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Completed

NCT Number: NCT03045614

Kidney Disease and Pulmonary Hypertension

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

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Changes in estimated glomerular filtration rate (GFR) in each class of pulmonary hypertension during follow-up period

    Time frame: 3 years follow-up

    Estimated GFR (Chronic Kidney Disease Epidemiology Collaboration) will be used over follow-up period to determine changes in renal function

  2. Impact of renal function on deterioration of pulmonary hypertension during follow-up period

    Time frame: 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 outcomes

  1. Impact of pulmonary hypertension-related morbidity on renal function decline

    Time frame: 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])

  2. Prevalence of proteinuria in pulmonary hypertension

    Time frame: At baseline

    24 hours urine collection at baseline will be assessed to predict progress of pulmonary hypertension

  3. Impact of pulmonary hypertension-specific therapy on renal function decline

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2017
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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