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Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
blood volume measurement
venous plethysmography
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Congestive Heart Failure focused on measuring Heart Failure, Heart Failure Reduced Ejection Fraction, Heart Failure Preserved Ejection Fraction, Venous Plethysmography, Blood Volume Study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Heart Failure Reduced EF

Heart Failure Preserved EF

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total Blood Volume Measurement
Blood volume will be measured at baseline for eligible patients prior to a clinical right heart catheterization.

Secondary Outcome Measures

venous plethysmography
venous plethysmography will be measured at baseline for eligible patients prior to a clinical right heart catheterization.

Full Information

First Posted
April 17, 2014
Last Updated
October 22, 2018
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02120014
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 21, 2014 (Actual)
Primary Completion Date
July 6, 2018 (Actual)
Study Completion Date
July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Heart Failure, Heart Failure Reduced Ejection Fraction, Heart Failure Preserved Ejection Fraction, Venous Plethysmography, Blood Volume Study

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Heart Failure Reduced EF
Arm Type
Experimental
Arm Description
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.
Arm Title
Heart Failure Preserved EF
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
blood volume measurement
Other Intervention Name(s)
Blood Volume - Red Cell Mass
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
venous plethysmography
Intervention Description
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 Measure Information:
Title
Total Blood Volume Measurement
Description
Blood volume will be measured at baseline for eligible patients prior to a clinical right heart catheterization.
Time Frame
Baseline prior to a clinically indicated right heart catheterization.
Secondary Outcome Measure Information:
Title
venous plethysmography
Description
venous plethysmography will be measured at baseline for eligible patients prior to a clinical right heart catheterization.
Time Frame
Baseline prior to a clinically indicated right heart catheterization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne L Miller, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure

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