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

July 12, 2022 updated by: Prof. Dr. med. Ekkehard Gruenig, Heidelberg University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: after 3 and 15 weeks compared to baseline
after 3 and 15 weeks compared to baseline
Change in quality of life
Time Frame: baseline and 15 weeks
baseline and 15 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
physical capacity in the ergometer test
Time Frame: baseline, 3 and 15 weeks
baseline, 3 and 15 weeks
change of lung function during 6-minute walking test
Time Frame: baseline, 3 and 15 weeks
baseline, 3 and 15 weeks
noninvasive hemodynamic parameters
Time Frame: baseline, 3 and 15 weeks
baseline, 3 and 15 weeks
change of systolic pulmonary arterial pressure at rest and during exercise
Time Frame: baseline, 3 and 15 weeks
baseline, 3 and 15 weeks
change of WHO functional class
Time Frame: baseline, 3 and 15 weeks
baseline, 3 and 15 weeks
change of perfusion parameters (MRI)
Time Frame: baseline, 3 and 15 weeks
baseline, 3 and 15 weeks
change of respiratory muscle function
Time Frame: baseline and 15 weeks
baseline and 15 weeks
change of NTproBNP
Time Frame: baseline, 3 and 15 weeks
baseline, 3 and 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REHA/CTEPH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Hypertension

Clinical Trials on sedentary control group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe