Pulmonary Arterial HypertensionPVDOMICSNCT02980887
Pulmonary Vascular Disease Phenomics Program PVDOMICS
An observational study of Pulmonary Arterial Hypertension, run by The Cleveland Clinic at 7 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- How many people
- 1,195 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2016to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with pulmonary hypertension, Pulmonary hypertension vascular, and healthy controls
Who may be able to join
- 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
- 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
Who cannot join
- Dialysis dependent renal function; In the clinician's opinion, too ill to perform the protocol testing; Pregnant or nursing
- Longitudinal study:
- 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
Show all 13Show fewer
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Weill Cornell Medicine
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
University of Arizona Health Sciences Center
Tucson, Arizona, 85721
New York Medical College
Valhalla, New York, 10595
About this study
Official title: Redefining Pulmonary Hypertension Through Pulmonary Vascular Disease Phenomics (PVDOMICS)
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
Read the 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:
- 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- No Intervention
- Keywords
- Pulmonary arterial hypertension
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
There is no intervention in this observational study
| Study group | Role | What they receive |
|---|---|---|
| Controls | Healthy controls No intervention as this is an observational study Receives: Other: No Intervention | |
| Pulmonary Vascular Disease | Pulmonary Vascular Disease at risk for pulmonary hypertension Receives: Other: No Intervention | |
| Pulmonary Hypertension | Those meeting WSPH/WHO group classifications 1-5 of pulmonary hypertension Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision based definitions of pulmonary vascular diseases (PVD)
OMICs analyses will be used to assign new class of PVD
Measured: Over 5 years
Secondary outcomes (1)
Identification of biomarkers for PVD
OMICs and other measures of disease
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,195 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Columbia University, Weill Medical College of Cornell University, Johns Hopkins University, Mayo Clinic, University of Arizona, Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Nicholas S Hill, MD, Study chair, Tufts University Medical CenterLei Xiao, MD, Study director, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980887
- Sponsor's protocol ID
- 16-860
- Acronym
- PVDOMICS
- Status last verified
- Sep 2026
- First submitted
- 30 Nov 2016
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan for sharing with outside network investigators is being developed. Data will be archived at BioLINCC and BioDataCatalyst.
Publications
Hemnes AR, Leopold JA, Radeva MK, Beck GJ, Abidov A, Aldred MA, Barnard J, Rosenzweig EB, Borlaug BA, Chung WK, Comhair SAA, Desai AA, Dubrock HM, Erzurum SC, Finet JE, Frantz RP, Garcia JGN, Geraci MW, Gray MP, Grunig G, Hassoun PM, Highland KB, Hill NS, Hu B, Kwon DH, Jacob MS, Jellis CL, Larive AB, Lempel JK, Maron BA, Mathai SC, McCarthy K, Mehra R, Nawabit R, Newman JH, Olman MA, Park MM, Ramos JA, Renapurkar RD, Rischard FP, Sherer SG, Tang WHW, Thomas JD, Vanderpool RR, Waxman AB, Wilcox JD, Yuan JX, Horn EM; PVDOMICS Study Group. Clinical Characteristics and Transplant-Free Survival Across the Spectrum of Pulmonary Vascular Disease. J Am Coll Cardiol. 2022 Aug 16;80(7):697-718. doi: 10.1016/j.jacc.2022.05.038.
PubMed 35953136Hemnes AR, Beck GJ, Newman JH, Abidov A, Aldred MA, Barnard J, Berman Rosenzweig E, Borlaug BA, Chung WK, Comhair SAA, Erzurum SC, Frantz RP, Gray MP, Grunig G, Hassoun PM, Hill NS, Horn EM, Hu B, Lempel JK, Maron BA, Mathai SC, Olman MA, Rischard FP, Systrom DM, Tang WHW, Waxman AB, Xiao L, Yuan JX, Leopold JA; PVDOMICS Study Group. PVDOMICS: A Multi-Center Study to Improve Understanding of Pulmonary Vascular Disease Through Phenomics. Circ Res. 2017 Oct 27;121(10):1136-1139. doi: 10.1161/CIRCRESAHA.117.311737.
PubMed 29074534Tang 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.
PubMed 32088984Jellis CL, Park MM, Abidov A, Borlaug BA, Brittain EL, Frantz R, Hassoun PM, Horn EM, Jaber WA, Jiwon K, Karas MG, Kwon D, Leopold JA, Maron B, Mathai SC, Mehra R, Rischard F, Rosenzweig EB, Tang WHW, Vanderpool R, Thomas JD; PVDOMICS Study Group. Comprehensive echocardiographic evaluation of the right heart in patients with pulmonary vascular diseases: the PVDOMICS experience. Eur Heart J Cardiovasc Imaging. 2022 Jun 21;23(7):958-969. doi: 10.1093/ehjci/jeab065.
PubMed 34097027Farha S, Hu B, Chen R, Barnard J, Comhair S, Heresi G, Parambil J, Tonelli A, Beck G, Berman-Rosenzweig E, DuBrock H, Finet JE, Frantz RP, Grunig G, Hassoun PM, Hemnes AR, Hill N, Horn E, Jellis C, Leopold JA, Park MM, Rischard FP, Simpson C, Tang WHW, Olman MA, Erzurum SC, Dweik RA; PVDOMICS Study Group. Endotypes of Vascular Health Predict Transplantation-Free Survival in Pulmonary Hypertension. J Am Heart Assoc. 2026 Jul 21;15(14):e048795. doi: 10.1161/JAHA.125.048795. Epub 2026 Jul 17.
PubMed 42466490Reddy YNV, Frantz RP, Egbe AC, Miranda WR, Asokan AK, Hassoun PM, Hemnes AR, Horn E, Leopold JA, Rischard F, Rosenzweig EB, Hill NS, Erzurum SC, Finet JE, Mukherjee M, Tang WHW, Nair KS, Borlaug BA. Phenotypic Characterization of Unclassified Pulmonary Hypertension. Circ Heart Fail. 2026 Jul;19(7):e014480. doi: 10.1161/CIRCHEARTFAILURE.125.014480. Epub 2026 Jun 19.
PubMed 42318624Menon DP, Frantz RP, Gochanour BR, Beck GJ, Berman-Rosenzweig ES, Borlaug BA, Erzurum SC, Farha S, Finet JE, Grunig G, Hassoun PM, Hemnes AR, Hill NS, Horn EM, Lempel JK, Leopold JA, Mathai SC, Renapurkar RD, Rischard FP, Waxman AB, DuBrock HM. Ground-Glass Opacities in Pulmonary Arterial Hypertension-Results from the PVDOMICS Study. Ann Am Thorac Soc. 2025 Dec;22(12):1863-1873. doi: 10.1513/AnnalsATS.202503-333OC.
PubMed 40680159Reddy YNV, Frantz RP, Hemnes AR, Hassoun PM, Horn E, Leopold JA, Rischard F, Rosenzweig EB, Hill NS, Erzurum SC, Beck GJ, Finet JE, Jellis CL, Mathai SC, Tang WHW, Borlaug BA; PVDOMICS Study Group. Disentangling the Impact of Adiposity From Insulin Resistance in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2025 May 13;85(18):1774-1788. doi: 10.1016/j.jacc.2025.03.530.
PubMed 40335254Borlaug BA, Larive B, Frantz RP, Hassoun P, Hemnes A, Horn E, Leopold J, Rischard F, Berman-Rosenzweig E, Beck G, Erzurum S, Farha S, Finet JE, Highland KB, Jacob M, Jellis C, Mehra R, Renapurkar R, Singh H, Tang WHW, Vanderpool R, Wilcox J, Yu S, Hill N. Pulmonary hypertension across the spectrum of left heart and lung disease. Eur J Heart Fail. 2024 Jul;26(7):1642-1651. doi: 10.1002/ejhf.3302. Epub 2024 Jun 4.
PubMed 38837273Lowery MM, Hill NS, Wang L, Rosenzweig EB, Bhat A, Erzurum S, Finet JE, Jellis CL, Kaur S, Kwon DH, Nawabit R, Radeva M, Beck GJ, Frantz RP, Hassoun PM, Hemnes AR, Horn EM, Leopold JA, Rischard FP, Mehra R; Pulmonary Vascular Disease Phenomics (PVDOMICS) Study Group. Sleep-Related Hypoxia, Right Ventricular Dysfunction, and Survival in Patients With Group 1 Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2023 Nov 21;82(21):1989-2005. doi: 10.1016/j.jacc.2023.09.806.
PubMed 37968017
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redefining Pulmonary Hypertension Through Pulmonary Vascular Disease Phenomics (PVDOMICS)
- ClinicalTrials.gov ID
- NCT02980887
- Acronym / sponsor ID
- PVDOMICS / 16-860
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary arterial hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,195 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Columbia University, Weill Medical College of Cornell University, Johns Hopkins University, Mayo Clinic, University of Arizona, Vanderbilt University
- Study start
- Nov 2016
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controls | – | Other: No InterventionHealthy controls No intervention as this is an observational study |
| Pulmonary Vascular Disease | – | Other: No InterventionPulmonary Vascular Disease at risk for pulmonary hypertension |
| Pulmonary Hypertension | – | Other: No InterventionThose meeting WSPH/WHO group classifications 1-5 of pulmonary hypertension |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary hypertension, Pulmonary hypertension vascular, and healthy controls
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (13 listed)
- Dialysis dependent renal function; In the clinician's opinion, too ill to perform the protocol testing; Pregnant or nursing
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThere is no intervention in this observational study | Other | Controls, Pulmonary Hypertension, Pulmonary Vascular Disease |
Primary outcome
Precision based definitions of pulmonary vascular diseases (PVD)
Time frame: Over 5 years
OMICs analyses will be used to assign new class of PVD
1 secondary outcome
Identification of biomarkers for PVD
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 35953136Hemnes AR, Leopold JA, Radeva MK, Beck GJ, Abidov A, Aldred MA, Barnard J, Rosenzweig EB, Borlaug BA, Chung WK, Comhair SAA, Desai AA, Dubrock HM, Erzurum SC, Finet JE, Frantz RP, Garcia JGN, Geraci MW, Gray MP, Grunig G, Hassoun PM, Highland KB, Hill NS, Hu B, Kwon DH, Jacob MS, Jellis CL, Larive AB, Lempel JK, Maron BA, Mathai SC, McCarthy K, Mehra R, Nawabit R, Newman JH, Olman MA, Park MM, Ramos JA, Renapurkar RD, Rischard FP, Sherer SG, Tang WHW, Thomas JD, Vanderpool RR, Waxman AB, Wilcox JD, Yuan JX, Horn EM; PVDOMICS Study Group. Clinical Characteristics and Transplant-Free Survival Across the Spectrum of Pulmonary Vascular Disease. J Am Coll Cardiol. 2022 Aug 16;80(7):697-718. doi: 10.1016/j.jacc.2022.05.038.
- Background: PubMed 29074534Hemnes AR, Beck GJ, Newman JH, Abidov A, Aldred MA, Barnard J, Berman Rosenzweig E, Borlaug BA, Chung WK, Comhair SAA, Erzurum SC, Frantz RP, Gray MP, Grunig G, Hassoun PM, Hill NS, Horn EM, Hu B, Lempel JK, Maron BA, Mathai SC, Olman MA, Rischard FP, Systrom DM, Tang WHW, Waxman AB, Xiao L, Yuan JX, Leopold JA; PVDOMICS Study Group. PVDOMICS: A Multi-Center Study to Improve Understanding of Pulmonary Vascular Disease Through Phenomics. Circ Res. 2017 Oct 27;121(10):1136-1139. doi: 10.1161/CIRCRESAHA.117.311737.
- Background: PubMed 32088984Tang 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.
- Background: PubMed 34097027Jellis CL, Park MM, Abidov A, Borlaug BA, Brittain EL, Frantz R, Hassoun PM, Horn EM, Jaber WA, Jiwon K, Karas MG, Kwon D, Leopold JA, Maron B, Mathai SC, Mehra R, Rischard F, Rosenzweig EB, Tang WHW, Vanderpool R, Thomas JD; PVDOMICS Study Group. Comprehensive echocardiographic evaluation of the right heart in patients with pulmonary vascular diseases: the PVDOMICS experience. Eur Heart J Cardiovasc Imaging. 2022 Jun 21;23(7):958-969. doi: 10.1093/ehjci/jeab065.
- Derived from this study: PubMed 42466490Farha S, Hu B, Chen R, Barnard J, Comhair S, Heresi G, Parambil J, Tonelli A, Beck G, Berman-Rosenzweig E, DuBrock H, Finet JE, Frantz RP, Grunig G, Hassoun PM, Hemnes AR, Hill N, Horn E, Jellis C, Leopold JA, Park MM, Rischard FP, Simpson C, Tang WHW, Olman MA, Erzurum SC, Dweik RA; PVDOMICS Study Group. Endotypes of Vascular Health Predict Transplantation-Free Survival in Pulmonary Hypertension. J Am Heart Assoc. 2026 Jul 21;15(14):e048795. doi: 10.1161/JAHA.125.048795. Epub 2026 Jul 17.
- Derived from this study: PubMed 42318624Reddy YNV, Frantz RP, Egbe AC, Miranda WR, Asokan AK, Hassoun PM, Hemnes AR, Horn E, Leopold JA, Rischard F, Rosenzweig EB, Hill NS, Erzurum SC, Finet JE, Mukherjee M, Tang WHW, Nair KS, Borlaug BA. Phenotypic Characterization of Unclassified Pulmonary Hypertension. Circ Heart Fail. 2026 Jul;19(7):e014480. doi: 10.1161/CIRCHEARTFAILURE.125.014480. Epub 2026 Jun 19.
- Derived from this study: PubMed 40680159Menon DP, Frantz RP, Gochanour BR, Beck GJ, Berman-Rosenzweig ES, Borlaug BA, Erzurum SC, Farha S, Finet JE, Grunig G, Hassoun PM, Hemnes AR, Hill NS, Horn EM, Lempel JK, Leopold JA, Mathai SC, Renapurkar RD, Rischard FP, Waxman AB, DuBrock HM. Ground-Glass Opacities in Pulmonary Arterial Hypertension-Results from the PVDOMICS Study. Ann Am Thorac Soc. 2025 Dec;22(12):1863-1873. doi: 10.1513/AnnalsATS.202503-333OC.
- Derived from this study: PubMed 40335254Reddy YNV, Frantz RP, Hemnes AR, Hassoun PM, Horn E, Leopold JA, Rischard F, Rosenzweig EB, Hill NS, Erzurum SC, Beck GJ, Finet JE, Jellis CL, Mathai SC, Tang WHW, Borlaug BA; PVDOMICS Study Group. Disentangling the Impact of Adiposity From Insulin Resistance in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2025 May 13;85(18):1774-1788. doi: 10.1016/j.jacc.2025.03.530.
- Derived from this study: PubMed 38837273Borlaug BA, Larive B, Frantz RP, Hassoun P, Hemnes A, Horn E, Leopold J, Rischard F, Berman-Rosenzweig E, Beck G, Erzurum S, Farha S, Finet JE, Highland KB, Jacob M, Jellis C, Mehra R, Renapurkar R, Singh H, Tang WHW, Vanderpool R, Wilcox J, Yu S, Hill N. Pulmonary hypertension across the spectrum of left heart and lung disease. Eur J Heart Fail. 2024 Jul;26(7):1642-1651. doi: 10.1002/ejhf.3302. Epub 2024 Jun 4.
- Derived from this study: PubMed 37968017Lowery MM, Hill NS, Wang L, Rosenzweig EB, Bhat A, Erzurum S, Finet JE, Jellis CL, Kaur S, Kwon DH, Nawabit R, Radeva M, Beck GJ, Frantz RP, Hassoun PM, Hemnes AR, Horn EM, Leopold JA, Rischard FP, Mehra R; Pulmonary Vascular Disease Phenomics (PVDOMICS) Study Group. Sleep-Related Hypoxia, Right Ventricular Dysfunction, and Survival in Patients With Group 1 Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2023 Nov 21;82(21):1989-2005. doi: 10.1016/j.jacc.2023.09.806.
- PVDOMICS study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Plan for sharing with outside network investigators is being developed. Data will be archived at BioLINCC and BioDataCatalyst.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas S Hill, MD study chair
Tufts University Medical Center
Lei Xiao, MD study director
National Heart, Lung, and Blood Institute (NHLBI)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by The Cleveland Clinic at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision based definitions of pulmonary vascular diseases (PVD) (time frame: Over 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980887, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.