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

NCT07563608 | Recruiting

• 1 other identifier: P_4110
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

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

  Baseline (enrollment)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (18-75 years old) with end-stage renal disease who have been receiving stable extracorporeal hemodialysis for at least six months at participating multicenter dialysis units.

You may qualify if:

• 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

You may not qualify if:

• WHO functional class IV
• Presence of valvular or congenital heart disease
• Acute infections within the month preceding the cardiological evaluation

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo di Pavia

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 4, 2026
• Study Start: November 10, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

IT (1)