NCT06647706

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 16, 2024

Last Update Submit

October 17, 2024

Conditions

Keywords

pulmonary HTNMPNs

Outcome Measures

Primary Outcomes (1)

  • 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 ))

    1 year

Secondary Outcomes (1)

  • predictors of pulmonary hypertension in MPNs patients

    1 year

Study Arms (2)

MPNs patients who have echocardiographic probability of PH

MPNs patients who have echocardiographic probability of PH

Device: Transthoracic echocardiography

MPNs patients who do not have echocardiographic probability of PH

MPNs patients who do not have echocardiographic probability of PH

Device: Transthoracic echocardiography

Interventions

MPNs patients who have echocardiographic probability of PH

MPNs patients who do not have echocardiographic probability of PHMPNs patients who have echocardiographic probability of PH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Assiut University Hospitals. (internal medicine Department and Outpatient Hematology Clinic )

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 36028254BACKGROUND
  • 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.

    PMID: 33135220BACKGROUND
  • 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.

    PMID: 23510536BACKGROUND
  • 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.

    PMID: 26318161BACKGROUND
  • 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.

    PMID: 24267303BACKGROUND
  • 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.

    PMID: 24355639BACKGROUND
  • 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.

    PMID: 27069254BACKGROUND

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Abdelrhman khalaf mohamed, master

CONTACT

Mohamed Ramadan Abdelhameed, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 18, 2024

Study Start

November 1, 2024

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

October 18, 2024

Record last verified: 2024-10