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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension; Chronic Thromboembolic Pulmonary Hypertension
• Intervention / Treatment: Other: sedentary control group; Behavioral: exercise and respiratory therapy

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ekkehard Gruenig, MD; Phone Number: +49 6221 396 80 53; Email: ekkehard.gruenig@med.uni-heidelberg.de

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Recruiting
      • Thoraxclinic at the University Hospital Heidelberg
      • Principal Investigator: Ekkehard Gruenig, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: sedentary control group; patients are treated by conventional rehabilitation	Other: sedentary control group; control group with no specific training
Active Comparator: exercise and respiratory therapy; rehabilitation with exercise and respiratory therapy	Behavioral: exercise and respiratory therapy; exercise and respiratory therapy for three weeks in-hospital and 15 weeks at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in 6-Minute walking test	after 3 and 15 weeks compared to baseline
Change in quality of life	baseline and 15 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
change of perfusion parameters (MRI)	baseline, 3 and 15 weeks
change of respiratory muscle function	baseline and 15 weeks
change of NTproBNP	baseline, 3 and 15 weeks

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Ekkehard Gruenig, MD, Thoraxclinic at the University Hospital Heidelberg

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 22, 2007
• First Submitted That Met QC Criteria: May 22, 2007
• First Posted (Estimate): May 24, 2007

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: latent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: REHA/CTEPH