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Kidney Disease and Pulmonary Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045614
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : November 19, 2019
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 of in-hospital patients with invasively diagnosed pulmonary hypertension at the Department of Pulmonology, University Hospital Giessen and Marburg, Giessen, Germany between 1999 and 2016.

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Study Type : Observational
Actual Enrollment : 824 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence and Predictors of Kidney Disease, and Long-Term Renal Outcome in Pulmonary Hypertension
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:   18 Years and older   (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 March 1999 and December 2016 at reference center for pulmonary hypertension, University Hospital Giessen, Germany.
Criteria

Inclusion Criteria:

  • older than 18 years
  • subjects with invasively diagnosed pulmonary hypertension at rest and available renal function and spot urine data at day of right heart catheterization between March 1999 and December 2016 at the Department of Pulmonology, University Hospital Giessen and Marburg, Giessen, Germany

Exclusion Criteria:

  • subjects with estimated GFR <15ml/min/1.73m2 or prior dialysis
  • pre-existing acute kidney injury
  • non-end stage renal disease with extracorporeal or peritoneal ultrafiltration due to diuretic-resistant fluid overload
  • primary kidney disease requiring active immunosuppression
  • autosomal dominant polycystic kidney disease
  • if subjects are pregnant
  • if subjects are recipients of solid-organ transplants
  • subjects with pulmonary hypertension with unclear/multifactorial mechanisms (WHO group 5 pulmonary hypertension)

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

Publications of Results:
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Responsible Party: Faeq Husain, Senior Physician Nephrology, University of Giessen
ClinicalTrials.gov Identifier: NCT03045614    
Other Study ID Numbers: AZ 238/16
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Supporting Materials: Study Protocol
Analytic Code
Time Frame: Unlimited
Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Kidney Diseases
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases