check_circleStudy Completed

Pulmonary hypertension

Bayer Identifier:
20565
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Observational study on residual disease in chronic thromboembolic pulmonary hypertension following pulmonary endarterectomy

Trial purpose

Chronic thromboembolic pulmonary hypertension (CTEPH) is a form of pulmonary hypertension caused by obstruction of the pulmonary vasculature by thromboembolic material and is potentially curable by pulmonary endarterectomy (PEA) surgery. However, in some cases patients may experience recurrent or persistent (residual) disease following PEA.

The proposed study will describe the rates of symptoms and diagnostic procedural claims related to residual disease in CTEPH patients over a two year period following PEA.

The results may help to identify potential gaps in care and to raise awareness of the need to follow-up and screen at risk post-PEA patients for residual disease.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Adults patients ≥ 18 years of age on the index date
    - One claim of pulmonary endarterectomy (PEA) following a claim of pulmonary hypertension (PH) or chronic thromboembolic pulmonary hypertension (CTEPH)
    - ≥ 730 days continuous enrollment post-PEA
  • - Patients under the age of 18
    - Patients with < 730 days of continuous enrollment following the index date

Trial summary

Enrollment Goal
103
Trial Dates
October 2019 - October 2019
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Multipal locationsCleveland, 44195, United States

Primary Outcome

  • The number of patients with recorded symptoms indicative of residual CTEPH, and the proportion of these patients who undergo diagnostic assessments
    Chronic thromboembolic pulmonary hypertension (CTEPH)
    date_rangeTime Frame:
    Two years

Trial design

Residual disease in CTEPH following PEA
Trial Type
Observational
Intervention Type
Diagnostic Test
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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