RecruitingNot Applicable

Prevalence, Pathogenesis, and Prognosis of Pulmonary Hypertension in Dialysis Patients

Italy70 participantsStarted 2018-11-10

Plain-language summary

This prospective multicenter longitudinal study aims to investigate the prevalence, pathogenesis, and prognosis of pulmonary hypertension in patients with end-stage renal disease undergoing chronic hemodialysis. The research seeks to identify specific clinical factors and biomarkers like angiopoietin-2 that contribute to the development of this condition, while evaluating the prognostic value of right ventricular function measured via TAPSE. Participants undergo a standardized screening echocardiogram the day after their intermediate dialysis session to determine the probability of pulmonary hypertension. Those identified as high-risk receive further diagnostic confirmation through right heart catheterization, respiratory function tests, and lung scans to clarify the underlying etiology. The protocol also evaluates the hemodynamic impact of high-flow arteriovenous fistulas and volume overload on pulmonary pressures. Clinical follow-up is conducted at baseline and subsequently at 6, 12, and 24 months to monitor patient outcomes and standardize therapeutic management according to established European guidelines.

Who can participate

Age range

18 Years – 75 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: * Patients aged between 18 and 75 years * Patients on stable extracorporeal hemodialysis for at least 6 months * Dialysis frequency of two or three times per week * Ability to provide written informed consent Exclusion Criteria: * WHO functional class IV * Presence of valvular or congenital heart disease * Acute infections within the month preceding the cardiological evaluation

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

Prevalence of pulmonary hypertension and its subtypes in patients undergoing chronic hemodialysis

Timeframe: Baseline (enrollment)

Trial details

NCT IDNCT07563608

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Pulmonary Hypertension trials