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Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation

Sponsor
Medical University of Graz (Other)
Overall Status
Recruiting
CT.gov ID
NCT04842591
Collaborator
Janssen-Cilag G.m.b.H (Industry)
60
Enrollment
1
Location
36.2
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: exercise echocardiography

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Characteristics of Pulmonary Vascular Changes in Patients With Kidney Transplantation
Actual Study Start Date :
Dec 23, 2020
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
kidney transplant candidates

Patients listed for first kidney transplantation

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

Outcome Measures

Primary Outcome Measures

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

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

  3. Change in mean pulmonary arterial pressure at rest before versus one year after kidney transplantation [Baseline and 1 year after kidney transplantation]

  4. Change in mean pulmonary arterial pressure during exercise before versus one year after kidney transplantation [Baseline and 1 year after kidney transplantation]

  5. Change in pulmonary vascular resistance at rest before versus one year after kidney transplantation [Baseline and 1 year after kidney transplantation]

  6. Change in pulmonary vascular resistance during exercise before versus one year after kidney transplantation [Baseline and 1 year after kidney transplantation]

  7. Change in pulmonary arterial wedge pressure at rest before versus one year after kidney transplantation [Baseline and 1 year after kidney transplantation]

  8. Change in pulmonary arterial wedge pressure during exercise before versus one year after kidney transplantation [Baseline and 1 year after kidney transplantation]

  9. Change in cardiac output at rest before versus one year after kidney transplantation [Baseline and 1 year after kidney transplantation]

  10. Change in cardiac output during exercise before versus one year after kidney transplantation [Baseline and 1 year after kidney transplantation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Graz, Department of Internal Medicine, Division of Pulmonology Graz Austria 8036

Sponsors and Collaborators

  • Medical University of Graz
  • Janssen-Cilag G.m.b.H

Investigators

  • Principal Investigator: Gabor Kovacs, MD, PhD, Medical University of Graz, Department of Internal Medicine, Division of Pulmonology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT04842591
Other Study ID Numbers:
  • 33-022 ex 20/21
First Posted:
Apr 13, 2021
Last Update Posted:
Apr 13, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Medical University of Graz
pulmonary hypertension
kidney transplantation
vascular remodeling
echocardiography
pulmo-renal axis
Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension

Study Results

No Results Posted as of Apr 13, 2021