Clinical trial NCT02120014: Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Keywords: Heart Failure
Heart Failure Reduced Ejection Fraction
Heart Failure Preserved Ejection Fraction
Venous Plethysmography
Blood Volume Study
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Blood Volume Measurement
timeFrame: Baseline prior to a clinically indicated right heart catheterization.
Secondary outcomes:
measure: venous plethysmography
timeFrame: Baseline prior to a clinically indicated right heart catheterization.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Wayne L Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: