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Prevalence of Kidney Disease, Hemodynamic Predictors and Long-Term Renal Outcome in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03045614
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Faeq Husain, University of Giessen

Brief Summary:
Evaluation of the prevalence of kidney disease, hemodynamic predictors and long-term renal outcome in patients with invasively diagnosed pulmonary hypertension.

Condition or disease Intervention/treatment
Pulmonary Hypertension Other: No intervention

Detailed Description:
This study aims to determine the prevalence of kidney disease, hemodynamic predictors and long-term renal outcome in patients with invasively diagnosed pulmonary hypertension and referred to the reference center for pulmonary hypertension, University Hospital Giessen and Marburg, Campus Giessen between 1999 and 2013.

Study Type : Observational
Actual Enrollment : 826 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence of Kidney Disease, Hemodynamic Predictors and Long-Term Renal Outcome in Pulmonary Hypertension - A Single Centre, Retrospective Analysis
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 27, 2018
Actual Study Completion Date : August 28, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. Changes in estimated glomerular filtration rate (GFR) in each class of pulmonary hypertension during follow-up period [ Time Frame: 3 years follow-up ]
    Estimated GFR (Chronic Kidney Disease Epidemiology Collaboration) will be used over follow-up period to determine changes in renal function

  2. Impact of renal function on deterioration of pulmonary hypertension during follow-up period [ Time Frame: 3 years follow-up ]
    Changes in estimated GFR (Chronic Kidney Disease Epidemiology Collaboration) over follow-up period will be correlated with clinical worsening of pulmonary hypertension (as determined by echocardiography, 6-minute-walk, New York Heart Association classification, b-type natriuretic peptide)


Secondary Outcome Measures :
  1. Impact of pulmonary hypertension-related morbidity on renal function decline [ Time Frame: 3 years follow-up ]
    Severity of pulmonary hypertension (progress pulmonary hypertension, unscheduled hospitalization due to worsening of pulmonary hypertension, mortality) will be correlated with changes in renal function (as determined by estimated GFR [Chronic Kidney Disease Epidemiology Collaboration])

  2. Prevalence of proteinuria in pulmonary hypertension [ Time Frame: At baseline ]
    24 hours urine collection at baseline will be assessed to predict progress of pulmonary hypertension

  3. Impact of pulmonary hypertension-specific therapy on renal function decline [ Time Frame: 3 years follow-up ]
    Estimated GFR (Chronic Kidney Disease Epidemiology Collaboration) over follow-up period will be assessed to show association of pulmonary hypertension-specific therapy on renal function


Biospecimen Retention:   Samples With DNA
Collection of only residual material (blood, urine) for Deutsche Zentrum für Lungenforschung Biobank.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with invasively diagnosed pulmonary hypertension between 1999 and 2013 at reference center for pulmonary hypertension, University Hospital Giessen
Criteria

Inclusion Criteria:

  • Older than 18 years
  • Subjects with invasively diagnose pulmonary hypertension between 1999 and 2013 at reference center for pulmonary hypertension, University Hospital Giessen
  • Subjects with exclusion of manifest pulmonary hypertension in domo under pulmonary hypertension-specific therapy diagnosed at external center

Exclusion Criteria:

  • Subjects with estimated GFR < 15ml/min/1.73m2 or requiring dialysis (acute or chronic maintenance)
  • Latent pulmonary hypertension
  • Subjects with pulmonary hypertension with unclear/multifactorial mechanisms (WHO group 5)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045614


Locations
Germany
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Investigators
Study Director: Werner Seeger, MD University Clinic Giessen and Marburg, Campus Giessen

Publications of Results:
Responsible Party: Faeq Husain, Senior Physician Nephrology, University of Giessen
ClinicalTrials.gov Identifier: NCT03045614     History of Changes
Other Study ID Numbers: AZ 238/16
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases