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Hydration Status and Kidney Disease in Patients With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT03039972
Recruitment Status : Active, not recruiting
First Posted : February 1, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Faeq Husain, University of Giessen

Brief Summary:
Cross-sectional evaluation of hydration status and kidney function in patients with pulmonary hypertension

Condition or disease Intervention/treatment
Pulmonary Hypertension Diagnostic Test: No intervention

Detailed Description:
This cross-sectional study is designed to evaluate the hydration and nutritional status and kidney function in patients with pulmonary hypertension at outpatient clinic via bioimpedance and urine analysis.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 530 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Hydration Status and Kidney Disease in Patients With Pulmonary Hypertension - A Cross-sectional Single-center Study
Actual Study Start Date : January 25, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pulmonary Hypertension
Adult patients with suspected or diagnosed pulmonary hypertension irrespective of subclass and all chronic kidney disease stages
Diagnostic Test: No intervention
No intervention




Primary Outcome Measures :
  1. Longitudinal assessment of fluid overload as measured by bioimpedance analysis in patients with pulmonary hypertension [ Time Frame: 1 year follow-up ]
    Bioimpedance analysis assesses fluid overload as difference between the measured amount of extracellular water and the amount of water expected in normohydrated tissue conditions


Secondary Outcome Measures :
  1. Longitudinal assessment of nutritional status as measured by bioimpedance analysis in patients with pulmonary hypertension [ Time Frame: 1 year follow-up ]
    bioimpedance analysis assesses absolute lean and fat tissue mass

  2. Association of baseline hydration and nutritional status on pulmonary hypertension-related adverse events and mortality [ Time Frame: At baseline ]
    Escalation of pulmonary hypertension-specific therapy and all-cause mortality


Biospecimen Retention:   Samples With DNA
Collection of only residual material (blood, urine) for Deutsche Zentrum für Lungenforschung Biobank


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with diagnosed pulmonary hypertension at outpatient clinic
Criteria

Inclusion Criteria:

  • Older than 18 years

Exclusion Criteria:

  • Patients refusing to participate
  • Deterioration of the patients` clinical condition independent of origin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039972


Locations
Germany
University Clinic Giessen and Marburg - Campus Giessen
Giessen, Hessen, Germany, 35392
Sponsors and Collaborators
University of Giessen
Investigators
Study Director: Werner Seeger, MD Department of Internal Medicine II, Division of Pulmonology, Nephrology and Critical Care Medicine

Publications of Results:
Other Publications:
Responsible Party: Faeq Husain, Senior Physician Nephrology, University of Giessen
ClinicalTrials.gov Identifier: NCT03039972     History of Changes
Other Study ID Numbers: AZ 239/16
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases