Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02656238
  4. Details
NCT02656238 Clinical Trial

New International CTEPH Database

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

Official title:
New International CTEPH Database

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02656238
Other study ID # CTEPH Registry
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date January 2020

Study information
Verified date August 2022
Source International CTEPH Association
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The New International CTEPH Database is a prospective, observational multi-center disease registry run by the International CTEPH Association (ICA), which will collect data in chronic thromboembolic pulmonary hypertension (CTEPH) patients worldwide. The registry will run for approximately 5 years. Its objective is to provide an overview on epidemiology of CTEPH, mode of diagnosis and treatment approaches worldwide as well as determinants of long-term outcomes as measured by New York Heart Association (NYHA) functional class and survival. The data collected will improve the knowledge and understanding of this condition, support the further development of diagnosis and treatment guidelines for patients with CTEPH, and contribute to improving patient care in the long-term.

Recruitment information / eligibility
Status Completed
Enrollment 1019
Est. completion date January 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients must be newly diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH) (incident patients) - Patients must have been treated with anti-coagulation for at least 3 months before diagnosis of CTEPH - Patients must be willing to provide informed consent - Patients must meet the following criteria for CTEPH: - Mean pulmonary artery pressure (PAP) = 25 mmHg at rest - Abnormal VQ scan, pulmonary angiogram, computed tomography (CT) pulmonary angiogram, or magnetic resonance (MR) pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines Exclusion Criteria: - None specified

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Australia St Vincent's Hospital Darlinghurst
Australia The Alfred Hospital Prahran
Austria University Clinics of Vienna Vienna
Belgium University Hospitals of Leuven Leuven
Brazil University of Sao Paulo Medical School Sao Paulo
Brazil Hospital São Paulo, Federal University of São Paulo São Paulo
Canada Toronto General Hospital Toronto Ontario
Denmark Aarhus University Hospital Aarhus
Egypt Kasr Alaini School of Medicine Cairo
Finland Helsinki University Hospital Helsinki
Germany Kerckhoff-Klinik GmbH Bad Nauheim
Germany Medizinische Hochschule Hannover Hannover
Germany Universitätsklinikum des Saarlandes Homburg
Italy University of Pavia Pavia
Japan Chiba University Hospital Chiba
Japan Kobe University Graduate School of Medicine Kobe
Japan National Hospital Organization Okayama Okayama
Japan Kyorin University Hospital Tokyo
Korea, Republic of Samsung Medical Center Seoul
Netherlands VU University Medical Center Amsterdam
Poland Europejskim Centrum Zdrowia Otwock Otwock
Poland Medical University of Warsaw Warsaw
Poland Wojewódzki Szpital Specjalistyczny Wroclaw
Russian Federation Cardiology Research Center Moscow
Russian Federation Novosibirsk Research Institute of Circulation Pathology Academician E.N.Meshalkin Novosibirsk
Slovakia Slovak Medical University and National Institute for Cardiovascular Diseases Bratislava
Spain Hospital Clinic Barcelona Barcelona
Spain Hospital Universitarion 12 Octubre Madrid
Switzerland UniversitätsSpital Zürich Zürich
Taiwan National Taiwan University Hospital Taipei City
Turkey Marmara University School of Medicine Istanbul
United Kingdom Papworth Hospital Cambridge
United Kingdom Western Infirmary Glasgow
United Kingdom Royal Free London NHS Foundation Trust London
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Sheffield
United States University of Maryland Baltimore Maryland
United States Cleveland Clinic Cleveland Ohio
United States UC San Diego La Jolla California

Sponsors (1)
Lead Sponsor Collaborator
International CTEPH Association

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Denmark,  Egypt,  Finland,  Germany,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Slovakia,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

References & Publications (1)

Guth S, D'Armini AM, Delcroix M, Nakayama K, Fadel E, Hoole SP, Jenkins DP, Kiely DG, Kim NH, Lang IM, Madani MM, Matsubara H, Ogawa A, Ota-Arakaki JS, Quarck R, Sadushi-Kolici R, Simonneau G, Wiedenroth CB, Yildizeli B, Mayer E, Pepke-Zaba J. Current str — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Death Min. 3 years
Primary Lung transplantation Min. 3 years
Primary Change in New York Heart Association (NYHA) functional class Min 3. years
Secondary Age at diagnosis Min. 3 years
Secondary Gender Min. 3 years
Secondary Ethnicity Min. 3 years
Secondary Disease severity As measured by New York Heart Association (NYHA) functional class Min. 3 years
Secondary History of deep vein thrombosis (DVT) Min. 3 years
Secondary History of acute pulmonary embolism Min. 3 years
Secondary Hemodynamic parameters Min. 3 years
Secondary Patient on oxygen (yes/no) Min. 3 years
Secondary Medical treatment e.g. mono- versus combination therapy Min. 3 years
Secondary Pulmonary endarterectomy (PEA) e.g. operated versus non-operated Min. 3 years
Secondary Balloon pulmonary angioplasty (BPA) e.g. BPA versus pulmonary endarterectomy (PEA) Min. 3 years
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06003244 - High Altitude (HA) Residents With Pulmonary Vascular Diseases (PVD), 6 Minute Walk Distance (6MWD) Assessed at 2840m (HA) With and Without Supplemental Oxygen Therapy (SOT) N/A
Active, not recruiting NCT06092424 - High Altitude (HA) Residents With Pulmonary Vascular Diseseases (PVD), Pulmonary Artery Pressure (PAP) Assessed at HA (2840m) vs Sea Level (LA) N/A
Active, not recruiting NCT06072417 - HA Residents With PVD, SDB Assessed at HA (2840m) vs LA (Sea Level) N/A
Terminated NCT01953965 - Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI. Phase 2
Recruiting NCT02061787 - the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension
Not yet recruiting NCT03102294 - Inspiratory Muscle Training in Chronic Thromboembolic Pulmonary Hypertension N/A
Recruiting NCT04071327 - Pulmonary Hypertension Association Registry
Completed NCT00313222 - Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension Phase 3
Recruiting NCT05311072 - Change-a Multi-center Chronic Thromboembolic Pulmonary Hypertension （CTEPH） Database in China
Recruiting NCT05340023 - Proteomic Pattern Associated With the Diagnosis of Chronic Thromboembolic Pulmonary Hypertension
Enrolling by invitation NCT05568927 - Validation of SEARCH, a Novel Hierarchical Algorithm to Define Long-term Outcomes After Pulmonary Embolism
Completed NCT03786367 - Dyspnea in Chronic Thromboembolic Pulmonary Hypertension
Recruiting NCT04081012 - N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension. N/A
Not yet recruiting NCT06384534 - Exercise Performance on Ambient Air vs. Low-Flow Oxygen Therapy in Pulmonary Vascular Disease (PVD) N/A
Withdrawn NCT05693779 - Exercise Therapy After Pulmonary Thromboendarterectomy or Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension N/A
Not yet recruiting NCT02426203 - 3D Echocardiographic Assessment of RV Function in Patients Undergoing Pulmonary Endarterectomy N/A
Completed NCT02094001 - Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPH Phase 2
Enrolling by invitation NCT03388476 - Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension
Recruiting NCT04206852 - Safety and Efficacy of Balloon Pulmonary Angioplasty in China
Completed NCT02111980 - RF Surgical Sponge-Detecting System on the Function of Pacemakers and Implantable Cardioverter Defibrillators N/A

External Links