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      string(196) "NCT00706082 - A Two-stage Prospective Observational Cohort Study in Scleroderma Patients to Evaluate Screening Tests and the Incidence of Pulmonary Arterial Hypertension and Pulmonary Hypertension"
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  ["project_title"]=>
  string(115) "Reassessment of the 2022 ESC/ERS echocardiographic algorithm to detect pulmonary hypertension in systemic sclerosis"
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  string(622) "Pulmonary hypertension (PH) is a serious condition that can be life-threatening if not detected early. Recent changes in how PH is diagnosed raise concerns about whether current screening methods remain reliable, particularly for patients with systemic sclerosis (SSc), who are at high risk. Using data from the DETECT study, this project evaluates the accuracy of the 2022 ESC/ERS screening algorithm and tries to identify more adequate cut-offs. By comparing it to other strategies, we aim to improve PAH detection, ensuring better care for SSc patients and others at risk, ultimately enhancing public health strategies."
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  array(7) {
    ["first_name"]=>
    string(10) "Sébastien"
    ["last_name"]=>
    string(6) "SANGES"
    ["degree"]=>
    string(6) "MD PhD"
    ["primary_affiliation"]=>
    string(20) "Université de Lille"
    ["email"]=>
    string(30) "sebastien.sanges@univ-lille.fr"
    ["state_or_province"]=>
    string(15) "Hauts-de-France"
    ["country"]=>
    string(6) "France"
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      string(7) "MORTAIN"
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1689) "Background: Pulmonary hypertension (PH) is a severe complication of systemic sclerosis (SSc), requiring early detection through systematic screening. Recent changes in PH diagnosis criteria, lowering the mean pulmonary arterial pressure (mPAP) threshold to 20 mmHg, require reassessment of existing screening strategies. The ESC/ERS 2022 echocardiographic algorithm has been validated with the new definition in high-risk patients but not for systematic screening in asymptomatic SSc patients.



Objective: To evaluate the diagnostic accuracy of the ESC/ERS 2022 echocardiographic algorithm for PH screening in SSc patients using the updated hemodynamic definition.



Study Design: Retrospective analysis of SSc patients from the DETECT study, assessing echocardiographic signs of PH against hemodynamic confirmation via right heart catheterization (RHC).



Participants: All patients from the original DETECT trial (SSc patients that underwent systematic RHC), with no exclusion criteria.



Primary and Secondary Outcome Measure(s):



Primary Outcome: Diagnostic accuracy of echocardiographic classification of PH risk by the ESC/ERS 2022 algorithm to predict PH defined by RHC in SSc patients 



Secondary Outcome: Diagnostic accuracy of individual echocardiographic parameters (e.g., tricuspid regurgitant jet velocity, right atrial/ventricular dimensions) to predict PH defined by RHC in SSc patients.



Statistical Analysis: Computation of diagnostic accuracy metrics (area under receiver operator Characteristic curve (AUC), sensitivity, specificity, positive and negative predictive values)."
  ["project_brief_bg"]=>
  string(2208) "Pulmonary hypertension (PH) is a frequent and severe complication of systemic sclerosis (SSc) (1). Prognosis is improved by early diagnosis, which is facilitated by a systematic annual screening program (2). The optimal screening modality for PH in SSc is still debated, with various strategies developed over the years (3). Recently, the hemodynamic definition of PH has been modified, with a lowering of the mean pulmonary arterial pressure (mPAP) threshold at 20 mmHg, and the introduction of a pulmonary vascular resistance (PVR) criterion for pre-capillary PH (4); requiring a reassessment of previously established screening algorithms.

The DETECT algorithm has been validated as a 2-step strategy to screen for PH in a population of SSc patients that underwent systematic right-heart catheterization (RHC) (5). While originally designed with the previous definition of PH, its performance has recently been re-evaluated on the same cohort using the updated hemodynamic criteria (6). In this setting, the DETECT algorithm was associated with an adequate sensitivity (88%), but with unsatisfying rates of false positives (53%) and false negatives (12%) (6).

The European Society of Cardiology (ESC)/European Respiratory Society (ERS) 2022 guidelines also recommend estimating the echocardiographic probability of PH using a dedicated algorithm, relying on direct (tricuspid regurgitation velocity) and indirect (e.g. right atrial surface, right ventricle dimension and function) signs of elevated pulmonary pressures (4). This algorithm was recently reassessed using the new hemodynamic criteria in a cohort of PH patients referred for RHC, and retained its diagnostic accuracy despite the change in mPAP threshold (7). However, as this evaluation was performed on a population with high pre-test probability (patients addressed to the cath lab), it is unclear whether the same holds true in the case of systematic screening in asymptomatic SSc patients.

The objective of this work is to reassess the performance of the ESC/ERS 2022 echocardiographic algorithm in a cohort of SSc patients that underwent systematic RHC, in order to determine its diagnostic accuracy in this setting."
  ["project_specific_aims"]=>
  string(518) "The objectives of this project are:

1/ to assess the performance of the current ESC/ERS echocardiographic algorithm in discriminating patients with and without PH, using the updated hemodynamic definition (mPAP value > 20 mmhg), in a cohort of SSc patients with systematic hemodynamic evaluation

2/ to evaluate the diagnostic accuracy of direct and indirect echocardiographic signs of PH in predicting an mPAP value > 20 mmhg in this cohort, and identify new optimized cut-offs if necessary

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    ["label"]=>
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  ["project_purposes"]=>
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      ["label"]=>
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  ["project_research_methods"]=>
  string(143) "The patient sample for this study will include all the patients from the original DETECT trial. There is no exclusion criterion for this study."
  ["project_main_outcome_measure"]=>
  string(778) "Outcome measure for objective 1:  Diagnostic accuracy (sensitivity, specificity, positive and negative predictive values) of the classification of the echocardiographic probability of PH by the ESC/ERS 2022 algorithm to predict PH as determined by RHC as gold standard



Outcome measures for objective 2: Diagnostic accuracy (sensitivity, specificity, AUC, positive negative predictive values) of echocardiographic signs of PH (tricuspid regurgitant jet velocity; tricuspid annular plane systolic excursion (TAPSE); right atrium (RA) area; right ventricle (RV) area; pulmonary regurgitant velocity; RV diameter; left ventricle (LV) end-diastolic dimension; LV end-systolic dimension; inferior vena cava; interventricular septum) to predict PH status defined by RHC "
  ["project_main_predictor_indep"]=>
  string(804) "Main predictor for objective 1: 

Classification of the echocardiographic probability of PH by the ESC/ERS 2022 algorithm (3-level categorical variable: low vs. intermediate vs. high risk) and PH status as determined RHC (mPAP value>20 mmg) as gold standard



Main predictors for objective 2: 

Direct and indirect signs of PH (tricuspid regurgitant jet velocity; tricuspid annular plane systolic excursion (TAPSE); right atrium (RA) area; right ventricle (RV) area; pulmonary regurgitant velocity; RV diameter; left ventricle (LV) end-diastolic dimension; LV end-systolic dimension; inferior vena cava; interventricular septum) as measured by echocardiography according to standardized procedures (all quantitative variables) and PH status as determined RHC as gold standard."
  ["project_other_variables_interest"]=>
  string(165) "In the context of this study, all 112 variables collected during the DETECT trial will be needed to describe the patient sample and/or adjust the performed analyses."
  ["project_stat_analysis_plan"]=>
  string(1738) "Categorical variables will be described using frequencies and percentages and quantitative variables will be summarized using the mean and standard deviation or median and interquartile range (IQR) in case of non-normal distribution. The normality of distributions will be assessed through graphical representations and the Shapiro-Wilk test. For each variable, the number of missing data will be reported.



To answer to primary objective, a contingency table between classification of ESC/ERS 2022 algorithm and PH status determined by RHC will be established. From this table, the diagnostic accuracy (sensitivity, specificity, negative and positive predictive values) of classification of ESC/ERS 2022 algorithm to predict PH as determined by RHC will be determined with theirs 95% confidence intervals (CIs). Primary analysis will be done by considering high vs. low and intermediate risk pooled together and secondary analysis will be done by considering high and intermediate pooled together vs. low risk. 



To answer to primary objective, the diagnostic performance of each individual echocardiographic parameters included in the ESC/ERS algorithm to predict PH will be determined. The diagnostic accuracy of the pre-specified threshold used in the ESC/ERS algorithm will be calculated with theirs 95%CIs. We will also determine the AUC of each parameters to predicted PH, and determined the optimal cut-off value by maximizing the Youden index; diagnostic accuracy associated with optimal cut-off values will be reported. 



All analyses will be done using complete available cases and will be repeated after handling missing values by multiple imputation procedure (sensitivity analysis)."
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  ["project_timeline"]=>
  string(187) "Anticipated start date: October 1st, 2025

Analysis completion date: M6

Manuscript drafted and first submission: M12

Report of results to the YODA project: M12

"
  ["project_dissemination_plan"]=>
  string(413) "The results generated in this project will be presented in national and international conferences of rheumatology (EULAR and ACR), cardiology (ESC and AHA) and pulmonology (ERS and ATS) societies.



They will also be submitted for publication in high-impact, peer-reviewed journals in the same fields (Annals of the Rheumatic Diseases, Arthritis and Rheumatology, European Respiratory Journal, Chest)"
  ["project_bibliography"]=>
  string(1836) "

Lefèvre G, Dauchet L, Hachulla E, Montani D, Sobanski V, Lambert M, et al. Survival and Prognostic Factors in Systemic Sclerosis-Associated Pulmonary Hypertension: A Systematic Review and Meta-Analysis: Survival and Prognosis in SSc-Associated Pulmonary Hypertension. Arthritis Rheum. 2013 Sep;65(9):2412–23.
Hachulla E, Gressin V, Guillevin L, Carpentier P, Diot E, Sibilia J, et al. Early detection of pulmonary arterial hypertension in systemic sclerosis: A French nationwide prospective multicenter study. Arthritis Rheum. 2005 Dec 1;52(12):3792–800.
Hao Y, Thakkar V, Stevens W, Morrisroe K, Prior D, Rabusa C, et al. A comparison of the predictive accuracy of three screening models for pulmonary arterial hypertension in systemic sclerosis. Arthritis Res Ther. 2015 Jan 18;17(1):7.
Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, et al. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Heart J. 2022 Oct 11;43(38):3618–731.
Coghlan JG, Denton CP, Grünig E, Bonderman D, Distler O, Khanna D, et al. Evidence-based detection of pulmonary arterial hypertension in systemic sclerosis: the DETECT study. Ann Rheum Dis. 2014 Jul;73(7):1340–9.
Distler O, Bonderman D, Coghlan JG, Denton CP, Grünig E, Khanna D, et al. Performance of DETECT Pulmonary Arterial Hypertension Algorithm According to the Hemodynamic Definition of Pulmonary Arterial Hypertension in the 2022 European Society of Cardiology and the European Respiratory Society Guidelines. Arthritis Rheumatol Hoboken NJ. 2024 May;76(5):777–82.
D’Alto M, Di Maio M, Romeo E, Argiento P, Blasi E, Di Vilio A, et al. Echocardiographic probability of pulmonary hypertension: a validation study. Eur Respir J. 2022 Aug;60(2):2102548.

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