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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02580903
Other study ID # MPNPH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date February 2020

Study information

Verified date September 2020
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational prospective study aiming to clarify the prevalence of pulmonary hypertension in patients with Myeloproliferative Neoplasms and their prognosis.

All patients attending our department with the above mentioned neoplasms will be offered inclusion in this study. All will have an echo performed and patients identified as being at risk of pulmonary hypertension will be offered complete investigation as specified by the European Cardiology Association.

All patients will be followed up for a total of five years to identify prognosis.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date February 2020
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Myeloproliferative Neoplasms (PV, ET, PMF according to WHO classification)

Exclusion Criteria:

- Pregnancy

- Lack of informed consent

- Age < 18 years

- Cognitive dysfunctions

Study Design


Intervention

Radiation:
Radiology
Only a small subsample will require CT and right heart catherisation

Locations

Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)

Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of pulmonary hypertension at initial presentation and first echo Initial recruitment
Secondary Mortality 1 and 5 years
Secondary Incidence of pulmonary hypertension while under follow-up 5 years
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