Trial record 16 of 1217 for:    pulmonary hypertension

Pulmonary Hypertension in Patients With Myeloproliferative Neoplasms (MPNPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02580903
Recruitment Status : Recruiting
First Posted : October 20, 2015
Last Update Posted : October 20, 2015
Information provided by (Responsible Party):
Mette Brabrand, Odense University Hospital

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.

Condition or disease Intervention/treatment
Myeloproliferative Disorders Pulmonary Hypertension Radiation: Radiology

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmonary Hypertension in Patients With Philadelphia Chromosome Negative Myeloproliferative Neoplasms; an Observational Prospective Study
Study Start Date : February 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Prevalence of pulmonary hypertension at initial presentation and first echo [ Time Frame: Initial recruitment ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 1 and 5 years ]
  2. Incidence of pulmonary hypertension while under follow-up [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
All patients will submit a blood sample for later analysis

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients attending our outpatient clinic with Myeloproliferative Neoplasms

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02580903

Contact: Mette Brabrand, MD +4566113333
Contact: Hanne Vestergaard, MD PhD +4566113333

Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Mette Brabrand, MD    +4566113333   
Sponsors and Collaborators
Odense University Hospital
Principal Investigator: Mette Brabrand, MD Odense University Hospital

Responsible Party: Mette Brabrand, Staff Specialist, Odense University Hospital Identifier: NCT02580903     History of Changes
Other Study ID Numbers: MPNPH
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Hypertension, Pulmonary
Myeloproliferative Disorders
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Bone Marrow Diseases
Hematologic Diseases