Pulmonary HypertensionNCT04279145
Evaluation of Echocardiographic Indices and Blood Biomarkers in Group 1 Pulmonary Hypertension
A study testing swan ganze catheter /echocardiography in people with Pulmonary Hypertension, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- swan ganze catheter /echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age>18 years old
- Patient diagnosed as group 1 PH.
Who cannot join
- Age under 18 years.
- Unwilling or unable to sign the informed consent form.
- Hemodynamically unstable condition requiring inotropic or vasoactive drugs.
Trial locations and contacts
No sites are listed yet.
About this study
- 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.
Read the 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).
- Conditions
- Pulmonary Hypertension
- Being tested
- swan ganze catheter /echocardiography
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
swan ganze catheter /echocardiographyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| pulmonary hypertension group 1 | Experimental | each patient will be submitted to : swan-ganze catheterization detailed echocardiography blood sample for biomarkers (troponin, uric acid and micro RNA) Receives: Device: swan ganze catheter /echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Evaluation of serum troponin level in Group 1 pulmonary hypertension
Blood samples from pulmonary circulation will be obtained for troponin level
Measured: baseline
Evaluation of serum uric acid in Group 1 pulmonary hypertension
Blood samples from pulmonary circulation will be obtained for serum uric acid.
Measured: baseline
Secondary outcomes (1)
Evaluation of mRNA level in Group 1 pulmonary hypertension
Blood samples from pulmonary circulation will be obtained for mRNA level
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Mar 2020 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients with primary pulmonary hypertension will submitted to : swanganz cath. detailed echocadiography blood samples for bio markers
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustafa Hosny Abdelmegeed Aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279145
- Sponsor's protocol ID
- group 1 PH
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30545968Simonneau 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.
PubMed 15194173Voelkel 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.
PubMed 23662190Voelkel 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.
PubMed 9778486Bendayan 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.
PubMed 12587962Filusch 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.
PubMed 20412051Crosswhite 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.
PubMed 20051913
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Echocardiographic Indices and Blood Biomarkers in Group 1 Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT04279145
- Acronym / sponsor ID
- group 1 PH
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with primary pulmonary hypertension will submitted to : swanganz cath. detailed echocadiography blood samples for bio markers
| Arm | Type | Receives |
|---|---|---|
| pulmonary hypertension group 1 | Experimental | Device: swan ganze catheter /echocardiographyeach patient will be submitted to : swan-ganze catheterization detailed echocardiography blood sample for biomarkers (troponin, uric acid and micro RNA) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18 years old
- Patient diagnosed as group 1 PH.
Key exclusion criteria (3 listed)
- Age under 18 years.
- Unwilling or unable to sign the informed consent form.
- Hemodynamically unstable condition requiring inotropic or vasoactive drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| swan ganze catheter /echocardiographyRight 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 | Device | pulmonary hypertension group 1 |
Primary outcome
Evaluation of echocardiographic indices in Group 1 pulmonary hypertension
Time frame: baseline
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
Time frame: baseline
Blood samples from pulmonary circulation will be obtained for troponin level
Evaluation of serum uric acid in Group 1 pulmonary hypertension
Time frame: baseline
Blood samples from pulmonary circulation will be obtained for serum uric acid.
1 secondary outcome
Evaluation of mRNA level in Group 1 pulmonary hypertension
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Background: PubMed 30545968Simonneau 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.
- Background: PubMed 15194173Simonneau 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.
- Background: PubMed 23662190Voelkel 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.
- Background: PubMed 9778486Voelkel 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.
- Background: PubMed 12587962Bendayan 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.
- Background: PubMed 20412051Filusch 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.
- Background: PubMed 20051913Crosswhite 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.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing swan ganze catheter /echocardiography in people with Pulmonary Hypertension, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moustafa Hosny Abdelmegeed (+201007787355, mido.elhawary.d6490@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of echocardiographic indices in Group 1 pulmonary hypertension (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279145, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.