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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 : August 31, 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 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 during right heart catheterization and long-term renal outcome in patients with pulmonary hypertension.

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. Classification of hemodynamic parameters measured at time-point of right heart catheterization according to kidney function stages 1-5. [ Time Frame: At baseline ]
  2. Mortality of patients with pulmonary hypertension during follow-up period based on kidney function stages 1-5 measured at time-point of right heart catheterization. [ Time Frame: 3 years follow-up ]
  3. Estimated GFR decline in each class of pulmonary hypertension during follow-up period [ Time Frame: 3 years follow-up ]
  4. Predictive value of central venous pressure and b-type natriuretic peptide at time of right heart catheterization for development of chronic kidney disease. [ Time Frame: 3 years follow-up ]

Secondary Outcome Measures :
  1. Prevalence of diuretics in patients with pulmonary hypertension at time of right heart catheterization. [ Time Frame: At baseline ]

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 diagnosed PH undergoing right heart catheterization between 1999 and 2013
Criteria

Inclusion Criteria:

  • Older than 18 years

Exclusion Criteria:

  • Patients with estimated GFR < 15ml/min or with chronic dialysis treatment

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, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine

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: August 31, 2018
Last Verified: August 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