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Recruiting NCT07563608

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

Observational Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pulmonary Hypertension. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Prevalence of pulmonary hypertension and its subtypes in patients undergoing chronic hemodialysis [Time frame: Baseline (enrollment)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione IRCCS Policlinico San Matteo di Pavia — Pavia

Identifiers

NCT: NCT07563608 · P_4110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗