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Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure

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ClinicalTrials.gov Identifier: NCT02120014
Recruitment Status : Completed
First Posted : April 22, 2014
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Wayne L. Miller, M.D., Ph.D., Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Procedure: blood volume measurement Procedure: venous plethysmography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : April 21, 2014
Actual Primary Completion Date : July 6, 2018
Actual Study Completion Date : July 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Heart Failure Reduced EF

Patient prior to clinically ordered right heart catheterization identified patients will have a blood volume measurement completed in the nuclear medicine laboratory. Patients will receive an intravenous administration of low dose iodinated I-131 labeled albumin. Blood specimens (6 cc each) will be drawn at 6 minute intervals times 6. The analysis will be completed following the testing.

Venous plethysmography will be completed on eligible patients prior to the clinically indicated right heart catheterization. Calf and forearm venous compliance will be measured.

Measurements form the right heart catheterization will be recorded for analysis.

Procedure: blood 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.

Other Name: Blood Volume - Red Cell Mass

Procedure: venous 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

Experimental: Heart Failure Preserved EF

Patient prior to clinically ordered right heart catheterization identified patients will have a blood volume measurement completed in the nuclear medicine laboratory. Patients will receive an intravenous administration of low dose iodinated I-131 labeled albumin. Blood specimens (6 cc each) will be drawn at 6 minute intervals times 6. The analysis will be completed following the testing.

Venous plethysmography will be completed on eligible patients prior to the clinically indicated right heart catheterization. Calf and forearm venous compliance will be measured.

Measurements form the right heart catheterization will be recorded for analysis.

Procedure: blood 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.

Other Name: Blood Volume - Red Cell Mass

Procedure: venous 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




Primary Outcome Measures :
  1. Total Blood Volume Measurement [ Time Frame: 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 Outcome Measures :
  1. venous plethysmography [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120014


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Wayne L Miller, MD, PhD Mayo Clinic
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Responsible Party: Wayne L. Miller, M.D., Ph.D., Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02120014    
Other Study ID Numbers: 13-003912
First Posted: April 22, 2014    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Keywords provided by Wayne L. Miller, M.D., Ph.D., Mayo Clinic:
Heart Failure
Heart Failure Reduced Ejection Fraction
Heart Failure Preserved Ejection Fraction
Venous Plethysmography
Blood Volume Study
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases