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Pulmonary Vascular Disease Phenomics Program PVDOMICS
Pulmonary Vascular Disease Phenomics Program PVDOMICS

NCT02980887

Active Not RecruitingN/A

Sponsor: The Cleveland Clinic

Conditions: Pulmonary Arterial Hypertension

Interventions: No Intervention

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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
Locations (7)
  • Tucson, Arizona, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • New York, New York, United States
  • Valhalla, New York, United States
  • Nashville, Tennessee, United States