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

NCT00477724 | Unknown

• 1 other identifier: REHA/CTEPH
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

latent

Outcome Measures

Primary Outcomes (2)

• Change in 6-Minute walking test

  after 3 and 15 weeks compared to baseline

• Change in quality of life

  baseline and 15 weeks

Secondary Outcomes (8)

• physical capacity in the ergometer test

  baseline, 3 and 15 weeks

• change of lung function during 6-minute walking test

  baseline, 3 and 15 weeks

• noninvasive hemodynamic parameters

  baseline, 3 and 15 weeks

• change of systolic pulmonary arterial pressure at rest and during exercise

  baseline, 3 and 15 weeks

• change of WHO functional class

  baseline, 3 and 15 weeks

Study Arms (2)

sedentary control group

PLACEBO COMPARATOR

patients are treated by conventional rehabilitation

Other: sedentary control group

exercise and respiratory therapy

ACTIVE COMPARATOR

rehabilitation with exercise and respiratory therapy

Behavioral: exercise and respiratory therapy

Interventions

exercise and respiratory therapy BEHAVIORAL

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

exercise and respiratory therapy

sedentary control group OTHER

control group with no specific training

sedentary control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (1)

Thoraxclinic at the University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 17449958 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Exercise; Respiratory Therapy

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics

Study Officials

• Ekkehard Gruenig, MD

  Thoraxclinic at the University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekkehard Gruenig, MD

CONTACT

+49 6221 396 80 53; ekkehard.gruenig@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med. Ekkehard Grünig

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

DE (1)