Clinical trial NCT03039972: Changes in Renal Function and Body Composition in Pulmonary Hypertension
Official title: Prospective Evaluation of Changes in Renal Function and Body Composition in Patients With Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Renal Function Abnormal
Lead sponsor: University of Giessen
Sponsor class: OTHER
First posted: 2017-02-01
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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.

Eligibility 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

Primary outcomes:
measure: Changes in renal function in patients with pulmonary hypertension
timeFrame: 1 year
Secondary outcomes:
measure: Changes in hydration status in patients with pulmonary hypertension
timeFrame: 1 year
measure: Changes in nutritional status in patients with pulmonary hypertension
timeFrame: 1 year
measure: Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: University Clinic Giessen and Marburg - Campus Giessen
state: Hessen
Study officials:
affiliation: Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine
name: Werner Seeger, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
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.10191013. Epub 2014 Feb 27.
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 17;53(7):582-588. doi: 10.1016/j.jacc.2008.08.080.