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CompletedNCT03045614Updated Nov 19, 2019

Kidney Disease and Pulmonary Hypertension

An observational study in Pulmonary Hypertension, sponsored by University of Giessen. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by University of Giessen · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
824
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

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In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 824 is above the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

University of Giessen is the lead sponsor of 91 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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)
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
824 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years follow-up

  2. 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)

    Time frame: 3 years follow-up

Secondary outcomes

  1. 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 \[Chronic Kidney Disease Epidemiology Collaboration\])

    Time frame: 3 years follow-up

  2. Prevalence of proteinuria in pulmonary hypertension

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

    Time frame: At baseline

  3. 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

    Time frame: 3 years follow-up

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Study locations

1 site
  • University Clinic Giessen and Marburg - Campus Giessen
    Giessen, Hessen 35392, Germany
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References and documents

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. PubMed 24578332 ↗
  • 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. PubMed 27337068 ↗

Individual participant data

Plan to share: Yes — The data that support the findings of this study are available from the corresponding author upon reasonable request.

Supporting information: Study protocol, Analytic code

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03045614
Lead sponsor
University of Giessen
Responsible party
Faeq Husain (Senior Physician Nephrology, University of Giessen) — Principal investigator
First posted
Feb 7, 2017
Start date
Feb 1, 2017
Primary completion
Aug 27, 2018
Completion
Aug 28, 2018
Last update
Nov 19, 2019

Study contacts

Werner Seeger, MD
study director · University Clinic Giessen and Marburg, Campus Giessen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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