demonstrate a markedly expanded intravascular volume which will correlate with
elevated right heart hemodynamics and increased venous capacitance parameters, whereas
patients with HFPEF(heart failure with preserved ejection fraction) will demonstrate
euvolemia to mild volume expansion and a lack of correlation with hemodynamic and venous
compliance parameters.

The purpose of this study is to learn more about how the heart, blood vessels and blood
volume interact in patients with heart failure and how measuring blood volume and vein
capacity may help us develop better ways of treating and managing heart failure patients.
This study will use two tests to measure blood volume and test the capacity of your veins and
arteries in your limbs.

The blood volume test (also called a plasma volume test or a red cell mass test) is a
standard clinical nuclear lab procedure used to measure the volume (amount) of blood in the
body. The test also measures the volume of plasma and of red cells in the blood.

The other test is called a venous plethysmography, which is a non-invasive test to measure
how well your veins and arteries in your forearm and calf work. Venous plethysmography
measures the changes in the dimensions of your limbs by the use of strain gauges placed on
the skin.

Inclusion Criteria:

- age >18 years

- patients identified with heart failure and diagnosed clinically to require right heart
hemodynamic evaluation, New York Heart Association functional Class II-IV status/Stage
C-D heart failure

- ischemic or nonischemic etiology heart failure

- left ventricular ejection fraction measured within 6 months of study enrollment

Exclusion Criteria:

- known significant intrinsic chronic kidney disease (baseline Glomerular Filtration
Rate <15 ml/min/1.73m²) or patients receiving hemodialysis

- known renal artery stenotic disease

- females who are pregnant

- allergy to iodine contrast, intravenous pyelogram dye, shellfish or eggs.
We found this trial at
1
site
200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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