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      ["post_date"]=>
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      ["post_title"]=>
      string(174) "NCT02558231 - The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (TRITON)"
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      string(0) ""
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      string(170) "nct02558231-the-efficacy-and-safety-of-initial-triple-versus-initial-dual-oral-combination-therapy-in-patients-with-newly-diagnosed-pulmonary-arterial-hypertension-triton"
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  ["project_title"]=>
  string(135) "Right Ventricular-Pulmonary Arterial Coupling and Outcomes in Pulmonary Arterial Hypertension: A Retrospective Analysis of TRITON trial"
  ["project_narrative_summary"]=>
  string(812) "Pulmonary arterial hypertension (PAH) is a serious disease in which high blood pressure in the lung arteries strains the heart and can lead to heart failure. Treatments improve blood flow, but it is not always clear which therapies provide the greatest benefit. This study will re-analyze data from the TRITON clinical trial, which compared starting PAH treatment with two medications versus three medications in newly diagnosed patients. Although both strategies improved standard measurements, patients receiving three medications showed signs of better heart function. This analysis will examine newer measures of blood vessel flexibility and heart performance to better understand treatment response. Results may help improve how PAH treatments are chosen and monitored, leading to better long-term outcomes."
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  ["principal_investigator"]=>
  array(7) {
    ["first_name"]=>
    string(8) "Nafis A."
    ["last_name"]=>
    string(12) "Shamsid-Deen"
    ["degree"]=>
    string(2) "MD"
    ["primary_affiliation"]=>
    string(21) "University of Arizona"
    ["email"]=>
    string(20) "nshamsid@arizona.edu"
    ["state_or_province"]=>
    string(2) "AZ"
    ["country"]=>
    string(13) "United States"
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      ["p_pers_f_name"]=>
      string(7) "Ashwini"
      ["p_pers_l_name"]=>
      string(6) "Ronghe"
      ["p_pers_degree"]=>
      string(2) "MD"
      ["p_pers_pr_affil"]=>
      string(21) "University of Arizona"
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      ["requires_data_access"]=>
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    ["label"]=>
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  ["property_scientific_abstract"]=>
  string(1659) "Background: TRITON showed that initial dual and triple oral therapy produced similar 26-week PVR reductions, yet triple therapy demonstrated consistent directional advantages in mPAP, cardiac index, stroke volume and clinical-worsening events. Because PVR incompletely reflects pulmonary arterial stiffness and RV--PA coupling, metrics such as pulmonary arterial compliance (PAC), RC time, and stroke volume index (SVI) may better detect early reverse remodeling and physiologic benefit.



Objectives: To determine whether PAC, RC time, and SVI provide incremental prognostic value beyond PVR and whether initial triple therapy preferentially improves these stiffness-based indices in newly diagnosed PAH.



Study Design: Retrospective secondary analysis of TRITON individual participant data at baseline, 12 weeks, and 26 weeks.



Participants: Adults with incident Group 1 PAH (IPAH or CTD-PAH) randomized to initial dual therapy (macitentan + tadalafil) or initial triple therapy (macitentan + tadalafil + selexipag).



Primary Outcomes: PAC, RC time, and SVI and their changes over time.

Secondary Outcomes: Changes in mPAP, CO, SV, and PVR; achievement of prespecified low risk PAC/SVI/RC-time thresholds in dual vs triple therapy; associations between changes in PAC/RC time/SVI and 6MWD, WHO functional class along with time to clinical worsening.



Statistical Analysis: Mixed-effects models will assess longitudinal hemodynamics; Cox models will evaluate time-to-event outcomes; correlations will test relationships between stiffness-based indices and clinical response.

"
  ["project_brief_bg"]=>
  string(2023) "TRITON demonstrated that both initial dual and triple oral therapy produce large improvements in PVR at 26 weeks, with no statistically significant difference in PVR reduction between groups. However, multiple numerical signals consistently favored triple therapy: greater reductions in PVR and mPAP, larger increases in cardiac index and stroke volume, deeper NT-proBNP reductions, numerically greater 6MWD gains, and fewer clinical-worsening events, despite the trial being underpowered and of relatively short duration. These trends suggest that early prostacyclin pathway activation may confer additional benefit that is not fully captured by PVR alone.



PVR is a composite measure of afterload but only partially reflects pulmonary arterial remodeling and stiffness, which are central to long-term RV load and outcomes. Indices that better approximate vascular structure and load distribution such as PAC (stroke volume / pulse pressure), RC time (PVR x PAC), and stroke volume index (SVI) may be more sensitive markers of treatment effect, particularly in the context of early, aggressive therapy. If triple therapy preferentially improves PAC and preserves RC time, this could indicate more favorable reverse remodeling and RV--pulmonary artery coupling than what is apparent from PVR alone. Evaluating these metrics in TRITON may uncover a mechanistic advantage of triple therapy that explains the observed directional benefits in functional and biomarker endpoints, even in the absence of a statistically significant difference in PVR.



Demonstrating incremental prognostic value of PAC and RC time beyond PVR could:

1)Refine risk-based initial therapy decisions (e.g., which patients warrant immediate triple therapy).

2)Support incorporation of compliance- and coupling-based metrics into future PAH treatment algorithms.

3)Provide mechanistic insight into why triple therapy may improve long-term outcomes even when short-term PVR differences are modest.

"
  ["project_specific_aims"]=>
  string(1395) "Question: Does pulmonary arterial compliance (PAC) and RC time provide incremental prognostic value beyond PVR alone in newly diagnosed PAH patients receiving initial triple therapy in TRITON?



Objective: To determine whether PAC, RC time, and SVI provide incremental prognostic information beyond PVR and whether initial triple therapy preferentially improves these metrics in newly diagnosed Group 1 PAH.



Aim 1: Compare longitudinal changes in PAC, RC time, and SVI at baseline, 12 weeks, and 26 weeks between dual and triple therapy.



Hypothesis 1: Triple therapy will result in greater increases in PAC, preservation of RC time, and larger improvements in SVI, consistent with enhanced vascular and RV--PA reverse remodeling.



Aim 2: Evaluate relationships between changes in PAC/RC time/SVI and clinical endpoints.



Hypothesis 2: Improvements in PAC, RC time, and SVI will correlate more strongly with 6MWD gains, WHO functional class improvement and reduced clinical-worsening risk than changes in PVR.



Aim 3: Assess prognostic value beyond PVR.



Hypothesis 3: PAC and RC time will provide incremental prognostic value beyond PVR for predicting treatment response and short-term outcomes, identifying physiologic benefits of early prostacyclin-pathway activation not captured by PVR alone."
  ["project_study_design"]=>
  array(2) {
    ["value"]=>
    string(14) "indiv_trial_an"
    ["label"]=>
    string(25) "Individual trial analysis"
  }
  ["project_purposes"]=>
  array(1) {
    [0]=>
    array(2) {
      ["value"]=>
      string(56) "new_research_question_to_examine_treatment_effectiveness"
      ["label"]=>
      string(114) "New research question to examine treatment effectiveness on secondary endpoints and/or within subgroup populations"
    }
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  ["project_research_methods"]=>
  string(2123) "The inclusion and exclusion criteria is the same as the criteria specified in TRITON trial.



TRITON INCLUSION CRITERIA:

1)Age >=18 years at randomization.

2)Confirmed diagnosis of pulmonary arterial hypertension (PAH, WHO Group 1 by right-heart catheterization.

3)PAH hemodynamic criteria (per protocol): Mean pulmonary arterial pressure (mPAP) >=25 mmHg, Pulmonary artery wedge pressure (PAWP) =6 Wood units

4)Treatment-naïve PAH (no prior PAH-specific drugs).

5)PAH etiologies permitted: Idiopathic PAH (IPAH), Heritable PAH, Drug- and toxin-induced PAH, Connective tissue disease--associated PAH (CTD-PAH), HIV-associated PAH, or Corrected congenital heart disease PAH

6)WHO Functional Class II or III at baseline

7)6-minute walk distance >=50 meters

8)Ability to provide informed consent and comply with study procedures.



TRITON EXCLUSION CRITERIA:

1)Prior PAH therapy of any kind (ERA, PDE5i, prostacyclin, selexipag, riociguat, inhaled treprostinil, etc.).

2)PH Groups 2--5, including: Left-heart disease, Significant lung disease (COPD, ILD, severe parenchymal abnormalities), Chronic thromboembolic PH, or Multifactorial/mechanism-unclear PH

3)Severe lung disease, including: DLCO <40% predicted, Moderate-severe interstitial lung disease, or Significant obstructive disease

4)Severe hepatic impairment (Child-Pugh C)

5)Severe renal impairment (CrCl <30 mL/min)

6)Hemodynamic instability at baseline (e.g., systemic hypotension)

7)Pregnancy or breastfeeding

8) Known hypersensitivity to macitentan, tadalafil, or selexipag

9) Significant comorbidities that could confound PAH evaluation, including: Uncontrolled thyroid disease, Uncontrolled anemia, Active infection, Significant coronary artery disease

10)Recent cardiovascular events, including: MI or stroke within 6 months or Unstable arrhythmias

11)Life expectancy <1 year for non-PAH reasons.

12)Participation in another investigational drug trial within 30 days.

"
  ["project_main_outcome_measure"]=>
  string(680) "Primary hemodynamic outcomes:

1)Baseline, 12-week, and 26-week PAC (and change in PAC)

2)Baseline, 12-week, and 26-week RC time (and change in RC time)

3)Baseline, 12-week, and 26-week SVI (and change in SVI)



Secondary/linked outcomes:

1)Changes in mPAP, CO, and SV, and PVR to compare with exploration variables

2)Proportion of "responders" achieving a prespecified low-risk PAC, SVI, and RC-time threshold with dual vs triple therapy

3)Relationship between change in PAC/RC time/SVI and change in 6MWD and WHO functional class

4)Relationship between change in PAC/RC time/SVI and time to clinical worsening

"
  ["project_main_predictor_indep"]=>
  string(1639) "The main independent variable is treatment assignment in TRITON which is either dual therapy[macitentan+tadalafil] vs triple therapy[macitentan+tadalafil+selexipag]



The variables to be studied include: systolic pulmonary arterial pressure[ sPAP], diastolic pulmonary arterial pressure [ dPAP], mean pulmonary arterial pressure[ mPAP], pulmonary artery wedge pressure [PAWP], RA pressure [RAP], Cardiac output [CO], Cardiac index[ CI] and Heart Rate[ HR] which will be used to derive the following:



1) Pulmonary Arterial Compliance (PAC): Measure of the ability of the pulmonary arteries to expand with each heartbeat

Formula: PAC = SV / (sPAP - dPAP)

Units: 

SV: mL/beat

Pressure: mmHg

PAC: mL/mmHg



2. Resistance-Compliance Time Constant (RC Time): Time constant that describes how quickly pressure decays in the pulmonary circulation and reflecting the combined effects of vascular resistance and stiffness

Formula: RC time = PVR x PAC

Units: seconds



Pulmonary Vascular Resistance (PVR): Calculated resistance to blood flow through the pulmonary circulation

Formula: PVR = (mPAP -- PAWP) / CO

Units:

Pressure in mmHg

CO in L/min

PVR: Wood units (WU) = mmHg.min/L



3. Stroke Volume Index (SVI): Stroke volume normalized to body surface area

Formula: SVI = SV / BSA

Units: mL/beat/m^2



Stroke Volume (SV): Volume of blood ejected per heartbeat

Formula: SV = CO xHR

Units:

CO in L/min

HR in beats/min

SV: mL/beat

"
  ["project_other_variables_interest"]=>
  string(175) "1)Six minute walk distance in meters

2)WHO Functional Class as ordinal scale I, II, III, IV

3)Time to clinical worsening in days/weeks from randomization

"
  ["project_stat_analysis_plan"]=>
  string(767) "1)Baseline characteristics summarized by treatment group using Mean +/- SD or median for continuous variables and Counts (%) for categorical variables



2)Longitudinal change in PAC, RC time, and SVI will be reported using linear mixed-effects models as estimated mean change from baseline by group at 12 and 26 weeks and between-group differences in change with 95% CIs and p-values.



3)Responder status will be analyzed with logistic regression for responder vs non-responder



4)Change in 6MWD and WHO FC will be reported using linear mixed-effects models



5)Time to clinical worsening from randomization will be evaluated using Cox proportional hazards models with treatment group as primary predictor

"
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      ["label"]=>
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      string(5) "stata"
      ["label"]=>
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  ["project_timeline"]=>
  string(1478) "The timeline is as follows:

Week 0: YODA approval



Data Obtaining(Month 1)

End of Month 1 Secure download of individual participant data (IPD) and clinical study report (CSR) and dataset structure fully reviewed.



Data Cleaning & Derivation (Month 1--2)

Cleaning of hemodynamics, demographics, biomarkers, and outcomes and Derivation of PAC, RC-time, SVI, pulse pressure, stroke volume, and change-from-baseline variables



Primary & Secondary Analyses (Month 2--3)

Statistical results obtained



Interpretation, Figures, and Drafting (Month 3--4)

Interpretation of findings and preparation of tables/figures, Drafting of manuscript introduction, methods, results, and discussion.

End of Month 4: Internal manuscript draft completed



Manuscript Revision & Coauthor Review (Month 4--5)

Coauthor scientific review and edits, final revisions, formatting, and journal targeting.

End of Month 5: Manuscript finalized for submission



Submission & Peer Review (Month 5--6)

Submission to target journal, address early editorial queries if needed.



Return of Results to YODA (Month 6--7)

Month 6: Provide YODA with summary of key findings, analytic code, and manuscript citation (or preprint).



Month 7: Upload final accepted manuscript or revised version if still under peer review.

"
  ["project_dissemination_plan"]=>
  string(549) "The dissemination plan includes:

1)Peer-Reviewed publication by preparing a full manuscript summarizing study methods, results, and clinical relevance.

Target high-impact journals in pulmonary vascular and cardiopulmonary medicine include Circulation, ERJ, CHEST, AJRCCM



2)Conference Abstracts: Submit abstracts to major scientific meetings, including ATS or CHEST and present as a poster or oral session



3) Provide YODA with a structured summary of findings and the final or submitted manuscript.

"
  ["project_bibliography"]=>
  string(2271) "

Chin KM, Sitbon O, Doelberg M, et al. Three- Versus Two-Drug Therapy for Patients With Newly Diagnosed Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2021;78(14):1393-1403. doi:10.1016/j.jacc.2021.07.057.
ClinicalTrials.gov. The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension (TRITON). ClinicalTrials.gov Identifier: NCT02558231. Accessed December 21, 2025.
Thenappan T, Prins KW, Pritzker MR, Scandurra J, Volmers K, Weir EK. The Critical Role of Pulmonary Arterial Compliance in Pulmonary Hypertension. Ann Am Thorac Soc. 2016;13(2):276-284. doi:10.1513/AnnalsATS.201509-599FR.
Chemla D, Lau EMT, Papelier Y, Attal P, Hervé P. Pulmonary vascular resistance and compliance relationship in pulmonary hypertension. Eur Respir J. 2015;46(4):1178-1189. doi:10.1183/13993003.00741-2015.
Saouti N, Westerhof N, Helderman F, et al. RC time constant of single lung equals that of both lungs together: a study in chronic thromboembolic pulmonary hypertension. Am J Physiol Heart Circ Physiol. 2009;297(6):H2154-H2160. doi:10.1152/ajpheart.00694.2009.
MacKenzie Ross RV, Toshner MR, Soon E, Naeije R, Pepke-Zaba J. Decreased time constant of the pulmonary circulation in chronic thromboembolic pulmonary hypertension. Am J Physiol Heart Circ Physiol. 2013;305(2):H259-H264. doi:10.1152/ajpheart.00128.2013.
Hadinnapola C, Li J, Su L, et al. The resistance-compliance product of the pulmonary circulation varies in health and pulmonary vascular disease. Physiol Rep. 2015;3(4):e12363. doi:10.14814/phy2.12363.
Metkus TS, Mullin CJ, Grandin EW, et al. Heart Rate Dependence of the Pulmonary Resistance x Compliance (RC) Time and Impact on Right Ventricular Load. PLOS One. 2016;11(11):e0166463. doi:10.1371/journal.pone.0166463.
Manouras A, Lund LH, Nagy AI, Johnson J. Insights into RC time curve fit analysis of pulmonary artery pressure decay. BMC Pulm Med. 2024;24(1):295. doi:10.1186/s12890-024-03107-5.
Naeije R, Delcroix M. Is the time constant of the pulmonary circulation truly constant? Eur Respir J. 2014;43(5):1541-1542. doi:10.1183/09031936.00174213.


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    int(0)
    ["mime_type"]=>
    string(15) "application/pdf"
    ["type"]=>
    string(11) "application"
    ["subtype"]=>
    string(3) "pdf"
    ["icon"]=>
    string(62) "https://yoda.yale.edu/wp/wp-includes/images/media/document.png"
  }
  ["project_highlight_button"]=>
  string(0) ""
  ["request_overridden_res"]=>
  string(1) "3"
  ["request_data_partner"]=>
  string(15) "johnson-johnson"
}
data partner
array(1) {
  [0]=>
  string(15) "johnson-johnson"
}


pi country
array(0) {
}


pi affil
array(0) {
}


products
array(1) {
  [0]=>
  string(7) "uptravi"
}


num of trials
array(1) {
  [0]=>
  string(1) "1"
}


res
array(1) {
  [0]=>
  string(1) "3"
}