CompletedNot Applicable

Blood Volume and Hemodynamic Analysis in Patients With Chronic Heart Failure

United States60 participantsStarted 2014-04-21

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total Blood Volume Measurement

Timeframe: Baseline prior to a clinically indicated right heart catheterization.

Trial details

NCT IDNCT02120014

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-07-06

View on ClinicalTrials.gov More Congestive Heart Failure trials