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Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure

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ClinicalTrials.gov Identifier: NCT03039959
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Faeq Husain, University of Giessen

Brief Summary:
Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure

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

Detailed Description:
Predictive value of renal venous flow profiles for adverse outcomes in patients with right heart failure. Pulmonary hypertension is the most common precursor for right heart failure, thus represents an ideal scenario to study congestion

Study Type : Observational [Patient Registry]
Actual Enrollment : 205 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Predictive Value of Renal Venous Flow Profiles for Adverse Outcomes in Right Heart Failure
Actual Study Start Date : January 25, 2017
Actual Primary Completion Date : July 15, 2018
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pulmonary Hypertension
Patient with diagnosed pulmonary hypertension irrespective of WHO class undergoing right heart catherization
Diagnostic Test: No intervention
No intervention




Primary Outcome Measures :
  1. Rate of pulmonary hypertension-related morbidity and all-cause mortality [ Time Frame: 1 year post-discharge ]
    Unscheduled hospitalization due to fluid overload, escalation of PH-specific therapy, and death from any cause


Biospecimen Retention:   Samples With DNA
Only residual material will be reserved for the Deutsche Zentrum für Lungenforschung Biobank


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive hospital inpatients with suspected or pre-diagnosed pulmonary hypertension undergoing right heart catheterization
Criteria

Inclusion Criteria:

  • Older than 18 years

Exclusion Criteria:

  • Patients refusing to participate
  • CKD stage 5 (KDIGO)
  • Patients with primary kidney disease (e.g., glomerulonephritis, autosomal dominant polycystic kidney disease, postrenal obstruction)
  • Non-end stage renal disease patients with any type of extracorporeal ultrafiltration for treatment of diuretic-resistant fluid overload (e.g., peritoneal ultrafiltration)
  • Deterioration of the patients` clinical condition independent of origin
  • pre-existing acute kidney injury (as determined by all available serum creatinine values from hospital and outpatient medical records within the previous 90 days)
  • solid-organ transplant recipients
  • use of non-steroidal inflammatory drugs within 72 hours before right heart catheterization

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): NCT03039959


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:
Responsible Party: Faeq Husain, Senior Physician Nephrology, University of Giessen
ClinicalTrials.gov Identifier: NCT03039959     History of Changes
Other Study ID Numbers: AZ 237/16
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 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

Keywords provided by Faeq Husain, University of Giessen:
Chronic Kidney Disease

Additional relevant MeSH terms:
Heart Failure
Hypertension, Pulmonary
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases