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Pulmonary Vascular Disease Phenomics Program PVDOMICS (PVDOMICS)

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ClinicalTrials.gov Identifier: NCT02980887
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : February 22, 2019
Sponsor:
Collaborators:
Brigham and Women's Hospital
Columbia University
Weill Medical College of Cornell University
Johns Hopkins University
Mayo Clinic
University of Arizona
Vanderbilt University
Information provided by (Responsible Party):
The Cleveland Clinic

Brief Summary:
It is recognized that patients with various forms of heart and lung disease exhibit varying degrees of pulmonary hypertension, pulmonary vascular remodeling, and right ventricular dysfunction. The genetic, molecular, and cellular processes driving these phenomena are not well understood. Rapid advances in high throughput omic methodology, combined with powerful bioinformatics and network biology capability, have created the opportunity to conduct studies that broadly search for homologies and differences across the spectrum of disease states associated with pulmonary hypertension, and determinants of the spectrum of right ventricular compensation that accompanies these conditions

Condition or disease Intervention/treatment
Pulmonary Arterial Hypertension Other: No Intervention

Detailed Description:
The protocol is designed to lead to new understanding of patients with pulmonary hypertension and right heart dysfunction, based on molecular, clinical, hemodynamic and radiographic characteristics. New classifications will be a product of association of these in depth phenotypic descriptions with specific molecular mechanisms of pathogenesis. The protocol will be implemented to lead to identification of both sub-phenotypes of lung vascular disease and to biomarkers of disease that may be useful for early diagnosis or for assessment of interventions to prevent or treat this condition.

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Redefining Pulmonary Hypertension Through Pulmonary Vascular Disease Phenomics (PVDOMICS)
Study Start Date : November 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021


Group/Cohort Intervention/treatment
Controls
Healthy controls No intervention as this is an observational study
Other: No Intervention
There is no intervention in this observational study

Pulmonary Vascular Disease
Pulmonary Vascular Disease at risk for pulmonary hypertension
Other: No Intervention
There is no intervention in this observational study

Pulmonary Hypertension
Those meeting WHO group classifications 1-5 of pulmonary hypertension
Other: No Intervention
There is no intervention in this observational study




Primary Outcome Measures :
  1. Precision based definitions of pulmonary vascular diseases (PVD) [ Time Frame: Over 5 years ]
    OMICs analyses will be used to assign new class of PVD


Secondary Outcome Measures :
  1. Identification of biomarkers for PVD [ Time Frame: 5 years ]
    OMICs and other measures of disease


Biospecimen Retention:   Samples With DNA
Samples for Omics analyses, including DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with pulmonary hypertension, Pulmonary hypertension vascular, and healthy controls
Criteria

Inclusion Criteria:

Patients ages >18 years of age referred for right heart catheterization for further evaluation of known PVD or to be at risk for PVD due to established cardiac disease or pulmonary disease

  • Able to perform complete diagnostic testing listed subsequently (cardiac catheterization, echo, exercise test, PFT's, ECG, chest CT, quality of life questionnaires, ventilation/perfusion scan, cardiac MRI, body composition bioimpedance, and sleep study)
  • Subject signs informed consent to perform required testing for the protocol

Exclusion Criteria:

Dialysis dependent renal function; In the clinician's opinion, too ill to perform the protocol testing; Pregnant or nursing


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): NCT02980887


Contacts
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Contact: Serpil C Erzurum, MD 216-445-6624 erzurus@ccf.org
Contact: Gerald J Beck, PhD 216-444-9927 beckg@ccf.org

Locations
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United States, Arizona
University of Arizona Health Sciences Center Recruiting
Tucson, Arizona, United States, 85721
Contact: Franz Rischard, MD    520-626-6380    frischard@deptofmed.arizona.edu   
Contact: Heidi Erickson, RN    520-626-5287    herickso@email.arizona.edu   
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Paul Hassoun, MD    410-614-5158    phassoun@jhmi.edu   
Contact: Blessing Enobun    410-502-4362    benobun1@jhu.edu   
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jane Leopold, MD    617-525-4846    jleopold@partners.org   
Contact: Laurie Lawler, RN    617-525-9731    llawler@bwh.harvard.edu   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Robert Frantz, MD    507-284-4072    frantz.robert@mayo.edu   
Contact: Kristal Rohwer    507-255-8923    rohwer.kristal@mayo.edu   
United States, New York
Columbia University School of Medicine Recruiting
New York, New York, United States, 10032
Contact: Erika Berman-Rosenzweig, MD    212-305-4436    esb14@cumc.columbia.edu   
Contact: Aisha Banks, CRC    212-342-1456    ab3696@cumc.columbia.edu   
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Evelyn Horn, MD    212-746-2381    horneve@med.cornell.edu   
Contact: Melissa Ricketts, MS    212-746 - 2698    mdr2001@med.cornell.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Anna Hemnes, MD    615-343-8227    anna.r.hemnes@vanderbilt.edu   
Contact: Errine Garnett, BS    615-343-4252    errine.t.garnett@vanderbilt.edu   
Sponsors and Collaborators
The Cleveland Clinic
Brigham and Women's Hospital
Columbia University
Weill Medical College of Cornell University
Johns Hopkins University
Mayo Clinic
University of Arizona
Vanderbilt University
Investigators
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Study Chair: Nicholas S Hill, MD Tufts University Medical Center
Study Director: Lei Xiao, MD National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02980887     History of Changes
Other Study ID Numbers: 16-860
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by The Cleveland Clinic:
Pulmonary arterial hypertension
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases