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Completed

NCT Number: NCT03039972

Changes in Renal Function and Body Composition in Pulmonary Hypertension

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

Completed

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Renal Function Abnormal Respiratory Tract Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic Giessen and Marburg - Campus Giessen

Giessen, Hesse, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Diagnostic Test

No intervention

Primary outcomes

  1. Changes in renal function in patients with pulmonary hypertension

    Time frame: 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 outcomes

  1. Changes in hydration status in patients with pulmonary hypertension

    Time frame: 1 year

    Bioimpedance analysis will be used to determine hydration status at baseline and at 1 year follow-up

  2. Changes in nutritional status in patients with pulmonary hypertension

    Time frame: 1 year

    Bioimpedance analysis will be used to determine lean tissue and fat mass at baseline and at 1 year follow-up

  3. Prognostic value of baseline renal function, hydration and nutritional status on pulmonary hypertension-associated morbidity and mortality

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Giessen

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 1, 2017
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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