Clinical Trials Directory

Trials / Completed

CompletedNCT02120014

Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREblood volume measurementPatients will drink a solution 30 minutes prior to the test. They will need to lie still on a flat surface for 15 minutes. During the blood volume analysis portion of the test, a small amount of a radioactive isotope or tracer is injected.Blood samples are taken at 6 time points during the test. The blood volume test is used to measure the amount of blood in the patients body. A hematocrit measurement is done on the blood samples taken. This blood test calculates the percentage of red blood cells in the bloodstream.
PROCEDUREvenous plethysmographyvenous plethysmography is a non-invasive test to measure how well your veins and arteries in your forearm and calf work. Cuffs similar to blood pressure cuffs are placed on the upper and lower arm and the thigh and calf. Measurements are taken

Timeline

Start date
2014-04-21
Primary completion
2018-07-06
Completion
2018-07-06
First posted
2014-04-22
Last updated
2018-10-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02120014. Inclusion in this directory is not an endorsement.