Myeloproliferative NeoplasmNCT06647706
Prevalence and Risk Factors of Pulmonary Hypertension in Patients with Myeloproliferative Neoplasms in Assiut University Hospital.
An observational study of Myeloproliferative Neoplasm, run by Assiut University.
Trial summary
This study will evaluate the MPNs patients for the presence of PH by using a non invasive method ( Transthoracic echocardiography (TTE )) and correlate the clinical and laboratory data of these patients with development of PH aiming to identify risk factors for PH and parameters that can predict PH in MPNs patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- What is being tested?
- Transthoracic echocardiography
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Dec 2025
- How long will I take part?
- 12 Months
- 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: Assiut University Hospitals. (internal medicine Department and Outpatient Hematology Clinic )
Who may be able to join
- Adult patients (≥18 years)
- patients diagnosed with MPNs. including polycythemia vera (PV), essential thrombocythemia (ET), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF)
Who cannot join
- patients less than 18 years old.
- patients with cardiac diseases involving the left side of the heart or congenital heart diseases.
- patients with chronic lung disease and primary pulmonary hypertension.
- patients with chronic kidney disease.
- patients with inherited and acquired chronic hemolytic anemia.
- patients with connective tissue diseases.
- patients with with past or current pulmonary embolism.
Trial locations and contacts
No sites are listed yet.
About this study
This study will evaluate the MPNs patients for the presence of PH by using a non invasive method ( Transthoracic echocardiography (TTE )) and correlate the clinical and laboratory data of these patients with development of PH aiming to identify risk factors for PH and parameters that can predict PH in MPNs patients and thus,identifying MPNs patients 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.
Read the detailed description
Pulmonary hypertension (PH) is a syndrome characterized by marked remodeling of the pulmonary vasculature and a progressive increase in the pulmonary vascular load. PH is a serious complex disorder that associated with high morbidity and mortality rates.
PH is a complication of various hematologic diseases including myeloproliferative neoplasms (MPNs) which are included in group 5 ph.
Myeloproliferative neoplasms (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), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF).
PH is defined as an elevation in the mean pulmonary artery pressure (mPAP) that is greater than or equal to 25 mmHg, which was measured at rest via right heart catheterization (RHC).
Systolic pulmonary artery pressure (sPAP) can be accurately estimated using Doppler transthoracic echocardiography (TTE), recent advances in noninvasive imaging led Doppler TTE to become the most widespread and well-recognized technique for non-invasive sPAP evaluation and the screening modality of choice for evaluating PH.
Active monitoring of PH in patients with MPN may be warranted. Identification of risk factors predicting PH in MPN patients promises early detection and possibly improved PH management and therapy.
- Conditions
- Myeloproliferative Neoplasm
- Being tested
- Transthoracic echocardiography
- Keywords
- pulmonary HTN, MPNs
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic echocardiographyDevice
MPNs patients who have echocardiographic probability of PH
| Study group | Role | What they receive |
|---|---|---|
| MPNs patients who have echocardiographic probability of PH | MPNs patients who have echocardiographic probability of PH Receives: Device: Transthoracic echocardiography | |
| MPNs patients who do not have echocardiographic probability of PH | MPNs patients who do not have echocardiographic probability of PH Receives: Device: Transthoracic echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the prevalence of pulmonary hypertension in patients with MPNs at Assiut University Hospital
To determine the prevalence of pulmonary hypertension in patients with MPNs at Assiut University Hospital by using a non invasive method ( Transthoracic echocardiography (TTE ))
Measured: 1 year
Secondary outcomes (1)
predictors of pulmonary hypertension in MPNs patients
To find the predictors of pulmonary hypertension through analysis of the data of those patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Khalaf Hadyia Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647706
- Sponsor's protocol ID
- Prevalence of PH in MPNs
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023 Jan 6;61(1):2200879. doi: 10.1183/13993003.00879-2022. Print 2023 Jan. No abstract available.
PubMed 36028254Ferrari A, Scandura J, Masciulli A, Krichevsky S, Gavazzi A, Barbui T. Prevalence and risk factors for Pulmonary Hypertension associated with chronic Myeloproliferative Neoplasms. Eur J Haematol. 2021 Feb;106(2):250-259. doi: 10.1111/ejh.13543. Epub 2020 Nov 22.
PubMed 33135220Lafitte S, Pillois X, Reant P, Picard F, Arsac F, Dijos M, Coste P, Dos Santos P, Roudaut R. Estimation of pulmonary pressures and diagnosis of pulmonary hypertension by Doppler echocardiography: a retrospective comparison of routine echocardiography and invasive hemodynamics. J Am Soc Echocardiogr. 2013 May;26(5):457-63. doi: 10.1016/j.echo.2013.02.002. Epub 2013 Mar 16.
PubMed 23510536Galie 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. 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 Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
PubMed 26318161Lahm T, Chakinala MM. World Health Organization group 5 pulmonary hypertension. Clin Chest Med. 2013 Dec;34(4):753-78. doi: 10.1016/j.ccm.2013.08.005. Epub 2013 Oct 18.
PubMed 24267303Simonneau G, Gatzoulis MA, Adatia I, Celermajer D, Denton C, Ghofrani A, Gomez Sanchez MA, Krishna Kumar R, Landzberg M, Machado RF, Olschewski H, Robbins IM, Souza R. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D34-41. doi: 10.1016/j.jacc.2013.10.029.
PubMed 24355639Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.
PubMed 27069254
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Pulmonary Hypertension in Patients with Myeloproliferative Neoplasms in Assiut University Hospital.
- ClinicalTrials.gov ID
- NCT06647706
- Acronym / sponsor ID
- Prevalence of PH in MPNs
- Conditions
- Myeloproliferative Neoplasm
- Keywords
- pulmonary HTN, MPNs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Oct 2024 (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.
This study will evaluate the MPNs patients for the presence of PH by using a non invasive method ( Transthoracic echocardiography (TTE )) and correlate the clinical and laboratory data of these patients with development of PH aiming to identify risk factors for PH and parameters that can predict PH in MPNs patients and thus,identifying MPNs patients 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.
Detailed description
Pulmonary hypertension (PH) is a syndrome characterized by marked remodeling of the pulmonary vasculature and a progressive increase in the pulmonary vascular load. PH is a serious complex disorder that associated with high morbidity and mortality rates.
PH is a complication of various hematologic diseases including myeloproliferative neoplasms (MPNs) which are included in group 5 ph.
Myeloproliferative neoplasms (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), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF).
PH is defined as an elevation in the mean pulmonary artery pressure (mPAP) that is greater than or equal to 25 mmHg, which was measured at rest via right heart catheterization (RHC).
Systolic pulmonary artery pressure (sPAP) can be accurately estimated using Doppler transthoracic echocardiography (TTE), recent advances in noninvasive imaging led Doppler TTE to become the most widespread and well-recognized technique for non-invasive sPAP evaluation and the screening modality of choice for evaluating PH.
Active monitoring of PH in patients with MPN may be warranted. Identification of risk factors predicting PH in MPN patients promises early detection and possibly improved PH management and therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MPNs patients who have echocardiographic probability of PH | – | Device: Transthoracic echocardiographyMPNs patients who have echocardiographic probability of PH |
| MPNs patients who do not have echocardiographic probability of PH | – | Device: Transthoracic echocardiographyMPNs patients who do not have echocardiographic probability of PH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Assiut University Hospitals. (internal medicine Department and Outpatient Hematology Clinic )
Key inclusion criteria (2 listed)
- Adult patients (≥18 years)
- patients diagnosed with MPNs. including polycythemia vera (PV), essential thrombocythemia (ET), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF)
Key exclusion criteria (7 listed)
- patients less than 18 years old.
- patients with cardiac diseases involving the left side of the heart or congenital heart diseases.
- patients with chronic lung disease and primary pulmonary hypertension.
- patients with chronic kidney disease.
- patients with inherited and acquired chronic hemolytic anemia.
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 |
|---|---|---|
| Transthoracic echocardiographyMPNs patients who have echocardiographic probability of PH | Device | MPNs patients who do not have echocardiographic probability of PH, MPNs patients who have echocardiographic probability of PH |
Primary outcome
determine the prevalence of pulmonary hypertension in patients with MPNs at Assiut University Hospital
Time frame: 1 year
To determine the prevalence of pulmonary hypertension in patients with MPNs at Assiut University Hospital by using a non invasive method ( Transthoracic echocardiography (TTE ))
1 secondary outcome
predictors of pulmonary hypertension in MPNs patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 36028254Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023 Jan 6;61(1):2200879. doi: 10.1183/13993003.00879-2022. Print 2023 Jan. No abstract available.
- Background: PubMed 33135220Ferrari A, Scandura J, Masciulli A, Krichevsky S, Gavazzi A, Barbui T. Prevalence and risk factors for Pulmonary Hypertension associated with chronic Myeloproliferative Neoplasms. Eur J Haematol. 2021 Feb;106(2):250-259. doi: 10.1111/ejh.13543. Epub 2020 Nov 22.
- Background: PubMed 23510536Lafitte S, Pillois X, Reant P, Picard F, Arsac F, Dijos M, Coste P, Dos Santos P, Roudaut R. Estimation of pulmonary pressures and diagnosis of pulmonary hypertension by Doppler echocardiography: a retrospective comparison of routine echocardiography and invasive hemodynamics. J Am Soc Echocardiogr. 2013 May;26(5):457-63. doi: 10.1016/j.echo.2013.02.002. Epub 2013 Mar 16.
- Background: PubMed 26318161Galie 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. 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 Respir J. 2015 Oct;46(4):903-75. doi: 10.1183/13993003.01032-2015. Epub 2015 Aug 29.
- Background: PubMed 24267303Lahm T, Chakinala MM. World Health Organization group 5 pulmonary hypertension. Clin Chest Med. 2013 Dec;34(4):753-78. doi: 10.1016/j.ccm.2013.08.005. Epub 2013 Oct 18.
- Background: PubMed 24355639Simonneau G, Gatzoulis MA, Adatia I, Celermajer D, Denton C, Ghofrani A, Gomez Sanchez MA, Krishna Kumar R, Landzberg M, Machado RF, Olschewski H, Robbins IM, Souza R. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013 Dec 24;62(25 Suppl):D34-41. doi: 10.1016/j.jacc.2013.10.029.
- Background: PubMed 27069254Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, Bloomfield CD, Cazzola M, Vardiman JW. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016 May 19;127(20):2391-405. doi: 10.1182/blood-2016-03-643544. Epub 2016 Apr 11.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm, run by Assiut 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 18 Oct 2024. 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 Abdelrhman khalaf mohamed, master (+2001016901852, Eldalyabdo30@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determine the prevalence of pulmonary hypertension in patients with MPNs at Assiut University Hospital (time frame: 1 year). 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 NCT06647706, which also lists 7 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 18 Oct 2024.