CompletedNot Applicable

Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction

Russia20 participantsStarted 2018-06-18

Plain-language summary

This is a single-arm cohort study aimed to evaluate change of arteriovenous fistula volume blood flow / cardiac output ratio in patients with chronic heart failure (NYHA I-II classes) and with preserved ejection fraction as a result of a hemodialysis session after a "long" interdialysis interval.

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: * signed informed consent, * \> 18 years * maintenance ("chronic") hemodialysis, * native arteriovenous fistula, * arteriovenous fistula volume blood flow ≥1 l/min, * arteriovenous fistula volume blood flow / cardiac output ratio \< 0.3, * interdialysis weight gain \<5% of "dry" body weight, * sufficient hemodialysis dose (eKt/V \> 1.2), * chronic heart failure (NYHA I-II classes only), * preserved left ventricular ejection fraction (≥50%), * absence of arrhythmias (except first-degree atrioventricular block block), * absence of heart valve disease (except mitral regurgitation grade I-II), * absence of intradialysis hypo/hypertension * "long" interdialysis interval (3 days). Exclusion Criteria: * hypo/hypertension during or after hemodialysis, * arrhythmias (except first-degree atrioventricular block) after hemodialysis.

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

Change in cardio-fistular recirculation

Timeframe: One hour before and two hours after the hemodialysis session.

Trial details

NCT IDNCT06394986

SponsorMoscow Regional Research and Clinical Institute (MONIKI)

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2019-02-18

View on ClinicalTrials.gov More Chronic Kidney Disease 5D trials

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.