Congestive Heart Failure
Conditions
Keywords
Heart Failure, Heart Failure Reduced Ejection Fraction, Heart Failure Preserved Ejection Fraction, Venous Plethysmography, Blood Volume Study
Brief 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.
Interventions
PROCEDUREblood volume measurement
Patients 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 plethysmography
venous 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
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Blood Volume Measurement | Baseline prior to a clinically indicated right heart catheterization. | Blood volume will be measured at baseline for eligible patients prior to a clinical right heart catheterization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| venous plethysmography | Baseline prior to a clinically indicated right heart catheterization. | venous plethysmography will be measured at baseline for eligible patients prior to a clinical right heart catheterization. |
Countries
United States
Outcome results
None listed