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Active, Not Recruiting

NCT Number: NCT04842591

Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

The aim of the study is to investigate pulmonary hemodynamics at rest and during exercise in patients before and after kidney transplantation.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Haemodialysis Hypertension Hypertension, Pulmonary Kidney Transplantation Lung Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Vascular Diseases Vascular Remodeling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz, Department of Internal Medicine, Division of Pulmonology

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: ≥ 18 years
  • patients listed for first kidney transplantation at the Clinical Division of Nephrology

Exclusion criteria

  • Age < 18 years
  • combined organ transplantations (heart-kidney, pancreas-kidney etc.)
  • patients with prior kidney transplantation
  • high calcium score on cardiac-CT (> 160 Agatston Score)

Treatment and study plan

exercise echocardiography

Diagnostic Test

All patients will undergo exercise echocardiography during a symptom-limited cardiopulmonary exercise test.

Primary outcomes

  1. Change in the systolic pulmonary arterial pressure/cardiac output (SPAP/CO) slope

    Time frame: Baseline and 1 year after kidney transplantation

    Change in the systolic pulmonary arterial pressure/cardiac output (SPAP/CO) slope (calculated as the difference of maximal and resting SPAP divided by the difference of maximal and resting CO) before versus one year after kidney transplantation assessed by exercise echocardiography

Secondary outcomes

  1. Change in systolic pulmonary arterial pressure at rest before versus one year after kidney transplantation assessed by (exercise) echocardiography

    Time frame: Baseline and 1 year after kidney transplantation

  2. Change in systolic pulmonary arterial pressure at 25 Watts before versus one year after kidney transplantation assessed by (exercise) echocardiography

    Time frame: Baseline and 1 year after kidney transplantation

  3. Change in mean pulmonary arterial pressure at rest before versus one year after kidney transplantation

    Time frame: Baseline and 1 year after kidney transplantation

  4. Change in mean pulmonary arterial pressure during exercise before versus one year after kidney transplantation

    Time frame: Baseline and 1 year after kidney transplantation

  5. Change in pulmonary vascular resistance at rest before versus one year after kidney transplantation

    Time frame: Baseline and 1 year after kidney transplantation

  6. Change in pulmonary vascular resistance during exercise before versus one year after kidney transplantation

    Time frame: Baseline and 1 year after kidney transplantation

  7. Change in pulmonary arterial wedge pressure at rest before versus one year after kidney transplantation

    Time frame: Baseline and 1 year after kidney transplantation

  8. Change in pulmonary arterial wedge pressure during exercise before versus one year after kidney transplantation

    Time frame: Baseline and 1 year after kidney transplantation

  9. Change in cardiac output at rest before versus one year after kidney transplantation

    Time frame: Baseline and 1 year after kidney transplantation

  10. Change in cardiac output during exercise before versus one year after kidney transplantation

    Time frame: Baseline and 1 year after kidney transplantation

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • Janssen-Cilag G.m.b.H

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2021
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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