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

NCT ID: NCT04279145

Last Updated: 2020-02-21

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-04-30

Brief Summary

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* 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

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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).

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

patients with primary pulmonary hypertension will submitted to : swanganz cath. detailed echocadiography blood samples for bio markers
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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pulmonary hypertension group 1

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

Group Type EXPERIMENTAL

swan ganze catheter /echocardiography

Intervention Type DEVICE

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

Interventions

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swan ganze catheter /echocardiography

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Moustafa Hosny Abdelmegeed Aly

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Moustafa Hosny Abdelmegeed

Role: CONTACT

+201007787355

safaa mokhtar

Role: CONTACT

+201224142884

References

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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.

Reference Type BACKGROUND
PMID: 30545968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15194173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23662190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9778486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12587962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20412051 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20051913 (View on PubMed)

Other Identifiers

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group 1 PH

Identifier Type: -

Identifier Source: org_study_id

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