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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

Tracking Information
First Submitted Date  ICMJE April 17, 2014
First Posted Date  ICMJE April 22, 2014
Last Update Posted Date October 24, 2018
Actual Study Start Date  ICMJE April 21, 2014
Actual Primary Completion Date July 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Congestive Heart Failure
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Procedure: blood volume measurement
    • Procedure: venous plethysmography
  • 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.

    Interventions:
    • Procedure: blood volume measurement
    • Procedure: venous plethysmography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 21, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 6, 2018
Actual Primary Completion Date July 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02120014
Other Study ID Numbers  ICMJE 13-003912
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wayne L. Miller, M.D., Ph.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wayne L Miller, MD, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP