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

• Conditions: CTEPH; Chronic Thromboembolic Pulmonary Hypertension

• Registration Number: NCT02660463
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-20
• Last Update Submitted: 2016-01-20
• Study First Posted: 2016-01-21
• Last Update Posted: 2016-01-21
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• diagnosis "CTEPH" confirmed

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnosis "CTEPH" confirmed	12 months	Aim of the study is to detect prospectively the incidence of the diagnosis CTEPH during one year in Germany.
Treatment	12 months	Registration of the frequency of different treatment options, e.g. pulmonary endarterectomy, pulmonary ballon-angioplasty and medical therapy

Trial Locations

Locations (2)

Kerckhoff Clicic; 🇩🇪 Bad Nauheim, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany