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Changes in Renal Function and Body Composition in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03039972
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Faeq Husain, University of Giessen

Brief Summary:
Changes in renal function and body composition in patients with pulmonary hypertension

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

Detailed Description:
This prospective single-center study is designed to analyze changes in renal function and body composition in patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Prospective Evaluation of Changes in Renal Function and Body Composition in Patients With Pulmonary Hypertension
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pulmonary Hypertension
Adult outpatients with suspected or prediagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages
Diagnostic Test: No intervention
No intervention




Primary Outcome Measures :
  1. Changes in renal function in patients with pulmonary hypertension [ Time Frame: 1 year ]
    Estimated GFR based on Chronic Kidney Disease Epidemiology Collaboration-creatinine-cystatin C will be used to determine renal function at baseline and at 1 year follow-up


Secondary Outcome Measures :
  1. Changes in hydration status in patients with pulmonary hypertension [ Time Frame: 1 year ]
    Bioimpedance analysis will be used to determine hydration status at baseline and at 1 year follow-up

  2. Changes in nutritional status in patients with pulmonary hypertension [ Time Frame: 1 year ]
    Bioimpedance analysis will be used to determine lean tissue and fat mass at baseline and at 1 year follow-up

  3. Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality [ Time Frame: 1 year ]
    pulmonary hypertension-associated morbidity and mortality (defined as escalation of pulmonary hypertension-specific therapy, unscheduled hospitalization and all-cause mortality) will be prospectively assessed during follow-up period


Biospecimen Retention:   Samples With DNA
Collection of only residual material (blood, urine) for Deutsche Zentrum für Lungenforschung Biobank.


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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
All patients with suspected or pre-diagnosed pulmonary hypertension at pulmonary hypertension outpatient clinic, University Hospital Giessen and Marburg, Campus Giessen
Criteria

Inclusion Criteria:

  • Subjects older than 18 years at pulmonary hypertension outpatient clinic
  • Subjects who signed informed consent forms

Exclusion Criteria:

  • Patients refusing to participate or withdraw consent during follow-up

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): NCT03039972


Contacts
Contact: Faeq Husain-Syed, MD +49 641 985 42378 ext 986 56873 faeq.husain-syed@innere.med.uni-giessen.de
Contact: Henning Gall, MD +49 641 985 42351 henning.gall@innere.med.uni-giessen.de

Locations
Germany
University Clinic Giessen and Marburg - Campus Giessen Recruiting
Giessen, Hessen, Germany, 35392
Contact: Faeq Husain-Syed, MD    +49 641 985 42378    faeq.husain-syed@innere.med.uni-giessen.de   
Contact: Henning Gall, MD    +49 641 985 42351    henning.gall@innere.med.uni-giessen.de   
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:
Other Publications:
Responsible Party: Faeq Husain, Senior Physician Nephrology, University of Giessen
ClinicalTrials.gov Identifier: NCT03039972     History of Changes
Other Study ID Numbers: AZ 239/16
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
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

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