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
About this trial
This is an interventional diagnostic trial for Pulmonary Hypertension
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.
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
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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