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Evaluation of Echocardiographic Indices and Blood Biomarkers in Group 1 Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
swan ganze catheter /echocardiography
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age>18 years old
  2. Patient diagnosed as group 1 PH.

Exclusion Criteria:

  1. Age under 18 years.
  2. Unwilling or unable to sign the informed consent form.
  3. Hemodynamically unstable condition requiring inotropic or vasoactive drugs.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    pulmonary hypertension group 1

    Arm Description

    each patient will be submitted to : swan-ganze catheterization detailed echocardiography blood sample for biomarkers (troponin, uric acid and micro RNA)

    Outcomes

    Primary Outcome Measures

    Evaluation of echocardiographic indices in Group 1 pulmonary hypertension
    All trans thoracic echocardiographic indices will be measured: peak tricuspid regurgitation velocity (m/s). right ventricular outflow acceleration time (msec). peak early pulmonary regurgitation velocity (m/s). peak late pulmonary regurgitation velocity (m/s) . tricuspid regurgitation time velocity integral (m/s). tricuspid annulus tissue Doppler image . right ventricle morphology and functions. left ventricle morphology and functions.
    Evaluation of serum troponin level in Group 1 pulmonary hypertension
    Blood samples from pulmonary circulation will be obtained for troponin level
    Evaluation of serum uric acid in Group 1 pulmonary hypertension
    Blood samples from pulmonary circulation will be obtained for serum uric acid.

    Secondary Outcome Measures

    Evaluation of mRNA level in Group 1 pulmonary hypertension
    Blood samples from pulmonary circulation will be obtained for mRNA level

    Full Information

    First Posted
    February 9, 2020
    Last Updated
    February 19, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04279145
    Brief Title
    Evaluation of Echocardiographic Indices and Blood Biomarkers in Group 1 Pulmonary Hypertension
    Official Title
    Evaluation of Echocardiographic Indices and Blood Biomarkers in Group 1 Pulmonary Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 1, 2020 (Anticipated)
    Primary Completion Date
    March 1, 2023 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    To evaluate different echocardiographic indices in diagnosis and follow up of group 1 pulmonary hypertension. To evaluate blood biomarkers (troponin, uric acid and micro RNA) in naïve group 1 pulmonary hypertension.
    Detailed Description
    Introduction: Pulmonary hypertension is pathophysiological condition defined as increases of mean pulmonary artery pressure above 20 mmHg as assessed by right heart catheterization (RHC) (1). As pulmonary hypertension has a variety of causes with different clinical presentations and characteristics; it is classified into five clinical groups (2): Group 1 and also called pulmonary arterial hypertension group. Group 2 due to left sided heart diseases. Group 3 caused by chronic lung diseases and hypoxemia. Group 4 caused by chronic pulmonary artery occlusions. Group 5 that has unclear and multifactorial causes. Although group 1 less common; it is carrying significant clinical importance as early detection can improve the patient's outcome through providing them the available vasodilator medications. To diagnose patient in group 1 PH, the patient should have RHC (3) to obtain the definite hemodynamic before starting treatment as advised by PH guidelines, however RHC is invasive and expensive procedure and carrying some bad drawback (4). Transthoracic echocardiography is less expensive, non-invasive and nonhazardous procedure and commonly provide significant parameters before RHC (5). several echocardiographic indices correlate significantly with RHC hemodynamic, as peak tricuspid regurgitation velocity , right ventricular outflow acceleration time, peak early pulmonary regurgitation velocity , peak late pulmonary regurgitation velocity, tricuspid regurgitation time velocity integral ,and tricuspid annulus tissue Doppler image velocities. Most of these parameters used individually to echocardiographic diagnose PH, however little data available to integrate them together to echocardiographic diagnose PH in group1; integrations of theses parameters might improve PH diagnosis As pulmonary arterial hypertension is Patho biological disease, and affecting small pulmonary arteries and arterioles, the pathologic pattern of vascular lesions is characterized by intimal hyperplasia, medial thickness, plexiform lesions, and thrombosis in situ, and is caused by increased migration and proliferation of smooth muscle cells (SMCs) and adventitial fibroblasts, abnormal endothelial cell proliferation, and impaired apoptosis (6). several biomarkers play significant role in pathogenesis and prognosis of the diseases, serum uric acid (7,8) and serum troponin (9) may increase in PH and may affecting the clinical severity however further studies needed to confirm this . Also micro RNA new marker of assessing cardiovascular diseases , may have role in assessing group 1 pulmonary hypertension(10).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    patients with primary pulmonary hypertension will submitted to : swanganz cath. detailed echocadiography blood samples for bio markers
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    pulmonary hypertension group 1
    Arm Type
    Experimental
    Arm Description
    each patient will be submitted to : swan-ganze catheterization detailed echocardiography blood sample for biomarkers (troponin, uric acid and micro RNA)
    Intervention Type
    Device
    Intervention Name(s)
    swan ganze catheter /echocardiography
    Intervention Description
    Right heart catheterization and mixed venous blood samples will be obtained for ABG, biomarkers (troponin , uric acid and micro RNA). Each subject will have echocardiography, 6 MWD, clinical functional class and blood sample at the day of right heart catheterization or at least less than week of right heart catheterization
    Primary Outcome Measure Information:
    Title
    Evaluation of echocardiographic indices in Group 1 pulmonary hypertension
    Description
    All trans thoracic echocardiographic indices will be measured: peak tricuspid regurgitation velocity (m/s). right ventricular outflow acceleration time (msec). peak early pulmonary regurgitation velocity (m/s). peak late pulmonary regurgitation velocity (m/s) . tricuspid regurgitation time velocity integral (m/s). tricuspid annulus tissue Doppler image . right ventricle morphology and functions. left ventricle morphology and functions.
    Time Frame
    baseline
    Title
    Evaluation of serum troponin level in Group 1 pulmonary hypertension
    Description
    Blood samples from pulmonary circulation will be obtained for troponin level
    Time Frame
    baseline
    Title
    Evaluation of serum uric acid in Group 1 pulmonary hypertension
    Description
    Blood samples from pulmonary circulation will be obtained for serum uric acid.
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Evaluation of mRNA level in Group 1 pulmonary hypertension
    Description
    Blood samples from pulmonary circulation will be obtained for mRNA level
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age>18 years old Patient diagnosed as group 1 PH. Exclusion Criteria: Age under 18 years. Unwilling or unable to sign the informed consent form. Hemodynamically unstable condition requiring inotropic or vasoactive drugs.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Moustafa Hosny Abdelmegeed
    Phone
    +201007787355
    Email
    mido.elhawary.d6490@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    safaa mokhtar
    Phone
    +201224142884
    Email
    safaa_wafy@hotmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30545968
    Citation
    Simonneau G, Montani D, Celermajer DS, Denton CP, Gatzoulis MA, Krowka M, Williams PG, Souza R. Haemodynamic definitions and updated clinical classification of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801913. doi: 10.1183/13993003.01913-2018. Print 2019 Jan.
    Results Reference
    background
    PubMed Identifier
    15194173
    Citation
    Simonneau G, Galie N, Rubin LJ, Langleben D, Seeger W, Domenighetti G, Gibbs S, Lebrec D, Speich R, Beghetti M, Rich S, Fishman A. Clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2004 Jun 16;43(12 Suppl S):5S-12S. doi: 10.1016/j.jacc.2004.02.037.
    Results Reference
    background
    PubMed Identifier
    23662190
    Citation
    Voelkel NF, Gomez-Arroyo J, Abbate A, Bogaard HJ. Mechanisms of right heart failure-A work in progress and a plea for failure prevention. Pulm Circ. 2013 Jan;3(1):137-43. doi: 10.4103/2045-8932.109957. No abstract available.
    Results Reference
    background
    PubMed Identifier
    9778486
    Citation
    Voelkel NF, Tuder RM. Cellular and molecular biology of vascular smooth muscle cells in pulmonary hypertension. Pulm Pharmacol Ther. 1997 Oct-Dec;10(5-6):231-41. doi: 10.1006/pupt.1998.0100. No abstract available.
    Results Reference
    background
    PubMed Identifier
    12587962
    Citation
    Bendayan D, Shitrit D, Ygla M, Huerta M, Fink G, Kramer MR. Hyperuricemia as a prognostic factor in pulmonary arterial hypertension. Respir Med. 2003 Feb;97(2):130-3. doi: 10.1053/rmed.2003.1440.
    Results Reference
    background
    PubMed Identifier
    20412051
    Citation
    Filusch A, Giannitsis E, Katus HA, Meyer FJ. High-sensitive troponin T: a novel biomarker for prognosis and disease severity in patients with pulmonary arterial hypertension. Clin Sci (Lond). 2010 Jun 2;119(5):207-13. doi: 10.1042/CS20100014.
    Results Reference
    background
    PubMed Identifier
    20051913
    Citation
    Crosswhite P, Sun Z. Nitric oxide, oxidative stress and inflammation in pulmonary arterial hypertension. J Hypertens. 2010 Feb;28(2):201-12. doi: 10.1097/HJH.0b013e328332bcdb.
    Results Reference
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    Evaluation of Echocardiographic Indices and Blood Biomarkers in Group 1 Pulmonary Hypertension

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