Acute Cardiac Effects of Ultra-Trail Running (ULTRA-ECHO)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Nathalie Pace, MD
- 전화번호: +33383157352
- 이메일: n.pace@chru-nancy.fr
연구 연락처 백업
- 이름: Ninon Mougel, MD
- 이메일: n.mougel@chru-nancy.fr
연구 장소
-
-
Meurthe-et-Moselle
-
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 프랑스, 54511
- Centre Hospitalier Régional Universitaire de Nancy
-
연락하다:
- Nathalie Pace, MD
- 전화번호: +33383157352
- 이메일: n.pace@chru-nancy.fr
-
연락하다:
- Ninon Mougel, MD
- 이메일: n.mougel@chru-nancy.fr
-
수석 연구원:
- Nathalie Pace, MD
-
부수사관:
- Ninon Mougel, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Left Ventricular Global Longitudinal Strain (GLS)
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Structural echocardiographic parameters, ventricular volumes, and myocardial strain
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nathalie Pace, MD, CHRU de Nancy
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2025-A02579-40
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .