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

Pulmonary Hypertension Clinical Trial

Official title:

Incidence of Latent Pulmonary Hypertension in Patients With Chronic Thromboembolic Pulmonary Hypertension After Endarterectomy and Influence of Exercise and Respiratory Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00477724
• Other study ID #: REHA/CTEPH
• Status: Recruiting
• Phase: N/A
• Start date: June 2007
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Heidelberg University
• Contact: Ekkehard Gruenig, MD
• Phone: +49 6221 396 80 53
• Email: ekkehard.gruenig[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Other:
• sedentary control group
control group with no specific training

Locations

Country	Name	City	State
Germany	Thoraxclinic at the University Hospital Heidelberg	Heidelberg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Mereles D, Ewert R, Lodziewski S, Borst MM, Benz A, Olschewski H, Grünig E. Effect of inhaled iloprost during off-medication time in patients with pulmonary arterial hypertension. Respiration. 2007;74(5):498-502. Epub 2007 Apr 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6-Minute walking test		after 3 and 15 weeks compared to baseline
Primary	Change in quality of life		baseline and 15 weeks
Secondary	physical capacity in the ergometer test		baseline, 3 and 15 weeks
Secondary	change of lung function during 6-minute walking test		baseline, 3 and 15 weeks
Secondary	noninvasive hemodynamic parameters		baseline, 3 and 15 weeks
Secondary	change of systolic pulmonary arterial pressure at rest and during exercise		baseline, 3 and 15 weeks
Secondary	change of WHO functional class		baseline, 3 and 15 weeks
Secondary	change of perfusion parameters (MRI)		baseline, 3 and 15 weeks
Secondary	change of respiratory muscle function		baseline and 15 weeks
Secondary	change of NTproBNP		baseline, 3 and 15 weeks