Kidney Disease and Pulmonary Hypertension

Completed

• Conditions: Pulmonary Hypertension

• Registration Number: NCT03045614
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-04
• Study First Submitted QC: 2017-02-04
• Study First Posted: 2017-02-07
• Primary Completion: 2018-08-27
• Study Completion: 2018-08-28
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-17
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 824

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in estimated glomerular filtration rate (GFR) in each class of pulmonary hypertension during follow-up period	3 years follow-up	Estimated GFR (Chronic Kidney Disease Epidemiology Collaboration) will be used over follow-up period to determine changes in renal function
Impact of renal function on deterioration of pulmonary hypertension during follow-up period	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

Name	Time	Method
Impact of pulmonary hypertension-related morbidity on renal function decline	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 \[Chronic Kidney Disease Epidemiology Collaboration\])
Impact of pulmonary hypertension-specific therapy on renal function decline	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
Prevalence of proteinuria in pulmonary hypertension	At baseline	24 hours urine collection at baseline will be assessed to predict progress of pulmonary hypertension

Trial Locations

Locations (1)

University Clinic Giessen and Marburg - Campus Giessen; 🇩🇪 Giessen, Hessen, Germany