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 : January 18, 2024
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Condition or disease | Intervention/treatment |
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Pulmonary Arterial Hypertension | Other: No Intervention |
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:
- 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.
- 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 |
Actual Enrollment : | 1195 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 : | December 31, 2029 |
Estimated Study Completion Date : | December 31, 2029 |
Group/Cohort | Intervention/treatment |
---|---|
Controls
Healthy controls No intervention as this is an observational study
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Other: No Intervention
There is no intervention in this observational study |
Pulmonary Vascular Disease
Pulmonary Vascular Disease at risk for pulmonary hypertension
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Other: No Intervention
There is no intervention in this observational study |
Pulmonary Hypertension
Those meeting WSPH/WHO group classifications 1-5 of pulmonary hypertension
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Other: No Intervention
There is no intervention in this observational study |
- Precision based definitions of pulmonary vascular diseases (PVD) [ Time Frame: Over 5 years ]OMICs analyses will be used to assign new class of PVD
- Identification of biomarkers for PVD [ Time Frame: 5 years ]OMICs and other measures of disease
Biospecimen Retention: Samples With DNA
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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 |
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
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
United States, Arizona | |
University of Arizona Health Sciences Center | |
Tucson, Arizona, United States, 85721 | |
United States, Maryland | |
Johns Hopkins University School of Medicine | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Columbia University School of Medicine | |
New York, New York, United States, 10032 | |
Weill Cornell Medicine | |
New York, New York, United States, 10065 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232 |
Study Chair: | Nicholas S Hill, MD | Tufts University Medical Center | |
Study Director: | Lei Xiao, MD | National Heart, Lung, and Blood Institute (NHLBI) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT02980887 |
Other Study ID Numbers: |
16-860 |
First Posted: | December 2, 2016 Key Record Dates |
Last Update Posted: | January 18, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Plan for sharing with outside network investigators is being developed. |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
Time Frame: | Being decided |
Access Criteria: | Being decided |
Pulmonary arterial hypertension |
Pulmonary Arterial Hypertension Hypertension Vascular Diseases Cardiovascular Diseases |
Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases |