Pulmonary Hypertension Clinical Trial
Official title:
Prospective Evaluation of Changes in Renal Function and Body Composition in Patients With Pulmonary Hypertension
NCT number | NCT03039972 |
Other study ID # | AZ 239/16 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 25, 2017 |
Est. completion date | July 9, 2020 |
Verified date | December 2020 |
Source | University of Giessen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Changes in renal function and body composition in patients with pulmonary hypertension
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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Clinic Giessen and Marburg - Campus Giessen | Giessen | Hessen |
Lead Sponsor | Collaborator |
---|---|
University of Giessen |
Germany,
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
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 |
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