Right Heart International NETwork During Exercise in Different Clinical Conditions (RIGHT-Net)
Morphological and Functional Response of the Right Heart and Pulmonary Circulation
The aim of this registry will be to compare the pathophysiological response of the morphology and function of the right heart and pulmonary circulation assessed with resting and stress-echocardiography in patients with various cardiovascular diseases, to compare them to healthy individuals. The physiological response in healthy individuals as well as elite athletes, defined as athletes participating at national and international competitions, will also be evaluated. Patients will be enrolled both prospectively as well as retrospectively and the will be evaluated by resting and stress echocardiography, which are part of the routine clinical practice.
All clinical outcome measures will be collected as part of routine examinations. The measurements will include systolic and diastolic pump function of the right and left ventricles and other echocardiographic parameters. Moreover, a comparison of these parameters among different groups will be performed. Other optional assessments will include: exercise capacity assessed with 6-minute walking distance, World Health Organization functional class (WHO functional class), peak oxygen uptake assessed by spiroergometry. Patients will be evaluated at baseline and each year with the aforementioned procedures according to the sites clinical routine.
연구 개요
상세 설명
Patients will be evaluated with a routinely performed resting and stress echocardiography. Moreover, physical examination and ECG will be performed and past medical history will be collected. Optional procedures comprise of quality of life assessment (SF-36 questionnaire), six minute walking distance (6MWD), cardiopulmonary exercise testing (CPET), routine laboratory including biochemical work-up.
Comparison among different cohorts of patients with regards to right heart morphology and function at rest, assessed during a routinely performed resting and stress echography. The following parameters will be evaluated:
- Right ventricular (RV) diameters
- RV free wall thickness
- End-diastolic and end-systolic left ventricular volumes and ejection fraction
- Right atrial (RA) area
- End-diastolic and end-systolic RV area and % shortening of the areas of the right ventricle
- Tricuspid regurgitation velocity (TRV) and severity
- Tricuspid annular plane systolic excursion (TAPSE)
- Inferior vena cava diameter and % of collapsibility
- TAPSE at peak exercise and after 5 minutes recovery
- TRV at peak exercise and after 5 minutes recovery
- RV end-diastolic and end-systolic area and % shortening of the areas at peak exercise and after 5 minutes recovery
- RA area at peak exercise and after 5 minutes recovery
- Left ventricular end-diastolic and end-systolic volume and ejection fraction at peak exercise and after 5 minutes recovery
- Left ventricular eccentricity index at peak exercise and after 5 minutes recovery
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Eduardo Bossone, Chief of Cardiology
- 전화번호: +390899926241
- 이메일: ebossone@hotmail.com
연구 연락처 백업
- 이름: Alberto M. Marra, MD
- 전화번호: +4915207559254
- 이메일: alberto.marra@med.uni-heidelberg.de
연구 장소
-
-
Salerno
-
Cava de' Tirreni, Salerno, 이탈리아, 84019
- 모병
- Cardiology and Coronary Care Unit
-
연락하다:
- Eduardo Bossone
- 전화번호: +390899926241
- 이메일: ebossone@hotmail.com
-
연락하다:
- Francesco Ferrara
- 전화번호: +393386762554
- 이메일: francesco.ferrara30@tin.it
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Written informed consent
- Males and females ≥ 18 years' old
- Ability to understand study-specific design and procedures and provide informed consent to the study
Exclusion Criteria:
- Inability to perform exercise stress test
- Active smoker
- Pregnancy and/or lactation
- Active malignancy
- End-stage renal disease requiring dialysis
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
Healthy subjects
Cohort of patients referred to our echocardiography laboratory to work assessment procedures and without any cardiovascular risk factor.
They will underwent stress echocardiography.
|
stress echocardiography will be performed in accordance with the current guidelines on a variable load 45° cycle ergometer with an incremental workload of 25 W every 2 minutes up to the symptom-limited maximal tolerated workload. Echocardiographic measurements will be acquired at baseline, at peak exercise and during recovery of 5 minutes. The electrocardiogram and blood pressure will be monitored at each workload. Termination criteria and / or positive test criteria for inducible myocardial ischemia will follow the current recommendations |
|
cardio-respiratory diseases
patients with any possible cardiovascular and respiratory condition.
They will underwent stress echocardiography.
|
stress echocardiography will be performed in accordance with the current guidelines on a variable load 45° cycle ergometer with an incremental workload of 25 W every 2 minutes up to the symptom-limited maximal tolerated workload. Echocardiographic measurements will be acquired at baseline, at peak exercise and during recovery of 5 minutes. The electrocardiogram and blood pressure will be monitored at each workload. Termination criteria and / or positive test criteria for inducible myocardial ischemia will follow the current recommendations |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Right Ventricle contractile reserve
기간: ten years
|
Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)
|
ten years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
All-cause Mortality
기간: ten years
|
All cause of mortality
|
ten years
|
|
Cardiovascular Mortality
기간: ten years
|
all cardiovascular mortality
|
ten years
|
|
RV internal end-diastolic diameters
기간: ten years
|
measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm
|
ten years
|
|
tricuspid annular plane systolic excursion (TAPSE)
기간: ten years
|
tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm
|
ten years
|
공동 작업자 및 조사자
수사관
- 연구 의자: Eduardo Bossone, Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RIGHT-Net
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
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