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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04279145
Enrollment
35
Registered
2020-02-21
Start date
2020-03-01
Completion date
2023-04-30
Last updated
2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

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).

Interventions

DEVICEswan 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of echocardiographic indices in Group 1 pulmonary hypertensionbaselineAll 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 hypertensionbaselineBlood samples from pulmonary circulation will be obtained for troponin level
Evaluation of serum uric acid in Group 1 pulmonary hypertensionbaselineBlood samples from pulmonary circulation will be obtained for serum uric acid.

Secondary

MeasureTime frameDescription
Evaluation of mRNA level in Group 1 pulmonary hypertensionbaselineBlood samples from pulmonary circulation will be obtained for mRNA level

Contacts

Primary ContactMoustafa Hosny Abdelmegeed
mido.elhawary.d6490@gmail.com+201007787355
Backup Contactsafaa mokhtar
safaa_wafy@hotmail.com+201224142884

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026