Clinical trial NCT00477724: Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy
Official title: Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Keywords: latent
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-05-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* A Screening

  1. Informed consent
  2. Men and women 18 - 75 years
  3. 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:

1. Pregnancy or lactation
2. Change in medication during the last 2 months
3. Patients with signs of right heart decompensation
4. Disease which affects the gait
5. Unclear diagnosis
6. Acute illness, infection, fever
7. Severe lung diseases with FEV1 \<50% and TLC\< 70% of reference

Primary outcomes:
measure: Change in 6-Minute walking test
timeFrame: after 3 and 15 weeks compared to baseline
measure: Change in quality of life
timeFrame: baseline and 15 weeks
Secondary outcomes:
measure: physical capacity in the ergometer test
timeFrame: baseline, 3 and 15 weeks
measure: change of lung function during 6-minute walking test
timeFrame: baseline, 3 and 15 weeks
measure: noninvasive hemodynamic parameters
timeFrame: baseline, 3 and 15 weeks
measure: change of systolic pulmonary arterial pressure at rest and during exercise
timeFrame: baseline, 3 and 15 weeks
measure: change of WHO functional class
timeFrame: baseline, 3 and 15 weeks
measure: change of perfusion parameters (MRI)
timeFrame: baseline, 3 and 15 weeks
measure: change of respiratory muscle function
timeFrame: baseline and 15 weeks
measure: change of NTproBNP
timeFrame: baseline, 3 and 15 weeks
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxclinic at the University Hospital Heidelberg
state: Baden-Wuerttemberg
Study officials:
affiliation: Thoraxclinic at the University Hospital Heidelberg
name: Ekkehard Gruenig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mereles D, Ewert R, Lodziewski S, Borst MM, Benz A, Olschewski H, Grunig E. Effect of inhaled iloprost during off-medication time in patients with pulmonary arterial hypertension. Respiration. 2007;74(5):498-502. doi: 10.1159/000101953. Epub 2007 Apr 20.