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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
ClinicalTrials.gov Identifier:
NCT00477724
First received: May 22, 2007
Last updated: July 1, 2014
Last verified: July 2014

May 22, 2007
July 1, 2014
June 2007
June 2015   (final data collection date for primary outcome measure)
  • Change in 6-Minute walking test [ Time Frame: after 3 and 15 weeks compared to baseline ] [ Designated as safety issue: No ]
  • Change in quality of life [ Time Frame: baseline and 15 weeks ] [ Designated as safety issue: No ]
  • Change in 6-Minute walking test [ Time Frame: after 3 and 15 weeks compared to baseline ]
  • Change in quality of life
Complete list of historical versions of study NCT00477724 on ClinicalTrials.gov Archive Site
  • physical capacity in the ergometer test [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of lung function during 6-minute walking test [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • noninvasive hemodynamic parameters [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of systolic pulmonary arterial pressure at rest and during exercise [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of WHO functional class [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of perfusion parameters (MRI) [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • change of respiratory muscle function [ Time Frame: baseline and 15 weeks ] [ Designated as safety issue: No ]
  • change of NTproBNP [ Time Frame: baseline, 3 and 15 weeks ] [ Designated as safety issue: No ]
  • physical capacity in the ergometer test
  • change of lung function during 6-minute walking test
  • noninvasive hemodynamic parameters
  • change of systolic pulmonary arterial pressure at rest and during exercise
  • change of WHO functional class
  • change of perfusion parameters (MRI)
  • change of respiratory muscle function
  • change of NTproBNP
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Chronic Thromboembolic Pulmonary Hypertension
  • 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
  • Placebo Comparator: sedentary control group
    patients are treated by conventional rehabilitation
    Intervention: Other: sedentary control group
  • Active Comparator: exercise and respiratory therapy
    rehabilitation with exercise and respiratory therapy
    Intervention: Behavioral: exercise and respiratory therapy
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 Apr 20; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
Not Provided
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Ekkehard Gruenig, MD +49 6221 396 80 53 ekkehard.gruenig@med.uni-heidelberg.de
Germany
 
NCT00477724
REHA/CTEPH
Not Provided
Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
Heidelberg University
Not Provided
Principal Investigator: Ekkehard Gruenig, MD Thoraxclinic at the University Hospital Heidelberg
Heidelberg University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP