Evaluation of Echocardiographic Indices and Blood Biomarkers in Group 1 Pulmonary Hypertension
1 other identifier
interventional
35
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2020
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2020
CompletedFirst Posted
Study publicly available on registry
February 21, 2020
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFebruary 21, 2020
February 1, 2020
3 years
February 9, 2020
February 19, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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.
baseline
Evaluation of serum troponin level in Group 1 pulmonary hypertension
Blood samples from pulmonary circulation will be obtained for troponin level
baseline
Evaluation of serum uric acid in Group 1 pulmonary hypertension
Blood samples from pulmonary circulation will be obtained for serum uric acid.
baseline
Secondary Outcomes (1)
Evaluation of mRNA level in Group 1 pulmonary hypertension
baseline
Study Arms (1)
pulmonary hypertension group 1
EXPERIMENTALeach patient will be submitted to : swan-ganze catheterization detailed echocardiography blood sample for biomarkers (troponin, uric acid and micro RNA)
Interventions
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
Eligibility Criteria
You may qualify if:
- Age\>18 years old
- Patient diagnosed as group 1 PH.
You may not qualify if:
- Age under 18 years.
- Unwilling or unable to sign the informed consent form.
- Hemodynamically unstable condition requiring inotropic or vasoactive drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
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.
PMID: 30545968BACKGROUNDSimonneau 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.
PMID: 15194173BACKGROUNDVoelkel 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.
PMID: 23662190BACKGROUNDVoelkel 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.
PMID: 9778486BACKGROUNDBendayan 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.
PMID: 12587962BACKGROUNDFilusch 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.
PMID: 20412051BACKGROUNDCrosswhite 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.
PMID: 20051913BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2020
First Posted
February 21, 2020
Study Start
March 1, 2020
Primary Completion
March 1, 2023
Study Completion
April 1, 2023
Last Updated
February 21, 2020
Record last verified: 2020-02