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

January 20, 2016 updated by: Dr. Thorsten Kramm, Kerckhoff Klinik
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

500

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 Contact Backup

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • diagnosis "CTEPH" confirmed

Exclusion Criteria:

-

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Kerckhoff Klinik

Collaborators

Hannover Medical School
University Hospital, Saarland

Investigators

  • Study Chair: Eckhard Mayer, Prof. Dr., Kerckhoff Klinik, Bad Nauheim, Germany

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

January 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTEPH-2016

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 Chronic Thromboembolic Pulmonary Hypertension

Clinical Trials on Registration of the diagnosis "CTEPH"

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe