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Status unknownNCT04843475Updated Apr 15, 2021

Study of Pulmonary Hypertension in Patients With Chronic Myeloproliferative Disorders at Sohag University Hospital

An observational study in Chronic Myeloproliferative Disorders, sponsored by Sohag University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-15.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years and older
Sex
All
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Study 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 (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

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Conditions studied

  • Chronic Myeloproliferative Disorders
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In context

Myeloproliferative Disorders

640 studies on the registry are indexed under Myeloproliferative Disorders; 111 are open to participants now.

This study's planned enrollment of 150 is close to the median of 143 across 113 observational studies indexed under Myeloproliferative Disorders.

Browse Myeloproliferative Disorders studies →

Lead sponsor

Sohag University is the lead sponsor of 1,218 studies on the registry; 627 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The outpatient Hematology Clinic at Sohag University Hospital.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • MPNs patients who have echocardiographic probability of PH.

    Diagnostic Test: Echocardiography

  • MPNs patients who do not have echocardiographic probability of PH

    Diagnostic Test: Echocardiography

Interventions

  • Diagnostic testEchocardiography

    Trans-thoracic Echocardiography

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What researchers measure

Primary outcomes

  1. Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients

    Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients

    Time frame: 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

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

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 26320113 ↗
  • Yaylali 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 32069470 ↗
  • Lopez-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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04843475
Lead sponsor
Sohag University
Responsible party
Mahmoud Hamdy Ahmed (assistant lecturer, Sohag University) — Principal investigator
First posted
Apr 13, 2021
Start date
May 1, 2021 (estimated)
Primary completion
Jan 1, 2023 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Apr 15, 2021

Study contacts

Mahmoud H Ahmed, Master
Contact
mahmoudhamdy@med.sohag.edu.eg
01003707775
Ali M Kassem, Professor
Contact
01003459738

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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