- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00477724
Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy
Severe CTEPH leads to an impaired physical capacity and a restricted quality of life and poor prognosis.
Pulmonary endarterectomy represents the best choice as therapy, when the thrombi are located in the central pulmonary vessels and therefore can be operated. By this operation the pulmonary artery pressure can be normalised and the patients' survival improved. Up to now, after successful endarterectomy patients only receive anticoagulation.
Despite operation many patients remain symptomatic and are restricted in their physical capacity. Therefore a hypothesis of this project is that most of the patients, even after successful operation, show peripheral vascular remodelling with a ventilation-perfusion mismatch and elevated pulmonary pressure during exercise.
In this study we aim to analyse how many patients with CTEPH after endarterectomy show elevated pulmonary artery pressures at rest or during exercise and are limited in their physical capacity, hemodynamics, oxygen uptake and quality of life and need further therapy.
Another aim is to examine whether exercise and respiratory therapy may improve the patients postoperatively.
Therefore 30 patients with CTEPH > six months after endarterectomy, with ongoing restricted exercise capacity shall be included. After baseline examination in the University hospital Heidelberg the patients receive exercise and respiratory therapy for three weeks. The patients will receive further examinations at the end of rehabilitation after 3 weeks and after 15 weeks. All examinations include medical history, family history, physical examination, ECG and echocardiography at rest and during exercise, cardiopulmonary exercise testing, assessment of the respiratory muscle strength, the SF-36 questionnaire for quality of life, laboratory testing and MRI.
Rehabilitation will be conducted in the clinic for rehabilitation Koenigstuhl, Heidelberg. Participants will be randomised into two groups, a control group receiving a conventional therapy for three weeks, in which physical exertion is to be avoided and a training group with additional exercise and respiratory therapy.
연구 개요
상태
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ekkehard Gruenig, MD
- 전화번호: +49 6221 396 80 53
- 이메일: ekkehard.gruenig@med.uni-heidelberg.de
연구 장소
-
-
Baden-Wuerttemberg
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Heidelberg, Baden-Wuerttemberg, 독일, 69120
- 모병
- Thoraxclinic at the University Hospital Heidelberg
-
수석 연구원:
- Ekkehard Gruenig, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
A Screening
- Informed consent
- Men and women 18 - 75 years
- Patients ≥ 6 months after endarterectomy because of chronic thromboembolic pulmonary hypertension (CTEPH)
- B Training
See A + all patients who showed a restricted physical capacity in the screening:
- Latent pulmonary hypertension
- Restricted physical capacity
Exclusion Criteria:
- Pregnancy or lactation
- Change in medication during the last 2 months
- Patients with signs of right heart decompensation
- Disease which affects the gait
- Unclear diagnosis
- Acute illness, infection, fever
- Severe lung diseases with FEV1 <50% and TLC< 70% of reference
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: sedentary control group
patients are treated by conventional rehabilitation
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control group with no specific training
|
|
활성 비교기: exercise and respiratory therapy
rehabilitation with exercise and respiratory therapy
|
exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in 6-Minute walking test
기간: after 3 and 15 weeks compared to baseline
|
after 3 and 15 weeks compared to baseline
|
|
Change in quality of life
기간: baseline and 15 weeks
|
baseline and 15 weeks
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
physical capacity in the ergometer test
기간: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of lung function during 6-minute walking test
기간: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
noninvasive hemodynamic parameters
기간: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of systolic pulmonary arterial pressure at rest and during exercise
기간: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of WHO functional class
기간: baseline, 3 and 15 weeks
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baseline, 3 and 15 weeks
|
|
change of perfusion parameters (MRI)
기간: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
|
change of respiratory muscle function
기간: baseline and 15 weeks
|
baseline and 15 weeks
|
|
change of NTproBNP
기간: baseline, 3 and 15 weeks
|
baseline, 3 and 15 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .