Pulmonary Vascular Disease Phenomics Program PVDOMICS

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02980887
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

The Cleveland Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nicholas S Hill, MDLei Xiao, MD
Principal Investigator Affiliation Tufts University Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: Controls

Healthy controls No intervention as this is an observational study

: Pulmonary Vascular Disease

Pulmonary Vascular Disease at risk for pulmonary hypertension

: Pulmonary Hypertension

Those meeting WSPH/WHO group classifications 1-5 of pulmonary hypertension

Interventions

Other: - No Intervention

There is no intervention in this observational study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Tucson, Arizona

Status

Address

University of Arizona Health Sciences Center

Tucson, Arizona, 85721

Baltimore, Maryland

Status

Address

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287

Brigham and Women's Hospital, Boston, Massachusetts

Status

Address

Brigham and Women's Hospital

Boston, Massachusetts, 02115

Mayo Clinic, Rochester, Minnesota

Status

Address

Mayo Clinic

Rochester, Minnesota, 55905

Columbia University School of Medicine, New York, New York

Status

Address

Columbia University School of Medicine

New York, New York, 10032

Weill Cornell Medicine, New York, New York

Status

Address

Weill Cornell Medicine

New York, New York, 10065

Vanderbilt University Medical Center, Nashville, Tennessee

Status

Address

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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