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OpenTrials
Completed

NCT Number: NCT02120014

Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Diastolic Heart Failure, Systolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

blood volume measurement

Procedure

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 names: Blood Volume - Red Cell Mass

venous plethysmography

Procedure

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 22, 2014
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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