Kidney Disease and Pulmonary Hypertension

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 824

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Giessen, Hessen, Germany, 35392
      • University Clinic Giessen and Marburg - Campus Giessen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of pulmonary hypertension-related morbidity on renal function decline	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])	3 years follow-up
Prevalence of proteinuria in pulmonary hypertension	24 hours urine collection at baseline will be assessed to predict progress of pulmonary hypertension	At baseline
Impact of pulmonary hypertension-specific therapy on renal function decline	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	3 years follow-up

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Study Director: Werner Seeger, MD, University Clinic Giessen and Marburg, Campus Giessen

Publications and helpful links

General Publications

• Navaneethan SD, Wehbe E, Heresi GA, Gaur V, Minai OA, Arrigain S, Nally JV Jr, Schold JD, Rahman M, Dweik RA. Presence and outcomes of kidney disease in patients with pulmonary hypertension. Clin J Am Soc Nephrol. 2014 May;9(5):855-63. doi: 10.2215/CJN.10191013. Epub 2014 Feb 27.
• Husain-Syed F, Slutsky AS, Ronco C. Lung-Kidney Cross-Talk in the Critically Ill Patient. Am J Respir Crit Care Med. 2016 Aug 15;194(4):402-14. doi: 10.1164/rccm.201602-0420CP.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): August 27, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: February 4, 2017
• First Submitted That Met QC Criteria: February 4, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Urologic Diseases; Hypertension; Kidney Diseases; Hypertension, Pulmonary
• Other Study ID Numbers: AZ 238/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study are available from the corresponding author upon reasonable request.
• IPD Sharing Time Frame: Unlimited
• IPD Sharing Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No