Clinical trial NCT03045614: Kidney Disease and Pulmonary Hypertension
Official title: Prevalence and Predictors of Kidney Disease, and Long-Term Renal Outcome in Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 824
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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)

Primary outcomes:
measure: Changes in estimated glomerular filtration rate (GFR) in each class of pulmonary hypertension during follow-up period
timeFrame: 3 years follow-up
measure: Impact of renal function on deterioration of pulmonary hypertension during follow-up period
timeFrame: 3 years follow-up
Secondary outcomes:
measure: Impact of pulmonary hypertension-related morbidity on renal function decline
timeFrame: 3 years follow-up
measure: Prevalence of proteinuria in pulmonary hypertension
timeFrame: At baseline
measure: Impact of pulmonary hypertension-specific therapy on renal function decline
timeFrame: 3 years follow-up
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University Clinic Giessen and Marburg - Campus Giessen
state: Hessen
Study officials:
affiliation: University Clinic Giessen and Marburg, Campus Giessen
name: Werner Seeger, MD
role: STUDY_DIRECTOR
References:
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.10191013. Epub 2014 Feb 27.
citation: 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.