Prevalence and Risk Factors of Pulmonary Hypertension in Patients with Myeloproliferative Neoplasms in Assiut University Hospital.

NCT ID: NCT06647706

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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

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Myeloproliferative Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MPNs patients who have echocardiographic probability of PH

MPNs patients who have echocardiographic probability of PH

Transthoracic echocardiography

Intervention Type DEVICE

MPNs patients who have echocardiographic probability of PH

MPNs patients who do not have echocardiographic probability of PH

MPNs patients who do not have echocardiographic probability of PH

Transthoracic echocardiography

Intervention Type DEVICE

MPNs patients who have echocardiographic probability of PH

Interventions

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Transthoracic echocardiography

MPNs patients who have echocardiographic probability of PH

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Adult patients (≥18 years)
2. patients diagnosed with MPNs. including polycythemia vera (PV), essential thrombocythemia (ET), chronic myeloid leukemia (CML), and primary myelofibrosis (PMF)

Exclusion Criteria

1. patients less than 18 years old.
2. patients with cardiac diseases involving the left side of the heart or congenital heart diseases.
3. patients with chronic lung disease and primary pulmonary hypertension.
4. patients with chronic kidney disease.
5. patients with inherited and acquired chronic hemolytic anemia.
6. patients with connective tissue diseases.
7. patients with with past or current pulmonary embolism.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrhman Khalaf Hadyia Mohamed

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Abdelrhman khalaf mohamed, master

Role: CONTACT

+2001016901852

Mohamed Ramadan Abdelhameed, PhD

Role: CONTACT

+2001097510010

References

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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.

Reference Type BACKGROUND
PMID: 36028254 (View on PubMed)

Ferrari 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.

Reference Type BACKGROUND
PMID: 33135220 (View on PubMed)

Lafitte 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.

Reference Type BACKGROUND
PMID: 23510536 (View on PubMed)

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. 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.

Reference Type BACKGROUND
PMID: 26318161 (View on PubMed)

Lahm 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.

Reference Type BACKGROUND
PMID: 24267303 (View on PubMed)

Simonneau 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.

Reference Type BACKGROUND
PMID: 24355639 (View on PubMed)

Arber 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.

Reference Type BACKGROUND
PMID: 27069254 (View on PubMed)

Other Identifiers

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Prevalence of PH in MPNs

Identifier Type: -

Identifier Source: org_study_id

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