Philadelphia Negative Myeloproliferative NeoplasmsNCT06615414
Cardiovascular Manifestations in Ph-negative MPN
An observational study of Philadelphia Negative Myeloproliferative Neoplasms, run by Assiut University.
Trial summary
The primary aim of this research is to investigate the clinical and subclinical cardiovascular complications and its relationship with myeloproliferative neoplasms seeking to assess incidence, prevalence and severity in comparison to healthy group and analyze potential risk factors including genetic mutations… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Philadelphia Negative Myeloproliferative Neoplasms
- What is being tested?
- participants are not assigned an intervention as part of the study
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adults aged 18-75 years Participants with MPN will be recruited from clinical Haematology Unit of the Internal Medicine at Assiut university while healthy participants will be recruited from health care workers Inclusion criteria of MPN patients will include individuals diagnosed with myeloproliferative neoplasms: essential thrombocythemia, Polycythemia vera and Primary myelofibrosis Exclusion criteria of MPN patients will encompass individuals with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) , patients who have experienced a myocardial infarction, stroke, heart failure, Hypertension, or significant cardiovascular event before diagnosis of MPN, Patients with severe comorbid conditions that could confound results, such as: Severe renal or hepatic impairment and Active malignancies other than MPN and pregnant and lactating women Study will take place in Assiut university hospitals
Who may be able to join
- patients with confirmed diagnosis of myeloproliferative neoplasms of one of the following:
- Essential thrombocythemia (ET)
- Polycythemia vera (PV)
- Primary myelofibrosis (PMF)
- Adults aged 18 years and older.
- who accept to participate in the study in Assiut university hospital.
Who cannot join
- Patients with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) will be excluded.
- Patients who have experienced a myocardial infarction, stroke, heart failure, Hypertension, or significant cardiovascular event before diagnosis of MPN
- Patients with severe comorbid conditions that could confound results, such as:
- Severe renal or hepatic impairment
- Active malignancies other than MPN
- Pregnant or lactating women should be excluded due to potential risks associated with cardiovascular evaluations.
- at age group below 18 years old.
- who refused to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Subclinical Cardiovascular Manifestations in Philadelphia Negative Myeloproliferative Neoplasms
The primary aim of this research is to investigate the clinical and subclinical cardiovascular complications and its relationship with myeloproliferative neoplasms seeking to assess incidence, prevalence and severity in comparison to healthy group and analyze potential risk factors including genetic mutations, inflammatory markers and hematological parameters
Read the detailed description
Myeloproliferative neoplasms (MPNs) are a group of hematological disorders characterized by clonal proliferation of stem cells leading to excessive production of blood cells. The primary types include polycythemia vera, essential thrombocythemia, and primary myelofibrosis. They share a common characteristic in that they lack the Philadelphia chromosome.
Patients with MPN face an elevated risk of various clinical cardiovascular complications including arterial and venous thromboembolism, hypertension and heart failure. This increased risk can be attributed to several factors including, chronic inflammation, hyperviscosity due to increased blood cells count and genetic mutation like JAK2 V617F which plays a pivotal role in disease pathogenesis.
While clinical cardiovascular events in MPN patients are well-documented, subclinical manifestations such as subclinical atherosclerosis, pulmonary hypertension, left ventriclar hypertrophy, diastolic dysfunction and arrhythmia are often overlooked. These subclinical changes may significantly contribute to morbidity and mortality but are not routinely assessed in clinical practice. Non invasive modalities such as electrocardiography, echocardiography, carotid doppler ultrasound and limb doppler ultrasound can provide vulnerable tools for early detection of these cardiovascular manifestations.
So understanding the relationship between myloproliferative neoplasms and incidence and severity of cardiovascular complications is crucial. This knowledge can enhance risk assessment, improve patient care and outcomes and facilitate targeted interventions.
- Being tested
- participants are not assigned an intervention as part of the study
- Keywords
- Cardiovascular manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
participants are not assigned an intervention as part of the studyOther
Also called participants are not assigned an intervention as part of the study.
participants are not assigned an intervention as part of the study
| Study group | Role | What they receive |
|---|---|---|
| 40 MPN patients | Inclusion criteria:
* patients with confirmed diagnosis of myeloproliferative neoplasms of one of the following:
* Essential thrombocythemia (ET)
* Polycythemia vera (PV)
* Primary myelofibrosis (PMF)
* Adults aged 18 years and older.
* who accept to participate in the study in Assiut university hospital.
Exclusion criteria:
* Patients with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) will be excluded.
* Patients who have experienced a myocardial infarction, stroke, heart failure, Hypertension, or significant cardiovascular event before diagnosis of MPN
* Patients with severe comorbid conditions that could confound results, such as:
* Severe renal or hepatic impairment
* Active malignancies other than MPN
* Pregnant or lactating women should be excluded due to potential risks associated with cardiovascular evaluations.
* at age group below 18 years old.
* who refused to participate in the study. Receives: Other: participants are not assigned an intervention as part of the study | |
| 40 healthy patients | An external control group will consist of age- and gender-matched individuals without any hematological disorders or significant cardiovascular conditions. They will be recruited from health care workers Receives: Other: participants are not assigned an intervention as part of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Cardiovascular Disease and cardiovascular Risk Factors
Assessment of clinical cardiovascular disease (CVD) through patient history, physical examination, and diagnostic tests (e.g., ECG, echocardiography) and Measurement of risk factors such as:
- Blood pressure (systolic and diastolic)
- Lipid profile (total cholesterol, LDL, HDL, triglycerides)
- Body mass index (BMI) kg/m^2
Measured: through study completion, an average of 4 years
Secondary outcomes (1)
Subclinical Cardiovascular Manifestations and Comparison with the healthy control group
Subclinical cardiovascular manifestations will be detected by using of imaging techniques such as:
- Carotid artery doppler ultrasound
- limb doppler ultrasound
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2029 (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 Philadelphia Negative Myeloproliferative NeoplasmsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viola Waheed Saad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615414
- Sponsor's protocol ID
- CVD in MPN
- Status last verified
- Sep 2024
- First submitted
- 15 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guglielmelli P, Gangat N, Coltro G, Lasho TL, Loscocco GG, Finke CM, Morsia E, Sordi B, Szuber N, Hanson CA, Pardanani A, Vannucchi AM, Tefferi A. Mutations and thrombosis in essential thrombocythemia. Blood Cancer J. 2021 Apr 27;11(4):77. doi: 10.1038/s41408-021-00470-y. No abstract available.
PubMed 33907189Leiva O, Bekendam RH, Garcia BD, Thompson C, Cantor A, Chitalia V, Ravid K. Emerging Factors Implicated in Fibrotic Organ-Associated Thrombosis: The Case of Two Organs. TH Open. 2019 Jun 7;3(2):e165-e170. doi: 10.1055/s-0039-1692204. eCollection 2019 Apr.
PubMed 31259299Hultcrantz M, Wilkes SR, Kristinsson SY, Andersson TM, Derolf AR, Eloranta S, Samuelsson J, Landgren O, Dickman PW, Lambert PC, Bjorkholm M. Risk and Cause of Death in Patients Diagnosed With Myeloproliferative Neoplasms in Sweden Between 1973 and 2005: A Population-Based Study. J Clin Oncol. 2015 Jul 10;33(20):2288-95. doi: 10.1200/JCO.2014.57.6652. Epub 2015 Jun 1.
PubMed 26033810Tefferi A, Guglielmelli P, Larson DR, Finke C, Wassie EA, Pieri L, Gangat N, Fjerza R, Belachew AA, Lasho TL, Ketterling RP, Hanson CA, Rambaldi A, Finazzi G, Thiele J, Barbui T, Pardanani A, Vannucchi AM. Long-term survival and blast transformation in molecularly annotated essential thrombocythemia, polycythemia vera, and myelofibrosis. Blood. 2014 Oct 16;124(16):2507-13; quiz 2615. doi: 10.1182/blood-2014-05-579136. Epub 2014 Jul 18.
PubMed 25037629Fidler TP, Xue C, Yalcinkaya M, Hardaway B, Abramowicz S, Xiao T, Liu W, Thomas DG, Hajebrahimi MA, Pircher J, Silvestre-Roig C, Kotini AG, Luchsinger LL, Wei Y, Westerterp M, Snoeck HW, Papapetrou EP, Schulz C, Massberg S, Soehnlein O, Ebert B, Levine RL, Reilly MP, Libby P, Wang N, Tall AR. The AIM2 inflammasome exacerbates atherosclerosis in clonal haematopoiesis. Nature. 2021 Apr;592(7853):296-301. doi: 10.1038/s41586-021-03341-5. Epub 2021 Mar 17.
PubMed 33731931Garypidou V, Vakalopoulou S, Dimitriadis D, Tziomalos K, Sfikas G, Perifanis V. Incidence of pulmonary hypertension in patients with chronic myeloproliferative disorders. Haematologica. 2004 Feb;89(2):245-6. No abstract available.
PubMed 15003906Briukhovetska D, Dorr J, Endres S, Libby P, Dinarello CA, Kobold S. Interleukins in cancer: from biology to therapy. Nat Rev Cancer. 2021 Aug;21(8):481-499. doi: 10.1038/s41568-021-00363-z. Epub 2021 Jun 3.
PubMed 34083781
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Subclinical Cardiovascular Manifestations in Philadelphia Negative Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT06615414
- Acronym / sponsor ID
- CVD in MPN
- Keywords
- Cardiovascular manifestations
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 26 Sep 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.
The primary aim of this research is to investigate the clinical and subclinical cardiovascular complications and its relationship with myeloproliferative neoplasms seeking to assess incidence, prevalence and severity in comparison to healthy group and analyze potential risk factors including genetic mutations, inflammatory markers and hematological parameters
Detailed description
Myeloproliferative neoplasms (MPNs) are a group of hematological disorders characterized by clonal proliferation of stem cells leading to excessive production of blood cells. The primary types include polycythemia vera, essential thrombocythemia, and primary myelofibrosis. They share a common characteristic in that they lack the Philadelphia chromosome.
Patients with MPN face an elevated risk of various clinical cardiovascular complications including arterial and venous thromboembolism, hypertension and heart failure. This increased risk can be attributed to several factors including, chronic inflammation, hyperviscosity due to increased blood cells count and genetic mutation like JAK2 V617F which plays a pivotal role in disease pathogenesis.
While clinical cardiovascular events in MPN patients are well-documented, subclinical manifestations such as subclinical atherosclerosis, pulmonary hypertension, left ventriclar hypertrophy, diastolic dysfunction and arrhythmia are often overlooked. These subclinical changes may significantly contribute to morbidity and mortality but are not routinely assessed in clinical practice. Non invasive modalities such as electrocardiography, echocardiography, carotid doppler ultrasound and limb doppler ultrasound can provide vulnerable tools for early detection of these cardiovascular manifestations.
So understanding the relationship between myloproliferative neoplasms and incidence and severity of cardiovascular complications is crucial. This knowledge can enhance risk assessment, improve patient care and outcomes and facilitate targeted interventions.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40 MPN patients | – | Other: participants are not assigned an intervention as part of the studyInclusion criteria: * patients with confirmed diagnosis of myeloproliferative neoplasms of one of the following: * Essential thrombocythemia (ET) * Polycythemia vera (PV) * Primary myelofibrosis (PMF) * Adults aged 18 years and older. * who accept to participate in the study in Assiut university hospital. Exclusion criteria: * Patients with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) will be excluded. * Patients who have experienced a myocardial infarction, stroke, heart failure, Hypertension, or significant cardiovascular event before diagnosis of MPN * Patients with severe comorbid conditions that could confound results, such as: * Severe renal or hepatic impairment * Active malignancies other than MPN * Pregnant or lactating women should be excluded due to potential risks associated with cardiovascular evaluations. * at age group below 18 years old. * who refused to participate in the study. |
| 40 healthy patients | – | Other: participants are not assigned an intervention as part of the studyAn external control group will consist of age- and gender-matched individuals without any hematological disorders or significant cardiovascular conditions. They will be recruited from health care workers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adults aged 18-75 years Participants with MPN will be recruited from clinical Haematology Unit of the Internal Medicine at Assiut university while healthy participants will be recruited from health care workers Inclusion criteria of MPN patients will include individuals diagnosed with myeloproliferative neoplasms: essential thrombocythemia, Polycythemia vera and Primary myelofibrosis Exclusion criteria of MPN patients will encompass individuals with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) , patients who have experienced a myocardial infarction, stroke, heart failure, Hypertension, or significant cardiovascular event before diagnosis of MPN, Patients with severe comorbid conditions that could confound results, such as: Severe renal or hepatic impairment and Active malignancies other than MPN and pregnant and lactating women Study will take place in Assiut university hospitals
Key inclusion criteria (6 listed)
- patients with confirmed diagnosis of myeloproliferative neoplasms of one of the following:
- Essential thrombocythemia (ET)
- Polycythemia vera (PV)
- Primary myelofibrosis (PMF)
- Adults aged 18 years and older.
Key exclusion criteria (8 listed)
- Patients with secondary erythrocytosis or thrombocytosis due to other underlying conditions (e.g., chronic hypoxia, tumors) will be excluded.
- Patients who have experienced a myocardial infarction, stroke, heart failure, Hypertension, or significant cardiovascular event before diagnosis of MPN
- Patients with severe comorbid conditions that could confound results, such as:
- Severe renal or hepatic impairment
- Active malignancies other than MPN
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 |
|---|---|---|
| participants are not assigned an intervention as part of the studyAlso: participants are not assigned an intervention as part of the study.participants are not assigned an intervention as part of the study | Other | 40 MPN patients, 40 healthy patients |
Primary outcome
Prevalence of Cardiovascular Disease and cardiovascular Risk Factors
Time frame: through study completion, an average of 4 years
Assessment of clinical cardiovascular disease (CVD) through patient history, physical examination, and diagnostic tests (e.g., ECG, echocardiography) and Measurement of risk factors such as: * Blood pressure (systolic and diastolic) * Lipid profile (total cholesterol, LDL, HDL, triglycerides) * Body mass index (BMI) kg/m^2
1 secondary outcome
Subclinical Cardiovascular Manifestations and Comparison with the healthy control group
Time frame: through study completion, an average of 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 33907189Guglielmelli P, Gangat N, Coltro G, Lasho TL, Loscocco GG, Finke CM, Morsia E, Sordi B, Szuber N, Hanson CA, Pardanani A, Vannucchi AM, Tefferi A. Mutations and thrombosis in essential thrombocythemia. Blood Cancer J. 2021 Apr 27;11(4):77. doi: 10.1038/s41408-021-00470-y. No abstract available.
- Background: PubMed 31259299Leiva O, Bekendam RH, Garcia BD, Thompson C, Cantor A, Chitalia V, Ravid K. Emerging Factors Implicated in Fibrotic Organ-Associated Thrombosis: The Case of Two Organs. TH Open. 2019 Jun 7;3(2):e165-e170. doi: 10.1055/s-0039-1692204. eCollection 2019 Apr.
- Background: PubMed 26033810Hultcrantz M, Wilkes SR, Kristinsson SY, Andersson TM, Derolf AR, Eloranta S, Samuelsson J, Landgren O, Dickman PW, Lambert PC, Bjorkholm M. Risk and Cause of Death in Patients Diagnosed With Myeloproliferative Neoplasms in Sweden Between 1973 and 2005: A Population-Based Study. J Clin Oncol. 2015 Jul 10;33(20):2288-95. doi: 10.1200/JCO.2014.57.6652. Epub 2015 Jun 1.
- Background: PubMed 25037629Tefferi A, Guglielmelli P, Larson DR, Finke C, Wassie EA, Pieri L, Gangat N, Fjerza R, Belachew AA, Lasho TL, Ketterling RP, Hanson CA, Rambaldi A, Finazzi G, Thiele J, Barbui T, Pardanani A, Vannucchi AM. Long-term survival and blast transformation in molecularly annotated essential thrombocythemia, polycythemia vera, and myelofibrosis. Blood. 2014 Oct 16;124(16):2507-13; quiz 2615. doi: 10.1182/blood-2014-05-579136. Epub 2014 Jul 18.
- Background: PubMed 33731931Fidler TP, Xue C, Yalcinkaya M, Hardaway B, Abramowicz S, Xiao T, Liu W, Thomas DG, Hajebrahimi MA, Pircher J, Silvestre-Roig C, Kotini AG, Luchsinger LL, Wei Y, Westerterp M, Snoeck HW, Papapetrou EP, Schulz C, Massberg S, Soehnlein O, Ebert B, Levine RL, Reilly MP, Libby P, Wang N, Tall AR. The AIM2 inflammasome exacerbates atherosclerosis in clonal haematopoiesis. Nature. 2021 Apr;592(7853):296-301. doi: 10.1038/s41586-021-03341-5. Epub 2021 Mar 17.
- Background: PubMed 15003906Garypidou V, Vakalopoulou S, Dimitriadis D, Tziomalos K, Sfikas G, Perifanis V. Incidence of pulmonary hypertension in patients with chronic myeloproliferative disorders. Haematologica. 2004 Feb;89(2):245-6. No abstract available.
- Background: PubMed 34083781Briukhovetska D, Dorr J, Endres S, Libby P, Dinarello CA, Kobold S. Interleukins in cancer: from biology to therapy. Nat Rev Cancer. 2021 Aug;21(8):481-499. doi: 10.1038/s41568-021-00363-z. Epub 2021 Jun 3.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Philadelphia Negative Myeloproliferative Neoplasms, 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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 26 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viola Waheed Saeed (+20 109 605 0888, violawaheed2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Cardiovascular Disease and cardiovascular Risk Factors (time frame: through study completion, an average of 4 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 NCT06615414, 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 26 Sep 2024.