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Heart Failure Preserved EF for Congestive Heart Failure

N/A
Waitlist Available
Led By Wayne L Miller, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline prior to a clinically indicated right heart catheterization.
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Congestive Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline prior to a clinically indicated right heart catheterization.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline prior to a clinically indicated right heart catheterization. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total Blood Volume Measurement
Secondary study objectives
venous plethysmography

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Heart Failure Reduced EFExperimental Treatment2 Interventions
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.
Group II: Heart Failure Preserved EFExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
venous plethysmography
2014
N/A
~60
blood volume measurement
2014
N/A
~60

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,350 Previous Clinical Trials
3,060,614 Total Patients Enrolled
Wayne L Miller, MD, PhDPrincipal InvestigatorMayo Clinic
~5 spots leftby Dec 2025
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