Changes in Renal Function and Body Composition in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

Prospective Evaluation of Changes in Renal Function and Body Composition in Patients With Pulmonary Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039972
• Other study ID #: AZ 239/16
• Status: Completed
• Start date: January 25, 2017
• Est. completion date: July 9, 2020

Study information

• Verified date: December 2020
• Source: University of Giessen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 9, 2020
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Renal Function Abnormal

Intervention

Diagnostic Test:
• No intervention
No intervention

Locations

Country	Name	City	State
Germany	University Clinic Giessen and Marburg - Campus Giessen	Giessen	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
University of Giessen

Country where clinical trial is conducted

Germany, 

References & 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. Review. — View Citation

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 — View Citation

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.10 — View Citation

Ronco C, Verger C, Crepaldi C, Pham J, De Los Ríos 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)†. Nephrol Dial Transplant. 2015 May;30(5):849-58. doi: 10.1093/ndt/gfv013. Epub 2015 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in hydration status in patients with pulmonary hypertension	Bioimpedance analysis will be used to determine hydration status at baseline and at 1 year follow-up	1 year
Secondary	Changes in nutritional status in patients with pulmonary hypertension	Bioimpedance analysis will be used to determine lean tissue and fat mass at baseline and at 1 year follow-up	1 year
Secondary	Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality	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	1 year