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Evaluation of Renal Function in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization

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ClinicalTrials.gov Identifier: NCT03039959
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
Faeq Husain, University of Giessen

Brief Summary:
Evaluation of renal function in patients with pulmonary hypertension undergoing right heart catheterization

Condition or disease Intervention/treatment
Pulmonary Hypertension Diagnostic Test: No intervention

Detailed Description:
Evaluation of renal function, infrarenal hemodynamics and hydration status in patients with pulmonary hypertension undergoing right heart catheterization.

Study Type : Observational [Patient Registry]
Actual Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Evaluation of Renal Function, Intrarenal Hemodynamics, and Neurohormonal Status in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization - A Prospective Cross-sectional Single-center Study
Actual Study Start Date : January 25, 2017
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pulmonary Hypertension
Patient with diagnosed pulmonary hypertension irrespective of WHO class undergoing right heart catherization
Diagnostic Test: No intervention
No intervention




Primary Outcome Measures :
  1. Determination of systemic hemodynamic parameters associated with infrarenal hemodynamics profiles [ Time Frame: At baseline ]

Secondary Outcome Measures :
  1. Differences in renal function in patients with pulmonary hypertension undergoing right heart catheterization [ Time Frame: At baseline ]
  2. Determination of hydration status in patients with pulmonary hypertension [ Time Frame: At baseline ]

Biospecimen Retention:   Samples With DNA
Only residual material will be reserved for the Deutsche Zentrum für Lungenforschung Biobank


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with pulmonary hypertension determined by right heart catheterization
Criteria

Inclusion Criteria:

  • Older than 18 years

Exclusion Criteria:

  • Patients refusing to participate
  • CKD stage 5 with estimated GFR < 15 ml/min/1.73m2
  • Patients with primary kidney disease (e.g., glomerulonephritis, autosomal dominant polycystic kidney disease)
  • Non-end stage renal disease patients with any type of extracorporeal ultrafiltration for treatment of diuretic-resistant fluid overload (e.g., peritoneal ultrafiltration)
  • Deterioration of the patients` clinical condition independent of origin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039959


Locations
Germany
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Investigators
Study Director: Werner Seeger, MD Department of Internal Medicine II; Division of Pulmonology, Nephrology and Critical Care Medicine

Publications of Results:
Responsible Party: Faeq Husain, Senior Physician Nephrology, University of Giessen
ClinicalTrials.gov Identifier: NCT03039959     History of Changes
Other Study ID Numbers: AZ 237/16
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Faeq Husain, University of Giessen:
Chronic Kidney Disease

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases