Pulmonary Arterial HypertensionAMIANCT04086537
BMPR2 Mutations and Iron Metabolism in Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension, run by Heidelberg University at 1 site in Germany.
Trial 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 Center for Pulmonary Hypertension may be contacted to participate in the study. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- hepcidin levels and BMPR2 expression
- How many people
- 109 participants
- Where
- 1 siteGermany
- Study dates
- 2 May 2019to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: BMPR2-mutation carriers and non-BMPR2 mutation carriers will be asked for participation in the study. Healthy controls will be invited to participate in this study to obtain comparable levels of hepcidin and BMPR2 pathway members. This control group will be age and gender matched to non-BMPR2 mutation carriers. They will not receive any further examinations. BMPR2 mutation status will not be investigated.
Who may be able to join
- 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
- Informed consent
- Male or female healthy controls 18-80 years of age
- Able to understand and willing to sign the Informed Consent Form
Who cannot join
- 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
- Pregnancy or lactation
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centre for Pulmonary Hypertension at the Thoraxklinik, Heidelberg University Hospital
Heidelberg, 69126
About this study
Official title: Association Between BMPR2 Mutations and Iron Metabolism in Pulmonary Arterial Hypertension Patients: an Explorative Cross-sectional Study
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 Center for Pulmonary Hypertension may be contacted to participate in the study. Clinical and laboratory values will be collected prospectively.
Patients with IPAH/HPAH and other forms of PAH who are newly diagnosed within the duration of the trial will receive routine diagnostic workup including the routine information about a possible BMPR2 mutation analysis for IPAH/HPAH patients according to guidelines.
Read more
During their routine visit the patients' medical history will be obtained and physical examination will be conducted. Moreover, an electrocardiogram (ECG), determination of World Health Organization (WHO)-functional class, laboratory testing (NT-proBNP and routine laboratory), echocardiography will be routinely carried out. BMPR2 expression levels will be measured in blood samples. Additionally, laboratory samples will be collected for analysis of further parameters reflecting iron metabolism such as hepcidin, ferritin, iron levels, IL6 and circulating soluble transferrin receptor Levels.
In addition, healthy controls will be invited to participate in this study to obtain comparable levels of hepcidin and BMPR2 pathway members.
Read the 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 decompensation. It crucially affects exercise capacity, quality of life and prognosis. Idiopathic and heritable forms of PAH (IPAH and HPAH) are often associated with mutations of the bone morphogenetic protein receptor 2 (BMPR2) accompanied by disease development at an earlier age, more severe hemodynamic phenotype and a higher mortality rate. Other forms of PAH also show reduced expression levels of BMPR2, even if no BMPR2 mutation has been identified in these patients. Moreover, the balance of iron metabolism was shown to be disturbed in IPAH patients. IPAH patients suffered from iron deficiency with low levels of serum iron concentrations and while at the same time displaying high levels of the iron uptake regulating hormon hepcidin. The hormone hepcidin, which inhibits iron absorption from the intestine, is upregulated by the BMPR2 signaling pathway (via BMP6). The impact of BMPR2 expression on iron homeostasis, however, has not been investigated yet.
Mutation and non-mutation carriers with invasively diagnosed PAH by right heart catheter and under optimized medical therapy will be enrolled in this study. An explicit exclusion criterion is intravenous iron supplementation in the last 2 months to capture their natural iron metabolic status. Subjects will be recruited at the Center for Pulmonary Hypertension at Thoraxklinik Heidelberg University Hospital. The measurement of BMPR2 expression will be performed with real-time polymerase chain reaction. In addition, routine laboratory parameters of iron metabolism and clinical parameters will be statistically correlated with the BMPR2 expression of BMPR2 mutation carriers and non-mutation carriers. Clinical examinations will comprise of routine diagnostic workup. No study specific clinical assessments will be performed. For diagnostic workup, an extended blood analysis for BMPR2 expression will be performed, which is mentioned in the informed consent document.
In addition, healthy controls will be invited to participate in this study.Healthy controls will only receive a blood collection to obtain control values for hepcidin, BMPR2 expression rate and levels of BMPR2 pathway members such as Bone Morphogenetic Protein 2 and 6 (BMP2 and BMP6). They will not receive any further examinations. BMPR2 mutation status will not be investigated. The control group will be age and gender matched to non-BMPR2 mutation carriers.
Therefore, this study aims to investigate whether PAH patients with a reduced expression rate of BMPR2 have altered serum levels of hepcidin and further iron related metabolites compared to PAH patients with normal expression levels and whether these patients present with more pronounced limitations in clinical parameters. This study could help to understand iron metabolism in PAH and generate new therapeutic targets for the treatment of the disease.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- hepcidin levels and BMPR2 expression
- Keywords
- Pulmonary Arterial Hypertension, BMPR2, Iron Metabolism, Hepcidin, Mutations
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepcidin levels and BMPR2 expressionDiagnostic test
Samples will be collected in the three groups. Hepcidin levels will be measured in serum using ELISA and BMPR2 expression will be assessed as previously described using real time-qPCR
| Study group | Role | What they receive |
|---|---|---|
| BMPR2-mutation carriers | Patients affected by pulmonary arterial hypertension (PAH) with already determined BMPR2 mutation status (hereditary PAH, HPAH) or patients with idiopathic PAH (IPAH) and other forms of PAH who are newly diagnosed within the duration of the study and resulted positive for mutation at the routinely-performed (according to current guidelines) BMPR2 analysis. Receives: Diagnostic Test: hepcidin levels and BMPR2 expression | |
| non-BMPR2 mutation carriers | Patients affected by Pulmonary arterial hypertension (PAH) who resulted negative at the routinely-performed (according to current guidelines) BMPR2 analysis (Idiopathic PAH, IPAH) or patients with Idiopathic PAH (IPAH) and other forms of PAH who are newly diagnosed within the duration of the study and resulted negative for mutation at the routinely-performed (according to current guidelines) BMPR2 analysis. Receives: Diagnostic Test: hepcidin levels and BMPR2 expression | |
| healthy controls | Healthy controls free of heart and lung disease or any comorbidities affecting iron metabolism. This control group will be age and gender matched to non-BMPR2 mutation carriers. Receives: Diagnostic Test: hepcidin levels and BMPR2 expression |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between absolute values of hepcidin levels and BMPR2 expression
assessed as correlation between BMPR2 expression levels and hepcidin levels
Measured: at enrollment
The relationship between hepcidin levels and BMPR2 expression
analysis of differences of hepcidin levels in BMPR2 mutation carriers and non-carriers (BMPR2 mutation carriers are assumed to have a lower expression level of BMPR2)
Measured: at enrollment
Secondary outcomes (45)
Correlation of BMPR2 expression levels with ferritin levels
Ferritin levels
Measured: at enrollment
Correlation of BMPR2 expression levels with transferrin levels
Transferrin levels
Measured: at enrollment
Correlation of BMPR2 expression levels with soluble transferrin receptor saturation and concentration
Soluble transferrin receptor saturation and concentration
Measured: at enrollment
Correlation of BMPR2 expression levels with iron levels
Iron levels
Measured: at enrollment
Correlation of BMPR2 expression levels with red blood distribution cell width
Red blood distribution cell width
Measured: at enrollment
Correlation of BMPR2 expression levels with erythroferrone levels
Erythroferrone levels
Measured: at enrollment
Correlation of BMPR2 expression levels with hemoglobin levels
Hemoglobin levels
Measured: at enrollment
Correlation of BMPR2 expression levels with hematocrit
Hematocrit
Measured: at enrollment
Correlation of BMPR2 expression levels with erythropoietin (EPO) levels
Erythropoietin (EPO) levels
Measured: at enrollment
Correlation of BMPR2 expression levels with C-reactive protein levels
C-reactive protein levels
Measured: at enrollment
Correlation of BMPR2 expression levels with interleukin 6 (IL6) levels
Interleukin 6 (IL6) levels to approximate inflammation
Measured: at enrollment
Correlation of BMPR2 expression levels with NT-proBNP levels
NT-proBNP levels
Measured: at enrollment
Correlation of BMPR2 expression levels with BMP2 messenger ribonucleid acid (mRNA) expression levels
BMP2 mRNA expression levels
Measured: at enrollment
Correlation of BMPR2 expression levels with BMP6 messenger ribonucleid acid (mRNA) expression levels
BMP6 mRNA expression levels
Measured: at enrollment
Correlation of BMPR2 expression levels with overall transcriptomic analysis in blood samples and formalin fixed human PAH lung tissue samples
overall transcriptomic analysis in blood samples and formalin fixed human PAH lung tissue samples
Measured: at enrollment
Correlation of BMPR2 expression levels with BMPR2 protein levels
BMPR2 protein levels
Measured: at enrollment
Correlation of BMPR2 expression levels with BMP2 protein levels
BMP2 protein levels
Measured: at enrollment
Correlation of BMPR2 expression levels with BMP6 protein levels
BMP6 protein levels
Measured: at enrollment
Correlation of BMPR2 expression levels with 6-minute walking distance (6-MWD)
6-minute walking distance (6-MWD)
Measured: at enrollment
Correlation of BMPR2 expression levels with BORG Scale of 6-minute walking distance (6-MWD)
Borg Scale of 6-minute walking distance (6-MWD)
Measured: at enrollment
Correlation of BMPR2 expression levels with WHO functional class
WHO functional class
Measured: at enrollment
Correlation of BMPR2 expression levels with forced vital capacity (FVC)
forced vital capacity (FVC)
Measured: at enrollment
Correlation of BMPR2 expression levels with forced expiratory volume in one second (FEV1)
forced expiratory volume in one second (FEV1)
Measured: at enrollment
Correlation of BMPR2 expression levels with forced expiratory flow (FEV)
forced expiratory flow (FEV)
Measured: at enrollment
Correlation of BMPR2 expression levels with total lung capacity (TLC)
total lung capacity (TLC)
Measured: at enrollment
Correlation of BMPR2 expression levels with diffusion-limited carbon monoxide (DLCo)
diffusion-limited carbon monoxide (DLCo)
Measured: at enrollment
Correlation of BMPR2 expression levels with residual volume
residual volume, normally accounting for about 25% of total lung capacity
Measured: at enrollment
Correlation of BMPR2 expression levels with blood gas analysis including partial pressure of oxygen
partial pressure of oxygen
Measured: at enrollment
Correlation of BMPR2 expression levels with blood gas analysis including partial pressure of carbon dioxide
partial pressure of carbon dioxide
Measured: at enrollment
Correlation of BMPR2 expression levels with blood gas analysis including oxygen saturation
oxygen saturation
Measured: at enrollment
Correlation of BMPR2 expression levels with blood gas analysis including supplemental oxygen "yes" or "no"
supplemental oxygen "yes" or "no"
Measured: at enrollment
Correlation of BMPR2 expression levels with cardiac output (CO)
cardiac output (CO) measured by right heart catheterization
Measured: at enrollment
Correlation of BMPR2 expression levels with cardiac index (CI)
cardiac index (CI) measured by right heart catheterization
Measured: at enrollment
Correlation of BMPR2 expression levels with pulmonary capillary wedge pressure (PAWP)
pulmonary capillary wedge pressure (PAWP) measured by right heart catheterization
Measured: at enrollment
Correlation of BMPR2 expression levels with mixed venous oxygen saturation (SvO2)
mixed venous oxygen saturation (SvO2) measured by right heart catheterization
Measured: at enrollment
Correlation of BMPR2 expression levels with right atrium area (RA-area)
right atrium area (RA-area) determined by echocardiography
Measured: at enrollment
Correlation of BMPR2 expression levels with right ventricle area (RV-area)
right ventricle area (RV-area) determined by echocardiography
Measured: at enrollment
Correlation of BMPR2 expression levels with myocardial performance index (Tei)
myocardial performance index (Tei) determined by echocardiography
Measured: at enrollment
Correlation of BMPR2 expression levels with tricuspid annular plane systolic excursion (TAPSE)
tricuspid annular plane systolic excursion (TAPSE) determined by echocardiography
Measured: at enrollment
Correlation of BMPR2 Expression with systolic pulmonary artery pressure
systolic pulmonary artery pressure determined by echocardiography
Measured: at enrollment
Correlation of BMPR2 Expression with right ventricular function
right ventricular function determined by echocardiography
Measured: at enrollment
Correlation of BMPR2 Expression with left ventricular function
left ventricular function determined by echocardiography
Measured: at enrollment
Correlation of BMPR2 Expression with right ventricular pressure
systolic, diastolic and mean right ventricular pressure measured by right heart catheterization
Measured: at enrollment
Correlation of BMPR2 Expression with pulmonary artery pressure
systolic, diastolic and mean pulmonary artery pressure measured by right heart catheterization
Measured: at enrollment
Correlation of BMPR2 Expression with pulmonary vascular resistance
pulmonary vascular resistance measured by right heart catheterization
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start2 May 2019
- Primary completion31 Jan 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Heidelberg, Hannover Medical School, University Hospital Carl Gustav Carus, University of Leipzig, University of Giessen
- Responsible party
- Principal investigator, Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086537
- Sponsor's protocol ID
- 2019-03IM
- Acronym
- AMIA
- Status last verified
- Apr 2021
- First submitted
- 9 Sep 2019
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between BMPR2 Mutations and Iron Metabolism in Pulmonary Arterial Hypertension Patients: an Explorative Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04086537
- Acronym / sponsor ID
- AMIA / 2019-03IM
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Pulmonary Arterial Hypertension, BMPR2, Iron Metabolism, Hepcidin, Mutations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- University Hospital Heidelberg, Hannover Medical School, University Hospital Carl Gustav Carus, University of Leipzig, University of Giessen
- Study start
- 2 May 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Center for Pulmonary Hypertension may be contacted to participate in the study. Clinical and laboratory values will be collected prospectively.
Patients with IPAH/HPAH and other forms of PAH who are newly diagnosed within the duration of the trial will receive routine diagnostic workup including the routine information about a possible BMPR2 mutation analysis for IPAH/HPAH patients according to guidelines.
During their routine visit the patients' medical history will be obtained and physical examination will be conducted. Moreover, an electrocardiogram (ECG), determination of World Health Organization (WHO)-functional class, laboratory testing (NT-proBNP and routine laboratory), echocardiography will be routinely carried out. BMPR2 expression levels will be measured in blood samples. Additionally, laboratory samples will be collected for analysis of further parameters reflecting iron metabolism such as hepcidin, ferritin, iron levels, IL6 and circulating soluble transferrin receptor Levels.
In addition, healthy controls will be invited to participate in this study to obtain comparable levels of hepcidin and BMPR2 pathway members.
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 decompensation. It crucially affects exercise capacity, quality of life and prognosis. Idiopathic and heritable forms of PAH (IPAH and HPAH) are often associated with mutations of the bone morphogenetic protein receptor 2 (BMPR2) accompanied by disease development at an earlier age, more severe hemodynamic phenotype and a higher mortality rate. Other forms of PAH also show reduced expression levels of BMPR2, even if no BMPR2 mutation has been identified in these patients. Moreover, the balance of iron metabolism was shown to be disturbed in IPAH patients. IPAH patients suffered from iron deficiency with low levels of serum iron concentrations and while at the same time displaying high levels of the iron uptake regulating hormon hepcidin. The hormone hepcidin, which inhibits iron absorption from the intestine, is upregulated by the BMPR2 signaling pathway (via BMP6). The impact of BMPR2 expression on iron homeostasis, however, has not been investigated yet.
Mutation and non-mutation carriers with invasively diagnosed PAH by right heart catheter and under optimized medical therapy will be enrolled in this study. An explicit exclusion criterion is intravenous iron supplementation in the last 2 months to capture their natural iron metabolic status. Subjects will be recruited at the Center for Pulmonary Hypertension at Thoraxklinik Heidelberg University Hospital. The measurement of BMPR2 expression will be performed with real-time polymerase chain reaction. In addition, routine laboratory parameters of iron metabolism and clinical parameters will be statistically correlated with the BMPR2 expression of BMPR2 mutation carriers and non-mutation carriers. Clinical examinations will comprise of routine diagnostic workup. No study specific clinical assessments will be performed. For diagnostic workup, an extended blood analysis for BMPR2 expression will be performed, which is mentioned in the informed consent document.
In addition, healthy controls will be invited to participate in this study.Healthy controls will only receive a blood collection to obtain control values for hepcidin, BMPR2 expression rate and levels of BMPR2 pathway members such as Bone Morphogenetic Protein 2 and 6 (BMP2 and BMP6). They will not receive any further examinations. BMPR2 mutation status will not be investigated. The control group will be age and gender matched to non-BMPR2 mutation carriers.
Therefore, this study aims to investigate whether PAH patients with a reduced expression rate of BMPR2 have altered serum levels of hepcidin and further iron related metabolites compared to PAH patients with normal expression levels and whether these patients present with more pronounced limitations in clinical parameters. This study could help to understand iron metabolism in PAH and generate new therapeutic targets for the treatment of the disease.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMPR2-mutation carriers | – | Diagnostic Test: hepcidin levels and BMPR2 expressionPatients affected by pulmonary arterial hypertension (PAH) with already determined BMPR2 mutation status (hereditary PAH, HPAH) or patients with idiopathic PAH (IPAH) and other forms of PAH who are newly diagnosed within the duration of the study and resulted positive for mutation at the routinely-performed (according to current guidelines) BMPR2 analysis. |
| non-BMPR2 mutation carriers | – | Diagnostic Test: hepcidin levels and BMPR2 expressionPatients affected by Pulmonary arterial hypertension (PAH) who resulted negative at the routinely-performed (according to current guidelines) BMPR2 analysis (Idiopathic PAH, IPAH) or patients with Idiopathic PAH (IPAH) and other forms of PAH who are newly diagnosed within the duration of the study and resulted negative for mutation at the routinely-performed (according to current guidelines) BMPR2 analysis. |
| healthy controls | – | Diagnostic Test: hepcidin levels and BMPR2 expressionHealthy controls free of heart and lung disease or any comorbidities affecting iron metabolism. This control group will be age and gender matched to non-BMPR2 mutation carriers. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- BMPR2-mutation carriers and non-BMPR2 mutation carriers will be asked for participation in the study. Healthy controls will be invited to participate in this study to obtain comparable levels of hepcidin and BMPR2 pathway members. This control group will be age and gender matched to non-BMPR2 mutation carriers. They will not receive any further examinations. BMPR2 mutation status will not be investigated.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hepcidin levels and BMPR2 expressionSamples will be collected in the three groups. Hepcidin levels will be measured in serum using ELISA and BMPR2 expression will be assessed as previously described using real time-qPCR | Diagnostic test | BMPR2-mutation carriers, healthy controls, non-BMPR2 mutation carriers |
Primary outcome
The relationship between absolute values of hepcidin levels and BMPR2 expression
Time frame: at enrollment
assessed as correlation between BMPR2 expression levels and hepcidin levels
The relationship between hepcidin levels and BMPR2 expression
Time frame: at enrollment
analysis of differences of hepcidin levels in BMPR2 mutation carriers and non-carriers (BMPR2 mutation carriers are assumed to have a lower expression level of BMPR2)
45 secondary outcomes
Correlation of BMPR2 expression levels with ferritin levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with transferrin levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with soluble transferrin receptor saturation and concentration
Time frame: at enrollment
Correlation of BMPR2 expression levels with iron levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with red blood distribution cell width
Time frame: at enrollment
Correlation of BMPR2 expression levels with erythroferrone levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with hemoglobin levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with hematocrit
Time frame: at enrollment
Correlation of BMPR2 expression levels with erythropoietin (EPO) levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with C-reactive protein levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with interleukin 6 (IL6) levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with NT-proBNP levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with BMP2 messenger ribonucleid acid (mRNA) expression levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with BMP6 messenger ribonucleid acid (mRNA) expression levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with overall transcriptomic analysis in blood samples and formalin fixed human PAH lung tissue samples
Time frame: at enrollment
Correlation of BMPR2 expression levels with BMPR2 protein levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with BMP2 protein levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with BMP6 protein levels
Time frame: at enrollment
Correlation of BMPR2 expression levels with 6-minute walking distance (6-MWD)
Time frame: at enrollment
Correlation of BMPR2 expression levels with BORG Scale of 6-minute walking distance (6-MWD)
Time frame: at enrollment
Correlation of BMPR2 expression levels with WHO functional class
Time frame: at enrollment
Correlation of BMPR2 expression levels with forced vital capacity (FVC)
Time frame: at enrollment
Correlation of BMPR2 expression levels with forced expiratory volume in one second (FEV1)
Time frame: at enrollment
Correlation of BMPR2 expression levels with forced expiratory flow (FEV)
Time frame: at enrollment
Correlation of BMPR2 expression levels with total lung capacity (TLC)
Time frame: at enrollment
Correlation of BMPR2 expression levels with diffusion-limited carbon monoxide (DLCo)
Time frame: at enrollment
Correlation of BMPR2 expression levels with residual volume
Time frame: at enrollment
Correlation of BMPR2 expression levels with blood gas analysis including partial pressure of oxygen
Time frame: at enrollment
Correlation of BMPR2 expression levels with blood gas analysis including partial pressure of carbon dioxide
Time frame: at enrollment
Correlation of BMPR2 expression levels with blood gas analysis including oxygen saturation
Time frame: at enrollment
Correlation of BMPR2 expression levels with blood gas analysis including supplemental oxygen "yes" or "no"
Time frame: at enrollment
Correlation of BMPR2 expression levels with cardiac output (CO)
Time frame: at enrollment
Correlation of BMPR2 expression levels with cardiac index (CI)
Time frame: at enrollment
Correlation of BMPR2 expression levels with pulmonary capillary wedge pressure (PAWP)
Time frame: at enrollment
Correlation of BMPR2 expression levels with mixed venous oxygen saturation (SvO2)
Time frame: at enrollment
Correlation of BMPR2 expression levels with right atrium area (RA-area)
Time frame: at enrollment
Correlation of BMPR2 expression levels with right ventricle area (RV-area)
Time frame: at enrollment
Correlation of BMPR2 expression levels with myocardial performance index (Tei)
Time frame: at enrollment
Correlation of BMPR2 expression levels with tricuspid annular plane systolic excursion (TAPSE)
Time frame: at enrollment
Correlation of BMPR2 Expression with systolic pulmonary artery pressure
Time frame: at enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between absolute values of hepcidin levels and BMPR2 expression (time frame: at enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.