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Pulmonary Vascular Disease Phenomics Program PVDOMICS (PVDOMICS)

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ClinicalTrials.gov Identifier: NCT02980887
Recruitment Status : Active, not recruiting
First Posted : December 2, 2016
Last Update Posted : November 9, 2020
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

Tracking Information
First Submitted Date November 30, 2016
First Posted Date December 2, 2016
Last Update Posted Date November 9, 2020
Study Start Date November 2016
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2016)
Precision based definitions of pulmonary vascular diseases (PVD) [ Time Frame: Over 5 years ]
OMICs analyses will be used to assign new class of PVD
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 30, 2016)
Identification of biomarkers for PVD [ Time Frame: 5 years ]
OMICs and other measures of disease
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pulmonary Vascular Disease Phenomics Program PVDOMICS
Official Title Redefining Pulmonary Hypertension Through Pulmonary Vascular Disease Phenomics (PVDOMICS)
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
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.

A longitudinal study in a subset of the participants enrolled in the parent cross-sectional study will:

  1. Retest participants at a minimum 6 month interval from initial evaluation to collect a core set of clinical and OMICS features. This will include survival, clinical staging, clinical group assignment, 6-minute walk, echocardiography, and blood for a broad collection of selected OMICS tests, to include proteomics and other variables found to be informative in the initial set.
  2. Associate and compare OMICS data with clinical sets and OMICS clusters between baseline and follow-up interval, with attention to reproducibility, predictive capacity as biomarkers for diagnosis, disease progression, phenotypic changes, functional capacity, therapeutic response and survival.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Samples for Omics analyses, including DNA
Sampling Method Non-Probability Sample
Study Population Patients with pulmonary hypertension, Pulmonary hypertension vascular, and healthy controls
Condition Pulmonary Arterial Hypertension
Intervention Other: No Intervention
There is no intervention in this observational study
Study Groups/Cohorts
  • Controls
    Healthy controls No intervention as this is an observational study
    Intervention: Other: No Intervention
  • Pulmonary Vascular Disease
    Pulmonary Vascular Disease at risk for pulmonary hypertension
    Intervention: Other: No Intervention
  • Pulmonary Hypertension
    Those meeting WSPH/WHO group classifications 1-5 of pulmonary hypertension
    Intervention: Other: No Intervention
Publications * Tang WHW, Wilcox JD, Jacob MS, Rosenzweig EB, Borlaug BA, Frantz RP, Hassoun PM, Hemnes AR, Hill NS, Horn EM, Singh HS, Systrom DM, Tedford RJ, Vanderpool RR, Waxman AB, Xiao L, Leopold JA, Rischard FP. Comprehensive Diagnostic Evaluation of Cardiovascular Physiology in Patients With Pulmonary Vascular Disease: Insights From the PVDOMICS Program. Circ Heart Fail. 2020 Mar;13(3):e006363. doi: 10.1161/CIRCHEARTFAILURE.119.006363. Epub 2020 Feb 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: September 26, 2019)
1200
Original Estimated Enrollment
 (submitted: November 30, 2016)
1500
Estimated Study Completion Date September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Cross-sectional (parent) study:

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

Longitudinal study:

Inclusion Criteria:

  • Any PH, comparators or control participant previously enrolled in the parent PVDOMICS protocol with a minimum of six months post-enrollment
  • Dialysis dependent renal function since the parent study acceptable

Exclusion Criteria:

Participant Level 1 (clinic visit):

  • Transplant other than heart or lung
  • In the clinician's opinion, too ill to perform L-PVDOMICS testing even if limited testing.
  • Participants who withdrew from the parent PVDOMICS study
  • Pregnant or nursing
  • Concurrent participation in any investigational drug study or other clinical trial

Participant Level 2 (telephone visit):

  • Transplant other than heart or lung
  • Participants who withdrew from the parent PVDOMICS study

Participant Level 3 (medical chart review):

- Participants who withdrew from the parent PVDOMICS study

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02980887
Other Study ID Numbers 16-860
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Plan for sharing with outside network investigators is being developed.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Being decided
Access Criteria: Being decided
Responsible Party The Cleveland Clinic
Study Sponsor The Cleveland Clinic
Collaborators
  • Brigham and Women's Hospital
  • Columbia University
  • Weill Medical College of Cornell University
  • Johns Hopkins University
  • Mayo Clinic
  • University of Arizona
  • Vanderbilt University
Investigators
Study Chair: Nicholas S Hill, MD Tufts University Medical Center
Study Director: Lei Xiao, MD National Heart, Lung, and Blood Institute (NHLBI)
PRS Account The Cleveland Clinic
Verification Date November 2020