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

Chronic Myeloproliferative Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04843475
• Other study ID #: Soh-Med-21-04-15
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2021
• Source: Sohag University
• Contact: Mahmoud H Ahmed, Master
• Phone: 01003707775
• Email: mahmoudhamdy[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• 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.

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Hypertension
• Hypertension, Pulmonary
• Myeloproliferative Disorders

Intervention

Diagnostic Test:
• Echocardiography
Trans-thoracic Echocardiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (3)

Galiè 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients	Prevalence of pulmonary hypertension in chronic myeloproliferative disorders patients	2 years
Secondary	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	2 years