Changes in Renal Function and Body Composition in Pulmonary Hypertension

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

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Hypertension; Renal Function Abnormal
• Intervention / Treatment: 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
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Giessen, Hessen, Germany, 35392
      • University Clinic Giessen and Marburg - Campus Giessen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Giessen
• Investigators: Study Director: Werner Seeger, MD, Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2017
• Primary Completion (Actual): October 7, 2019
• Study Completion (Actual): July 9, 2020

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: AZ 239/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No