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Acute Cardiac Effects of Ultra-Trail Running (ULTRA-ECHO)

2026年8月4日 更新者:PACE Nathalie、Central Hospital, Nancy, France

Echocardiographic Assessment of the Acute Impact of an Ultra-Trail Race on Cardiac Function

This prospective observational study aims to investigate the acute cardiovascular effects of ultra-endurance running using comprehensive echocardiographic assessment combined with biological analyses. The main hypothesis is that participation in an ultra-trail race induces acute and transient changes in cardiac function involving both the left and right ventricles, associated with elevations in cardiac biomarkers, with physiological responses varying according to race distance and training level and showing spontaneous recovery within the days following the event.

Adult amateur runners participating in ultra-trail races of 80 km or 160 km will undergo standardized clinical evaluation, electrocardiography, and transthoracic echocardiography with myocardial deformation analysis at multiple time points, including baseline, pre-effort, during the race, immediately after exercise, and during early recovery approximately one week after the event. Biological sampling will be performed before the race, immediately after exercise, and at follow-up.

The primary objective is to evaluate acute changes in left ventricular systolic function assessed by global longitudinal strain. Secondary objectives include the assessment of biventricular and atrial function, cardiac and non-cardiac biomarkers, recovery patterns after ultra-endurance exercise, and the influence of race distance, training level, performance level, and sex on cardiovascular responses.

This exploratory single-center study conducted in France seeks to provide an integrative characterization of cardiac adaptations to extreme endurance exercise and to generate physiological insights that may guide future research and cardiovascular monitoring strategies in endurance athletes.

調査の概要

状態

まだ募集していません

詳細な説明

Ultra-endurance running has gained increasing popularity, yet its acute cardiovascular effects remain incompletely characterized. Previous studies in endurance athletes have reported transient changes in myocardial function and elevations in cardiac biomarkers after prolonged exercise, but available data in ultra-trail settings remain limited and heterogeneous. Most prior investigations relied on pre- and post-race comparisons, small sample sizes, or incomplete assessment of right ventricular and atrial function, and rarely integrated multimodal echocardiographic imaging with standardized biological analyses.

The ULTRA-ECHO study is a prospective observational physiology study designed to investigate acute and short-term cardiovascular adaptations to ultra-endurance exercise under real-life conditions. Adult runners participating in the "Trail des Échos" ultra-trail race (80 km or 160 km) will undergo standardized transthoracic echocardiography, clinical evaluation, and biological sampling at predefined time points, including baseline screening, pre-effort, during the race, immediately after exercise, and during early recovery approximately one week after the event. Echocardiographic acquisitions will be performed using standardized imaging protocols on identical ultrasound systems, with centralized offline analysis and blinded secondary review in order to ensure reproducibility and minimize operator-related bias.

The primary focus of the study is the assessment of left ventricular global longitudinal strain (GLS), a sensitive marker of subclinical systolic myocardial function that may detect exercise-induced myocardial fatigue even when conventional ejection fraction remains preserved. Secondary evaluations include comprehensive structural and functional echocardiographic parameters of the left ventricle, right ventricle, and left atrium, as well as cardiac and systemic biological responses to prolonged endurance exercise.

This exploratory before-after design does not include a control group, as each participant serves as their own control through repeated within-subject assessments. The study also aims to explore potential modifiers of cardiovascular responses, including race distance, finisher status, training level, performance level, and sex. By integrating sequential imaging, biomarker analysis, and early follow-up evaluation, ULTRA-ECHO seeks to improve understanding of transient cardiac adaptations and recovery dynamics associated with ultra-endurance exercise and to generate physiological insights that may inform future research and cardiovascular monitoring strategies in endurance athletes.

研究の種類

観察的

入学 (推定)

60

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy、Meurthe-et-Moselle、フランス、54511
        • Centre Hospitalier Régional Universitaire de Nancy
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Nathalie Pace, MD
        • 副調査官:
          • Ninon Mougel, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

Adult ultra-endurance runners participating in the "Trail des Échos" ultra-trail race (80 km or 160 km), screened prior to participation and recruited to investigate physiological cardiovascular adaptations to prolonged endurance exercise in individuals without known cardiovascular disease.

説明

Inclusion Criteria:

  • Adults aged ≥18 years
  • Registered participants in the "Trail des Échos" ultra-trail race (80 km or 160 km)
  • Valid health clearance according to French Athletics Federation requirements
  • Affiliation with a national health insurance system
  • Able to understand study procedures and provide written informed consent

Exclusion Criteria:

  • Known or suspected cardiovascular disease at screening, including coronary artery disease, heart failure, clinically significant arrhythmias, moderate-to-severe valvular disease, uncontrolled hypertension, or prior stroke
  • Acute infection or unstable chronic medical condition (e.g., uncontrolled diabetes, renal, hepatic, respiratory, thyroid, or inflammatory disease)
  • Current treatments that may interfere with cardiovascular or biological assessments (including renin-angiotensin-aldosterone system blockers, chronic diuretics, anticoagulants, or systemic corticosteroids)
  • Use of systemic non-steroidal anti-inflammatory drugs within 3 days before the race or planned during the event
  • Participation in another ultra-endurance race (≥80 km) within 7 days before or after the study race
  • Pregnancy or breastfeeding
  • Inability to provide informed consent or legal protection status
  • Participation in another interventional clinical study

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
Ultra-Endurance Runners
Adult amateur runners participating in ultra-trail races (80 km or 160 km) undergoing prospective echocardiographic and biological assessments to evaluate acute cardiovascular adaptations to ultra-endurance exercise.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Left Ventricular Global Longitudinal Strain (GLS)
時間枠:Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Left ventricular global longitudinal strain measured by transthoracic echocardiography using speckle-tracking analysis. Image acquisition is standardized and analyzed centrally with blinded secondary review to assess subclinical systolic myocardial function in ultra-endurance runners.
Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)

二次結果の測定

結果測定
メジャーの説明
時間枠
Structural echocardiographic parameters, ventricular volumes, and myocardial strain
時間枠:Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Assessment of left and right ventricular sizes and volumes (millimeters or milliliters), left atrial dimensions (millimeters or milliliters per square meter) and function, alongside right ventricular free-wall strain (percentage), measured by standardized transthoracic echocardiography
Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Echocardiographic assessment of systolic and diastolic function
時間枠:Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Assessment of left and right ventricular systolic and diastolic function, including FAC (percentage), TAPSE (millimeters), and S' wave (centimeters per second), measured by standardized transthoracic echocardiography
Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Echocardiographic assessment of pulmonary pressures
時間枠:Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Assessment of pulmonary pressures (millimeters of mercury) measured by standardized transthoracic echocardiography
Pre-effort (Baseline / Day 0), during effort (Day 1 to 2), and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Serum high-sensitivity troponin levels
時間枠:Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Measurement of serum high-sensitivity troponin levels (nanograms per liter) to evaluate myocardial stress
Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Serum NT-proBNP levels
時間枠:Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Measurement of serum N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (picograms per milliliter) to evaluate cardiac wall stretch
Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Serum creatine kinase levels
時間枠:Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Measurement of serum creatine kinase levels (units per liter) to evaluate skeletal or myocardial muscle damage
Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3)
Number of participants with abnormal non-cardiac biological laboratory findings
時間枠:Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3
Number of participants presenting with laboratory values outside the standard reference ranges for systemic biological responses, including electrolytes, creatinine, complete blood count, and lactate
Pre-effort (Baseline / Day 0) and immediately post-effort (at time of completion, typically Day 1 to Day 3
Cardiovascular recovery assessed by transthoracic echocardiography
時間枠:Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
Evaluation of myocardial structural and functional recovery, specifically tracking changes in right ventricular free-wall strain (percentage), ventricular volumes (milliliters), and diastolic velocities (centimeters per second) between the end of the race and follow-up
Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
Cardiovascular recovery assessed by serum cardiac biomarkers
時間枠:Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)
Evaluation of cardiac biomarker clearance and recovery, specifically tracking changes in high-sensitivity troponin levels (nanograms per liter) and NT-proBNP levels (picograms per milliliter) between the end of the race and follow-up
Immediately post-effort (at time of completion, Day 1 to 3) and at follow-up (6 ± 1 days post-race)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Nathalie Pace, MD、CHRU de Nancy

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年5月1日

一次修了 (推定)

2027年5月1日

研究の完了 (推定)

2027年5月1日

試験登録日

最初に提出

2026年2月22日

QC基準を満たした最初の提出物

2026年8月4日

最初の投稿 (実際)

2026年8月7日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月7日

QC基準を満たした最後の更新が送信されました

2026年8月4日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 2025-A02579-40

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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