{"id":5183,"date":"2026-09-24T11:55:00","date_gmt":"2026-09-24T09:55:00","guid":{"rendered":"https:\/\/www.phinc-group.com\/?p=5183"},"modified":"2026-09-24T12:47:04","modified_gmt":"2026-09-24T10:47:04","slug":"reduction-du-risque-de-toxicite-cardiaque","status":"publish","type":"post","link":"https:\/\/www.phinc-group.com\/en\/reduction-du-risque-de-toxicite-cardiaque\/","title":{"rendered":"De-risking cardiac toxicity:\nThe Evolution of QT\/QTc Assessment in Drug Development"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"5183\" class=\"elementor elementor-5183\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-778ab1f e-con-full e-flex e-con e-parent\" data-id=\"778ab1f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b77e2ec elementor-widget elementor-widget-html\" data-id=\"b77e2ec\" data-element_type=\"widget\" data-e-type=\"widget\" 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28px 56px}\r\n}\r\n<\/style>\r\n\r\n<div class=\"midd-page\">\r\n\r\n  <!-- ================= HERO ================= -->\r\n  <header class=\"midd-hero\">\r\n    <div class=\"midd-wrap midd-hero-grid\">\r\n      <div>\r\n        <span class=\"midd-eyebrow\"><span class=\"dot\"><\/span>CARDIAC SAFETY<\/span>\r\n        <h1>De-risking <em>cardiac toxicity<\/em><\/h1>\r\n        <p class=\"midd-sub\">The Evolution of QT\/QTc Assessment in Drug Development<\/p>\r\n        <div class=\"midd-pills\">\r\n          <span class=\"midd-pill\">ICH E14<\/span>\r\n          <span class=\"midd-pill\">Canal hERG<\/span>\r\n          <span class=\"midd-pill\">CiPA<\/span>\r\n          <span class=\"midd-pill\">C-QTc Modeling<\/span>\r\n        <\/div>\r\n      <\/div>\r\n      <div class=\"midd-img tall\" role=\"img\" aria-label=\"Illustration : suivi du rythme cardiaque sur montre connect\u00e9e\" style=\"background-image:url('https:\/\/www.phinc-group.com\/wp-content\/uploads\/2026\/09\/Cardiac-safety-hero-image-4-3.png');\"><\/div>\r\n    <\/div>\r\n  <\/header>\r\n\r\n  <!-- ================= INTRO ================= -->\r\n  <section class=\"midd-section\" style=\"padding-top:0\">\r\n    <div class=\"midd-wrap midd-narrow\">\r\n      <p>Historically, discovering a novel therapeutic was often compromised by an unforeseen, late-stage hurdle: drug-induced cardiac toxicity. The unintended delay of ventricular repolarization, measured as QT interval prolongation, has been a leading cause of drug withdrawal due to its association with Torsades de Pointes (TdP), a potentially fatal polymorphic ventricular arrhythmia. (Nachimuthu et al., 2012).<\/p>\r\n      <div class=\"midd-quote\">\r\n        <p>It is no longer a late-phase bottleneck but a predictive, engineered science.<\/p>\r\n      <\/div>\r\n      <p>Proactive cardiac safety evaluation keeps otherwise efficacious drugs in the pipeline by identifying and mitigating risks early.<\/p>\r\n    <\/div>\r\n    <div class=\"midd-wrap\" style=\"margin-top:40px\">\r\n      <div class=\"midd-img banner\" role=\"img\" aria-label=\"Analyse ECG en laboratoire\" style=\"background-image:url('https:\/\/www.phinc-group.com\/wp-content\/uploads\/2026\/09\/phinc-labo-ecg-analysis-21-7.png');\"><\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <hr class=\"midd-divider\">\r\n\r\n  <!-- ================= 1. R\u00c9GLEMENTAIRE ================= -->\r\n  <section class=\"midd-section\">\r\n    <div class=\"midd-wrap midd-narrow\">\r\n      <span class=\"midd-kicker\">01. The Regulatory Paradigm Shift<\/span>\r\n      <h2>The global <em>regulatory<\/em><\/h2>\r\n      <div class=\"midd-compare\">\r\n        <div class=\"midd-compare-card\">\r\n          <p class=\"translation-block\">For years, the evaluation of QT prolongation was heavily guided by the <strong>ICH E14<\/strong> regulatory framework, which formally standardized how sponsors evaluate the proarrhythmic potential of non-antiarrhythmic therapies. This milestone regulation introduced the requirement to systematically assess a drug's potential to delay cardiac repolarization through clinical studies (Shah, 2005).<\/p>\r\n        <\/div>\r\n        <div class=\"midd-compare-card pink\">\r\n          <p class=\"translation-block\">The traditional <strong>\"Thorough QT\" (TQT)<\/strong> study typically requires healthy volunteers to receive therapeutic and supra-therapeutic doses of the drug to strictly measure its impact on the QT interval. While highly sensitive, the traditional TQT study is resource-intensive and often flags compounds that prolong the QT interval but do not actually induce fatal arrhythmias.<\/p>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <hr class=\"midd-divider\">\r\n\r\n  <!-- ================= 2. M\u00c9CANISTE ================= -->\r\n  <section class=\"midd-section\">\r\n    <div class=\"midd-wrap\">\r\n      <div class=\"midd-narrow\">\r\n        <span class=\"midd-kicker\">02 \u00b7 Mechanisms<\/span>\r\n        <h2>Mechanistic understanding: <em>hERG and beyond<\/em><\/h2>\r\n        <p>At the cellular level, acquired long QT syndrome is primarily driven by the unintended blockade of the rapid delayed rectifier potassium channel, known as the hERG channel.<\/p>\r\n      <\/div>\r\n      <div class=\"midd-cards\">\r\n        <div class=\"midd-card\">\r\n          <div class=\"midd-chip\"><svg viewbox=\"0 0 24 24\"><path d=\"M3 12h4l2-5 4 10 2-5h6\"\/><\/svg><\/div>\r\n          <p>When a drug inhibits the inward potassium rectifier current, it increases the action potential duration, raising the risk of prolonged QT intervals and TdP (Nachimuthu et al., 2012).<\/p>\r\n        <\/div>\r\n        <div class=\"midd-card\">\r\n          <div class=\"midd-chip\"><svg viewbox=\"0 0 24 24\"><circle cx=\"6\" cy=\"12\" r=\"2.5\"\/><circle cx=\"18\" cy=\"6\" r=\"2.5\"\/><circle cx=\"18\" cy=\"18\" r=\"2.5\"\/><path d=\"M8.3 11l7.4-3.8M8.3 13l7.4 3.8\"\/><\/svg><\/div>\r\n          <p>However, evaluating the hERG channel in isolation can be misleading, as some drugs possess multichannel effects.<\/p>\r\n        <\/div>\r\n        <div class=\"midd-card\">\r\n          <div class=\"midd-chip\"><svg viewbox=\"0 0 24 24\"><path d=\"M7 3c0 6 10 6 10 12s-10 6-10 6M17 3c0 6-10 6-10 12\"\/><path d=\"M9 7h6M9 17h6\"\/><\/svg><\/div>\r\n          <p>Furthermore, a mutation in genes encoding protein channels or poor metabolism of drugs due to CYP2D6 enzyme polymorphisms can elevate a patient's susceptibility to TdP upon drug exposure.<\/p>\r\n        <\/div>\r\n      <\/div>\r\n      <div class=\"midd-narrow\">\r\n        <p class=\"translation-block\">To address limitations in traditional assessments, the field has advanced toward newer initiatives like the Comprehensive in vitro Proarrhythmia Assay (CiPA), moving away from relying purely on isolated hERG blockade and QTc prolongation as absolute surrogates for TdP risk.<\/p>\r\n      <\/div>\r\n      <div class=\"midd-space\"><\/div>\r\n      <div class=\"midd-img\" role=\"img\" aria-label=\"Canal hERG et risque cardiaque\" style=\"background-image:url('https:\/\/www.phinc-group.com\/wp-content\/uploads\/2026\/09\/canal-herg-heart-attack-16-7.png');\"><\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <hr class=\"midd-divider\">\r\n\r\n  <!-- ================= 3. CAS D'USAGE ================= -->\r\n  <section class=\"midd-section\">\r\n    <div class=\"midd-wrap midd-narrow\">\r\n      <span class=\"midd-kicker\">03 \u00b7 Clinical programs<\/span>\r\n      <h2 class=\"translation-block\">High-Impact use cases in <em>clinical programs <\/em><\/h2>\r\n      <p>Similar to the integration of Model-Informed Drug Development (MIDD) methodologies used to define dosing and efficacy in oncology, the optimization of cardiac safety relies on rigorous quantitative frameworks.<\/p>\r\n      <div class=\"midd-compare\">\r\n        <div class=\"midd-compare-card\">\r\n          <p class=\"translation-block\"><strong>Concentration-Response Modeling:<\/strong><br> Instead of relying exclusively on time-point electrocardiogram (ECG) analysis, modern protocols use concentration-QTc (C-QTc) modeling. This maps the exact relationship between drug exposure (pharmacokinetics) and QT prolongation (pharmacodynamics), often waiving the need for a standalone TQT study if early-phase FIH (First-in-Human) data is robust.<\/p>\r\n        <\/div>\r\n        <div class=\"midd-compare-card pink\">\r\n          <p><strong>Identifying At-Risk Subpopulations:<\/strong> Because certain patients possess a genetic predisposition to prolonged QT, modeling must account for these intrinsic vulnerabilities to prevent unexpected toxicity in clinical practice (Nachimuthu et al., 2012).<\/p>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n    <div class=\"midd-wrap\" style=\"margin-top:16px\">\r\n      <div class=\"midd-img\" role=\"img\" aria-label=\"Mod\u00e9lisation concentration-QTc\" style=\"background-image:url('https:\/\/www.phinc-group.com\/wp-content\/uploads\/2026\/09\/QTc-Analysis-Modeling.png');\"><\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <hr class=\"midd-divider\">\r\n\r\n  <!-- ================= 4. BONNES PRATIQUES ================= -->\r\n  <section class=\"midd-section\">\r\n    <div class=\"midd-wrap\">\r\n      <div class=\"midd-narrow\">\r\n        <span class=\"midd-kicker\">04 \u00b7 Recommandations<\/span>\r\n        <h2 class=\"translation-block\">Best practices<em> for sponsors<\/em><\/h2>\r\n        <p>To successfully navigate cardiac safety expectations, drug developers should adopt the following strategies:<\/p>\r\n      <\/div>\r\n      <div class=\"midd-cards\">\r\n        <div class=\"midd-card\">\r\n          <div class=\"midd-chip\"><svg viewbox=\"0 0 24 24\"><path d=\"M9 3h6M10 3v6l-5 9a2 2 0 0 0 2 3h10a2 2 0 0 0 2-3l-5-9V3\"\/><path d=\"M7.5 14h9\"\/><\/svg><\/div>\r\n          <h3 class=\"translation-block\">Integrate early <em>in vitro<\/em> and <em>in silico<\/em> data:<\/h3>\r\n          <p class=\"translation-block\">Do not wait for Phase II or III to discover a proarrhythmic liability. Utilize multi-ion channel patch-clamp assays and <em>in silico<\/em> human action potential reconstructions during preclinical stages.<\/p>\r\n          <div class=\"midd-tags\"><span class=\"midd-tag\">Preclinical<\/span><span class=\"midd-tag\">Patch-clamp<\/span><\/div>\r\n        <\/div>\r\n        <div class=\"midd-card\">\r\n          <div class=\"midd-chip\"><svg viewbox=\"0 0 24 24\"><rect x=\"3\" y=\"4\" width=\"18\" height=\"14\" rx=\"2\"\/><path d=\"M5 12h3l1.5-3 2.5 6 1.5-3H19\"\/><path d=\"M8 21h8\"\/><\/svg><\/div>\r\n          <h3>Leverage Phase I Intensive ECG Monitoring:<\/h3>\r\n          <p>Embed high-quality, continuous ECG extraction in single and multiple ascending dose studies. Robust early data coupled with concentration-response modeling can satisfy regulatory requirements much earlier in the development lifecycle.<\/p>\r\n          <div class=\"midd-tags\"><span class=\"midd-tag\">Phase I<\/span><span class=\"midd-tag\">C-QTc<\/span><\/div>\r\n        <\/div>\r\n        <div class=\"midd-card\">\r\n          <div class=\"midd-chip\"><svg viewbox=\"0 0 24 24\"><rect x=\"3\" y=\"9\" width=\"10\" height=\"6\" rx=\"3\" transform=\"rotate(-35 8 12)\"\/><rect x=\"11\" y=\"9\" width=\"10\" height=\"6\" rx=\"3\" transform=\"rotate(35 16 12)\"\/><\/svg><\/div>\r\n          <h3>Evaluate Drug-Drug Interactions (DDIs):<\/h3>\r\n          <p>Patients frequently face polypharmacy. Sponsors must rigorously evaluate how concomitant therapies alter the pharmacokinetics of their drug. Just as modeling interactions are vital to preserving oncology trial adherence and mitigating real-world risks, identifying dangerous cardiovascular DDIs ensures patient safety in standard practice.<\/p>\r\n          <div class=\"midd-tags\"><span class=\"midd-tag\">Polypharmacie<\/span><span class=\"midd-tag\">PK<\/span><\/div>\r\n        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <hr class=\"midd-divider\">\r\n\r\n  <!-- ================= CONCLUSION ================= -->\r\n  <section class=\"midd-section\">\r\n    <div class=\"midd-wrap midd-narrow\">\r\n     \r\n      <p>As therapeutic modalities grow more complex, ensuring cardiovascular safety remains an uncompromising priority. By moving beyond simple hERG block assays and traditional resource-heavy approaches, sponsors can implement more precise, mechanism-based predictions of proarrhythmic risk.<\/p>\r\n      <div class=\"midd-quote\">\r\n        <p>Embracing integrated C-QTc modeling and proactive preclinical assays transform cardiac safety from an unpredictable hurdle into a streamlined, scientific asset.<\/p>\r\n      <\/div>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <hr class=\"midd-divider\">\r\n\r\n  <!-- ================= R\u00c9F\u00c9RENCES ================= -->\r\n  <section class=\"midd-section midd-refs\">\r\n    <div class=\"midd-wrap midd-narrow\">\r\n      <span class=\"midd-kicker\">Sources<\/span>\r\n      <h2><em>References<\/em><\/h2>\r\n      <p>Nachimuthu, S., Assar, M. D., &amp; Schussler, J. M. (2012). Drug-induced QT interval prolongation: mechanisms and clinical management. <em>Therapeutic Advances in Drug Safety<\/em>, 3, 241\u2013253. <a href=\"https:\/\/doi.org\/10.1177\/2042098612454283\" target=\"_blank\" rel=\"noopener\">https:\/\/doi.org\/10.1177\/2042098612454283<\/a><\/p>\r\n      <p>Shah, R. R. (2005). Drugs, QTc Interval Prolongation and Final ICH E14 Guideline. <em>Drug Safety<\/em>, 28, 1009\u20131028. <a href=\"https:\/\/doi.org\/10.2165\/00002018-200528110-00003\" target=\"_blank\" rel=\"noopener\">https:\/\/doi.org\/10.2165\/00002018-200528110-00003<\/a><\/p>\r\n    <\/div>\r\n  <\/section>\r\n\r\n  <!-- ================= CTA ================= -->\r\n  <div class=\"midd-wrap\">\r\n    <div class=\"midd-cta\">\r\n      <h2 class=\"translation-block\">Secure your program <em>from the earliest phases<\/em><\/h2>\r\n      <p>Our pharmacometrics and MIDD experts support you in assessing cardiac risk, from C-QTc modeling to regulatory strategy.<\/p>\r\n      <div class=\"midd-btns\">\r\n        <a class=\"midd-btn primary\" href=\"\/en\/contact\/\">Contact our experts<\/a>\r\n        <a class=\"midd-btn ghost\" href=\"\/en\/midd\/\">Discover MIDD strategy<\/a>\r\n      <\/div>\r\n    <\/div>\r\n  <\/div>\r\n\r\n<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>La d\u00e9couverte d&rsquo;un nouveau traitement \u00e9tait souvent compromise par un obstacle impr\u00e9vu et tardif : la toxicit\u00e9 cardiaque induite par les m\u00e9dicaments. Le retard involontaire de la repolarisation ventriculaire, mesur\u00e9 par l&rsquo;allongement de l&rsquo;intervalle QT, a \u00e9t\u00e9 l&rsquo;une des principales causes de retrait de m\u00e9dicaments.<\/p>","protected":false},"author":2,"featured_media":5179,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39,37],"tags":[],"service-associe":[],"class_list":["post-5183","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-a-la-une","category-blog"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>R\u00e9duction du risque de toxicit\u00e9 cardiaque : L&#039;\u00e9volution de l&#039;\u00e9valuation de l&#039;intervalle QT\/QTc dans le d\u00e9veloppement de m\u00e9dicaments - PhinC Group<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.phinc-group.com\/en\/reduction-du-risque-de-toxicite-cardiaque\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"R\u00e9duction du risque de toxicit\u00e9 cardiaque : L&#039;\u00e9volution de l&#039;\u00e9valuation de l&#039;intervalle QT\/QTc dans le d\u00e9veloppement de m\u00e9dicaments - PhinC Group\" \/>\n<meta property=\"og:description\" content=\"La d\u00e9couverte d&#039;un nouveau traitement \u00e9tait souvent compromise par un obstacle impr\u00e9vu et tardif : la toxicit\u00e9 cardiaque induite par les m\u00e9dicaments. 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