Changes in Renal Function and Body Composition in Pulmonary Hypertension

NCT03039972 | Completed

• 1 other identifier: AZ 239/16
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Changes in renal function and body composition in patients with pulmonary hypertension

Conditions

Pulmonary Hypertension; Renal Function Abnormal

Outcome Measures

Primary Outcomes (1)

• Changes in renal function in patients with pulmonary hypertension

  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

  1 year

Secondary Outcomes (3)

• Changes in hydration status in patients with pulmonary hypertension

  1 year

• Changes in nutritional status in patients with pulmonary hypertension

  1 year

• Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality

  1 year

Study Arms (1)

Pulmonary Hypertension

Adult outpatients with suspected or prediagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages

Diagnostic Test: No intervention

Interventions

No intervention DIAGNOSTIC_TEST

No intervention

Pulmonary Hypertension

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Giessen: lead

Study Sites (1)

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

Location

Related Publications (4)

• Bellomo R, Prowle JR, Echeverri JE. Diuretic therapy in fluid-overloaded and heart failure patients. Contrib Nephrol. 2010;164:153-163. doi: 10.1159/000313728. Epub 2010 Apr 20.

  PMID: 20428001 BACKGROUND

• Ronco C, Verger C, Crepaldi C, Pham J, De Los Rios T, Gauly A, Wabel P, Van Biesen W; IPOD-PD Study Group. Baseline hydration status in incident peritoneal dialysis patients: the initiative of patient outcomes in dialysis (IPOD-PD study)dagger. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11.

  PMID: 25762355 BACKGROUND

• 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

• Damman K, van Deursen VM, Navis G, Voors AA, van Veldhuisen DJ, Hillege HL. Increased central venous pressure is associated with impaired renal function and mortality in a broad spectrum of patients with cardiovascular disease. J Am Coll Cardiol. 2009 Feb 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080.

  PMID: 19215832 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

  Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician Nephrology

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: February 1, 2017
• Study Start: January 25, 2017
• Primary Completion: October 7, 2019
• Study Completion: July 9, 2020
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 months after publication

Locations

DE (1)