Latent Pulmonary Hypertension (PH) in Chronic Thromboembolic Pulmonary Hypertension (CTEPH )After Endarterectomy and Influence of Exercise and Respiratory Therapy

NCT ID: NCT00477724

Last Updated: 2022-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2023-12-31

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.

Conditions

Pulmonary Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sedentary control group

patients are treated by conventional rehabilitation

Group Type: PLACEBO_COMPARATOR

sedentary control group

Intervention Type: OTHER

control group with no specific training

exercise and respiratory therapy

rehabilitation with exercise and respiratory therapy

Group Type: ACTIVE_COMPARATOR

exercise and respiratory therapy

Intervention Type: BEHAVIORAL

exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home

Interventions

exercise and respiratory therapy

exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home

Intervention Type: BEHAVIORAL

sedentary control group

control group with no specific training

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ekkehard Gruenig, MD

Role: PRINCIPAL_INVESTIGATOR

Thoraxclinic at the University Hospital Heidelberg

Locations

Thoraxclinic at the University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Ekkehard Gruenig, MD

Role: CONTACT

ekkehard.gruenig@med.uni-heidelberg.de

+49 6221 396 80 53

References

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.

Reference Type: BACKGROUND

PMID: 17449958 (View on PubMed)

Other Identifiers

REHA/CTEPH

Identifier Type: -

Identifier Source: org_study_id