Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02660463
Enrollment
500
Registered
2016-01-21
Start date
2016-01-31
Completion date
2016-12-31
Last updated
2016-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Thromboembolic Pulmonary Hypertension, CTEPH

Keywords

incidence, risk factors

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

Interventions

OTHERRegistration of the diagnosis CTEPH

Registration of risk factors for thromboembolic events

Sponsors

Hannover Medical School
CollaboratorOTHER
University Hospital, Saarland
CollaboratorOTHER
Kerckhoff Klinik
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* diagnosis CTEPH confirmed

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis CTEPH confirmed12 monthsAim of the study is to detect prospectively the incidence of the diagnosis CTEPH during one year in Germany.
Treatment12 monthsRegistration of the frequency of different treatment options, e.g. pulmonary endarterectomy, pulmonary ballon-angioplasty and medical therapy

Countries

Germany

Contacts

Primary ContactThorsten Kramm, Dr.
t.kramm@kerckhoff-klinik.de+49 6032 996 2402
Backup ContactStefan Guth, Dr.
s.guth@kerckhoff-klinik.de+49 6032 996 2402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026