Pulmonary Vascular Disease Phenomics Program PVDOMICS

Pulmonary Arterial Hypertension Clinical Trial

— PVDOMICS  

Official title:

Redefining Pulmonary Hypertension Through Pulmonary Vascular Disease Phenomics (PVDOMICS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02980887
• Other study ID #: 16-860
• Status: Active, not recruiting
• Start date: November 2016
• Est. completion date: December 31, 2029

Study information

• Verified date: January 2024
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1195
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Pulmonary Arterial Hypertension
• Vascular Diseases

Intervention

Other:
• No Intervention
There is no intervention in this observational study

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University School of Medicine	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (8)

Lead Sponsor	Collaborator
The Cleveland Clinic	Brigham and Women's Hospital, Columbia University, Johns Hopkins University, Mayo Clinic, University of Arizona, Vanderbilt University, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision based definitions of pulmonary vascular diseases (PVD)	OMICs analyses will be used to assign new class of PVD	Over 5 years
Secondary	Identification of biomarkers for PVD	OMICs and other measures of disease	5 years

External Links

•   PVDOMICS study protocol