Changes in Renal Function and Body Composition in Pulmonary Hypertension

Completed

• Conditions: Pulmonary Hypertension; Renal Function Abnormal
• Interventions: Diagnostic Test: No intervention

• Registration Number: NCT03039972
• Lead Sponsor: University of 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.

Study Timeline

• Study Start: 2017-01-25
• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Primary Completion: 2019-10-07
• Study Completion: 2020-07-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary Hypertension	No intervention	Adult outpatients with suspected or prediagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages

Primary Outcome Measures

Name	Time	Method
Changes in renal function in patients with pulmonary hypertension	1 year	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

Secondary Outcome Measures

Name	Time	Method
Changes in nutritional status in patients with pulmonary hypertension	1 year	Bioimpedance analysis will be used to determine lean tissue and fat mass at baseline and at 1 year follow-up
Changes in hydration status in patients with pulmonary hypertension	1 year	Bioimpedance analysis will be used to determine hydration status at baseline and at 1 year follow-up
Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality	1 year	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

Trial Locations

Locations (1)

University Clinic Giessen and Marburg - Campus Giessen; 🇩🇪 Giessen, Hessen, Germany