Status:
COMPLETED
BMPR2 Mutations and Iron Metabolism in Pulmonary Arterial Hypertension
Lead Sponsor:
Heidelberg University
Collaborating Sponsors:
University Hospital Heidelberg
Hannover Medical School
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-80 years
Brief Summary
Previously characterised PAH patients, including idiopathic, heritable and other forms of group 1 PAH with and without BMPR2 mutation which have already been analysed and are regularly seen in the Cen...
Detailed Description
Pulmonary arterial hypertension (PAH) is a rare disease characterized by an increase in pulmonary arterial pressure and pulmonary vascular resistance, which result in right heart hypertrophy and decom...
Eligibility Criteria
Inclusion
- Inclusion Criteria Patients:
- Informed consent
- Male or female PAH, including idiopathic, heritable and other forms of group 1 PAH (according to Nice classification) patients 18-80 years of age
- Invasively diagnosed PAH by right heart catheter (invasively confirmed diagnosis according to the current PAH definition of valid guidelines at time of initial diagnosis)
- Optimized medical therapy for PAH (such as endothelin-receptor-antagonists, inhaled prostanoids, phosphodiesterase-5-inhibitors, diuretics and if useful, supplemental oxygen) for at least 2 months before entering the study
- Able to understand and willing to sign the Informed Consent Form
- Inclusion Criteria Healthy Controls:
- Informed consent
- Male or female healthy controls 18-80 years of age
- Able to understand and willing to sign the Informed Consent Form
- Exclusion Criteria Patients:
- Pregnancy or lactation
- Change in disease-specific medication within 8 weeks before enrolment
- Intravenous iron supplementation within the preceding 2 months
- Acute infection
- Comorbidities affecting iron metabolism such as hemolytic anemias, genetic disorders of hemoglobin, diabetes, systemic cardiovascular disease, sickle cell disease, thalassemia
- Exclusion Criteria Healthy Controls:
- Pregnancy or lactation
- Intravenous iron supplementation within the preceding 2 months
- Acute infection
- Heart or lung disease
- Comorbidities affecting iron metabolism such as hemolytic anemias, genetic disorders of hemoglobin, diabetes, systemic cardiovascular disease, sickle cell disease, thalassemia
Exclusion
Key Trial Info
Start Date :
May 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04086537
Start Date
May 2 2019
End Date
February 28 2021
Last Update
April 29 2021
Active Locations (1)
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1
Centre for Pulmonary Hypertension at the Thoraxklinik, Heidelberg University Hospital
Heidelberg, Germany, 69126