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Prospective Registry to Evaluate the Effective Incidence of Chronic Thromboembolic Pulmonary Hypertension in Germany

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ClinicalTrials.gov Identifier: NCT02660463
Recruitment Status : Unknown
Verified January 2016 by Dr. Thorsten Kramm, Kerckhoff Klinik.
Recruitment status was:  Recruiting
First Posted : January 21, 2016
Last Update Posted : January 21, 2016
Sponsor:
Collaborators:
Hannover Medical School
University Hospital, Saarland
Information provided by (Responsible Party):
Dr. Thorsten Kramm, Kerckhoff Klinik

Brief Summary:
The incidence of chronic thromboembolic pulmonary hypertension (CTEPH) after acute pulmonary embolism ist not clear. It is estimated to be up to 3.8%. Prospective data registration does not exist. Treatment of choice is pulmonary endarterectomy if the thromboembolic lesions are surgically accessible. Otherwise interventional therapy by means of pulmonary balloon-angioplasty (BPA) or medical therapy is indicated. In Germany, the majority of the patients is referred to three CTEPH centers: Kerckhoff Clinic, Saarland University Hospital and Hannover Medical School to evaluate the therapeutic options. Starting in January 2016 all incident patients will be de-identified and included prospectively. Risk factors, outcome and treatment will be documented.

Condition or disease Intervention/treatment
CTEPH Chronic Thromboembolic Pulmonary Hypertension Other: Registration of the diagnosis "CTEPH"

Detailed Description:

All patients referred to the participating centers will be diagnosed in a standardized manner to confirm the diagnosis "CTEPH". No additional intervention or blood sampling is necessary. The recommended treatment option is the result of weekly CTEPH conferences. Every patient will be discussed.

The registry contains the following data:

Center PLZ Sex Age Body Mass Index History of venous thromboembolism (VTE), Date ff 1st VTE Anticoagulation and type of anticoagulation Blood group V/Q scan CT-agiography Pulmonary angiogram World Health Organisation-Functional Class six-minute walk distance Right heart catheter: RAP, PAPs, PAPd, PAPm, PAWP, CO, CI, PVR, SvO2 Treatment: PEA, Ballon Pulmonary Angioplasty (BPA), medically therapy, Vena cava filter CTEPH special risk factors: thrombophilia, antiphospholipid antibody syndrome, splenectomy, VA shunt; pacemakers

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Prospective Registry to Evaluate the Effective Incidence of Chronic Thromboembolic Pulmonary Hypertension in Germany
Study Start Date : January 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016



Intervention Details:
  • Other: Registration of the diagnosis "CTEPH"
    Registration of risk factors for thromboembolic events


Primary Outcome Measures :
  1. Diagnosis "CTEPH" confirmed [ Time Frame: 12 months ]
    Aim of the study is to detect prospectively the incidence of the diagnosis CTEPH during one year in Germany.

  2. Treatment [ Time Frame: 12 months ]
    Registration of the frequency of different treatment options, e.g. pulmonary endarterectomy, pulmonary ballon-angioplasty and medical therapy



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient with confirmed CTEPH during the year 2016 or not diagnosis confirmation not more than 6 months ago
Criteria

Inclusion Criteria:

  • diagnosis "CTEPH" confirmed

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660463


Contacts
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Contact: Thorsten Kramm, Dr. +49 6032 996 2402 t.kramm@kerckhoff-klinik.de
Contact: Stefan Guth, Dr. +49 6032 996 2402 s.guth@kerckhoff-klinik.de

Locations
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Germany
Kerckhoff Clicic Recruiting
Bad Nauheim, Germany, 61231
Contact: Thorsten Kramm, Dr.    +49 6032 996 2402    t.kramm@kerckhoff-klinik.de   
Contact: Stefan Guth, Dr.    +49 6032 996 2402    s.guth@kerckhoff-klinik.de   
Hannover Medical School Recruiting
Hannover, Germany, 30625
Contact: Marius Hoeper, MD PhD    +49 511 5323530    hoeper.marius@mh-hannover.de   
Contact: Karen Olsson, MD    +49 511 5323530    olsson.karen@mh-hannover.de   
Sponsors and Collaborators
Kerckhoff Klinik
Hannover Medical School
University Hospital, Saarland
Investigators
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Study Chair: Eckhard Mayer, Prof. Dr. Kerckhoff Klinik, Bad Nauheim, Germany
Additional Information:

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Thorsten Kramm, Dr. Thorsten Kramm, M.D., Kerckhoff Klinik
ClinicalTrials.gov Identifier: NCT02660463    
Other Study ID Numbers: CTEPH-2016
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: January 21, 2016
Last Verified: January 2016
Keywords provided by Dr. Thorsten Kramm, Kerckhoff Klinik:
incidence
risk factors
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases