Chronic Myeloproliferative DisordersNCT04843475
Study of Pulmonary Hypertension in Patients With Chronic Myeloproliferative Disorders at Sohag University Hospital
An observational study of Chronic Myeloproliferative Disorders, run by Sohag University.
Trial summary
Pulmonary hypertension (PH) is a complex condition that may be related to many clinical conditions. It is a serious disorder with a high morbidity and mortality rates. PH is classified into five groups according to clinical characteristics, pathological findings, hemodynamic characteristics and treatment response… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloproliferative Disorders
- What is being tested?
- Echocardiography
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The outpatient Hematology Clinic at Sohag University Hospital.
Who may be able to join
- Patients over 18 years old.
- Patients diagnosed with polycythemia vera, essential thrombocythemia, primary myelofibrosis and chronic myeloid leukemia according to the 2016 WHO classification and attended the outpatient Hematology Clinic at Sohag University Hospital.
Who cannot join
- Patients less than 18 years old.
- Patients with pre-existing pulmonary hypertension from any other cause.
- Patients with left sided heart disease e.g. left sided heart failure, left sided valvular diseases, cardiomyopathies, left ventricular systolic or diastolic dysfunction.
- Patients with chronic lung disease e.g. COPD \& interstitial lung disease.
- Patients with chronic kidney disease.
- Patients with connective tissue diseases.
- Patients with congenital heart diseases.
Trial locations and contacts
No sites are listed yet.
Ali M Kassem, Professor contact
About this study
Pulmonary hypertension (PH) is a complex condition that may be related to many clinical conditions. It is a serious disorder with a high morbidity and mortality rates. PH is classified into five groups according to clinical characteristics, pathological findings, hemodynamic characteristics and treatment response (Galie N, et al., 2016). These five groups include pulmonary arterial hypertension, PH due to left sided heart disease, PH due to lung disease and/or hypoxia, chronic thromboembolic pulmonary hypertension, or other pulmonary arterial obstruction and PH with unclear and/or multifactorial mechanisms (Simonneau G, et al., 2013).
PH is a major complication of several hematologic disorders including myeloproliferative neoplasms (MPNs). MPNs are a group of diseases characterized by uncontrolled proliferation of at least one myeloid series due to an abnormal hematopoietic cell clone. There are different types of MPNs including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) \& chronic myeloid leukemia ( CML). Myeloproliferative neoplasms (MPNs) are included in group 5 PH (Arber DA, et al., 2016).
This study will analyze the clinical and laboratory data of MPNs patients and correlate them with development of PH in these patients aiming to identify parameters that can predict PH in MPNs patients and thus, identifying MPNs patients at highest risk for PH who require close monitoring \& screening for PH hoping that early detection and management of PH in MPNs patients can improve morbidity, prognosis and survival in those patients
- Conditions
- Chronic Myeloproliferative Disorders
- Being tested
- Echocardiography
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Trans-thoracic Echocardiography
| Study group | Role | What they receive |
|---|---|---|
| MPNs patients who have echocardiographic probability of PH. | Not described Receives: Diagnostic Test: Echocardiography | |
| MPNs patients who do not have echocardiographic probability of PH | Not described Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients
Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients
Measured: 2 years
Secondary outcomes (1)
Identification of independent different predictors of pulmonary hypertension in chronic myeloproliferative disorders patients
Identification of independent different predictors of pulmonary hypertension in chronic myeloproliferative disorders patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hamdy Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843475
- Sponsor's protocol ID
- Soh-Med-21-04-15
- Status last verified
- Apr 2021
- First submitted
- 12 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
PubMed 26320113Yaylali YT, Yilmaz S, Akgun-Cagliyan G, Kilic O, Kaya E, Senol H, Ozen F. Association of Disease Subtype and Duration with Echocardiographic Evidence of Pulmonary Hypertension in Myeloproliferative Neoplasm. Med Princ Pract. 2020;29(5):486-491. doi: 10.1159/000506596. Epub 2020 Feb 19.
PubMed 32069470Lopez-Mattei J, Verstovsek S, Fellman B, Iliescu C, Bhatti K, Hassan SA, Kim P, Gray BA, Palaskas NL, Grosu HB, Mamas MA, Faiz SA. Prevalence of pulmonary hypertension in myelofibrosis. Ann Hematol. 2020 Apr;99(4):781-789. doi: 10.1007/s00277-020-03962-2. Epub 2020 Feb 19.
PubMed 32076825
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Pulmonary Hypertension in Patients With Chronic Myeloproliferative Disorders at Sohag University Hospital
- ClinicalTrials.gov ID
- NCT04843475
- Acronym / sponsor ID
- Soh-Med-21-04-15
- Conditions
- Chronic Myeloproliferative Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 13 Apr 2021 (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.
Pulmonary hypertension (PH) is a complex condition that may be related to many clinical conditions. It is a serious disorder with a high morbidity and mortality rates. PH is classified into five groups according to clinical characteristics, pathological findings, hemodynamic characteristics and treatment response (Galie N, et al., 2016). These five groups include pulmonary arterial hypertension, PH due to left sided heart disease, PH due to lung disease and/or hypoxia, chronic thromboembolic pulmonary hypertension, or other pulmonary arterial obstruction and PH with unclear and/or multifactorial mechanisms (Simonneau G, et al., 2013).
PH is a major complication of several hematologic disorders including myeloproliferative neoplasms (MPNs). MPNs are a group of diseases characterized by uncontrolled proliferation of at least one myeloid series due to an abnormal hematopoietic cell clone. There are different types of MPNs including polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF) \& chronic myeloid leukemia ( CML). Myeloproliferative neoplasms (MPNs) are included in group 5 PH (Arber DA, et al., 2016).
This study will analyze the clinical and laboratory data of MPNs patients and correlate them with development of PH in these patients aiming to identify parameters that can predict PH in MPNs patients and thus, identifying MPNs patients at highest risk for PH who require close monitoring \& screening for PH hoping that early detection and management of PH in MPNs patients can improve morbidity, prognosis and survival in those patients
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPNs patients who have echocardiographic probability of PH. | – | Diagnostic Test: Echocardiography |
| MPNs patients who do not have echocardiographic probability of PH | – | Diagnostic Test: Echocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The outpatient Hematology Clinic at Sohag University Hospital.
Key inclusion criteria (2 listed)
- Patients over 18 years old.
- Patients diagnosed with polycythemia vera, essential thrombocythemia, primary myelofibrosis and chronic myeloid leukemia according to the 2016 WHO classification and attended the outpatient Hematology Clinic at Sohag University Hospital.
Key exclusion criteria (7 listed)
- Patients less than 18 years old.
- Patients with pre-existing pulmonary hypertension from any other cause.
- Patients with left sided heart disease e.g. left sided heart failure, left sided valvular diseases, cardiomyopathies, left ventricular systolic or diastolic dysfunction.
- Patients with chronic lung disease e.g. COPD \& interstitial lung disease.
- Patients with chronic kidney disease.
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 |
|---|---|---|
| EchocardiographyTrans-thoracic Echocardiography | Diagnostic test | MPNs patients who do not have echocardiographic probability of PH, MPNs patients who have echocardiographic probability of PH. |
Primary outcome
Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients
Time frame: 2 years
Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients
1 secondary outcome
Identification of independent different predictors of pulmonary hypertension in chronic myeloproliferative disorders patients
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Background: PubMed 26320113Galie N, Humbert M, Vachiery JL, Gibbs S, Lang I, Torbicki A, Simonneau G, Peacock A, Vonk Noordegraaf A, Beghetti M, Ghofrani A, Gomez Sanchez MA, Hansmann G, Klepetko W, Lancellotti P, Matucci M, McDonagh T, Pierard LA, Trindade PT, Zompatori M, Hoeper M; ESC Scientific Document Group. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension: The Joint Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS): Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC), International Society for Heart and Lung Transplantation (ISHLT). Eur Heart J. 2016 Jan 1;37(1):67-119. doi: 10.1093/eurheartj/ehv317. Epub 2015 Aug 29. No abstract available.
- Background: PubMed 32069470Yaylali YT, Yilmaz S, Akgun-Cagliyan G, Kilic O, Kaya E, Senol H, Ozen F. Association of Disease Subtype and Duration with Echocardiographic Evidence of Pulmonary Hypertension in Myeloproliferative Neoplasm. Med Princ Pract. 2020;29(5):486-491. doi: 10.1159/000506596. Epub 2020 Feb 19.
- Background: PubMed 32076825Lopez-Mattei J, Verstovsek S, Fellman B, Iliescu C, Bhatti K, Hassan SA, Kim P, Gray BA, Palaskas NL, Grosu HB, Mamas MA, Faiz SA. Prevalence of pulmonary hypertension in myelofibrosis. Ann Hematol. 2020 Apr;99(4):781-789. doi: 10.1007/s00277-020-03962-2. Epub 2020 Feb 19.
- Individual participant dataSharing planned: Undecided
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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.
Ali M Kassem, Professor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloproliferative Disorders, run by Sohag University.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud H Ahmed, Master (01003707775, mahmoudhamdy@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04843475, which also lists 3 linked publications.
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 15 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.