Kidney Disease and Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045614
• Other study ID #: AZ 238/16
• Status: Completed
• Start date: February 1, 2017
• Est. completion date: August 28, 2018

Study information

• Verified date: November 2019
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 824
• Est. completion date: August 28, 2018
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Kidney Diseases
• Pulmonary Hypertension

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Germany	University Clinic Giessen and Marburg - Campus Giessen	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. Review. — View Citation

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.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Prevalence of proteinuria in pulmonary hypertension	24 hours urine collection at baseline will be assessed to predict progress of pulmonary hypertension	At baseline
Secondary	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