Kidney Disease and Pulmonary Hypertension

NCT03045614 | Completed

• 1 other identifier: AZ 238/16
• Study Type: observational
• Target: 824
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Impact of pulmonary hypertension-related morbidity on renal function decline

  3 years follow-up

• Prevalence of proteinuria in pulmonary hypertension

  At baseline

• Impact of pulmonary hypertension-specific therapy on renal function decline

  3 years follow-up

Interventions

No intervention OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

Location

Related Publications (2)

• 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.

  PMID: 24578332 RESULT

• 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.

  PMID: 27337068 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Collection of only residual material (blood, urine) for Deutsche Zentrum für Lungenforschung Biobank.

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Werner Seeger, MD

  University Clinic Giessen and Marburg, Campus Giessen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician Nephrology

Study Record Dates

• First Submitted: February 4, 2017
• First Posted: February 7, 2017
• Study Start: February 1, 2017
• Primary Completion: August 27, 2018
• Study Completion: August 28, 2018
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Unlimited
• Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Locations

DE (1)