Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure

NCT02120014 | Completed DMC

• 1 other identifier: 13-003912
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

Heart Failure; Heart Failure Reduced Ejection Fraction; Heart Failure Preserved Ejection Fraction; Venous Plethysmography; Blood Volume Study

Outcome Measures

Primary Outcomes (1)

• Total Blood Volume Measurement

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

  Baseline prior to a clinically indicated right heart catheterization.

Secondary Outcomes (1)

• venous plethysmography

  Baseline prior to a clinically indicated right heart catheterization.

Study Arms (2)

Heart Failure Reduced EF

EXPERIMENTAL

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; Procedure: venous plethysmography

Heart Failure Preserved EF

EXPERIMENTAL

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; Procedure: venous plethysmography

Interventions

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.

Also known as: Blood Volume - Red Cell Mass

Heart Failure Preserved EF; Heart Failure Reduced EF

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

Heart Failure Preserved EF; Heart Failure Reduced EF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Heart Failure; Heart Failure, Systolic; Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wayne L Miller, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 22, 2014
• Study Start: April 21, 2014
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

US (1)