NCT02580903

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 years

First QC Date

January 31, 2015

Last Update Submit

September 15, 2020

Conditions

Myeloproliferative DisordersPulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Prevalence of pulmonary hypertension at initial presentation and first echo

    Initial recruitment

Secondary Outcomes (2)

  • Mortality

    1 and 5 years

  • Incidence of pulmonary hypertension while under follow-up

    5 years

Interventions

RadiologyRADIATION

Only a small subsample will require CT and right heart catherisation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending our outpatient clinic with Myeloproliferative Neoplasms

You may qualify if:

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

You may not qualify if:

  • Pregnancy
  • Lack of informed consent
  • Age \< 18 years
  • Cognitive dysfunctions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All patients will submit a blood sample for later analysis

MeSH Terms

Conditions

Myeloproliferative DisordersHypertension, Pulmonary

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Mette Brabrand, MD

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Specialist

Study Record Dates

First Submitted

January 31, 2015

First Posted

October 20, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

DK(1)