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New International CTEPH Database

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ClinicalTrials.gov Identifier: NCT02656238
Recruitment Status : Active, not recruiting
First Posted : January 14, 2016
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
International CTEPH Association

Tracking Information
First Submitted Date January 12, 2016
First Posted Date January 14, 2016
Last Update Posted Date August 27, 2019
Study Start Date February 2015
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 12, 2016)
  • Death [ Time Frame: Min. 3 years ]
  • Lung transplantation [ Time Frame: Min. 3 years ]
  • Change in New York Heart Association (NYHA) functional class [ Time Frame: Min 3. years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02656238 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 12, 2016)
  • Age at diagnosis [ Time Frame: Min. 3 years ]
  • Gender [ Time Frame: Min. 3 years ]
  • Ethnicity [ Time Frame: Min. 3 years ]
  • Disease severity [ Time Frame: Min. 3 years ]
    As measured by New York Heart Association (NYHA) functional class
  • History of deep vein thrombosis (DVT) [ Time Frame: Min. 3 years ]
  • History of acute pulmonary embolism [ Time Frame: Min. 3 years ]
  • Hemodynamic parameters [ Time Frame: Min. 3 years ]
  • Patient on oxygen (yes/no) [ Time Frame: Min. 3 years ]
  • Medical treatment [ Time Frame: Min. 3 years ]
    e.g. mono- versus combination therapy
  • Pulmonary endarterectomy (PEA) [ Time Frame: Min. 3 years ]
    e.g. operated versus non-operated
  • Balloon pulmonary angioplasty (BPA) [ Time Frame: Min. 3 years ]
    e.g. BPA versus pulmonary endarterectomy (PEA)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title New International CTEPH Database
Official Title New International CTEPH Database
Brief 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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Patients recently diagnosed with chronic thromboembolic pulmonary hypertension (CTEPH), meeting the registry's inclusion criteria, are eligible for inclusion into the New International CTEPH Database.

Only newly diagnosed, i.e. incident patients are eligible for inclusion. A patient is considered an incident patient if a diagnostic heart catheterization was performed within 1 year prior to the initial inclusion visit (for the first patient included) at the site participating in the New International CTEPH Database.

Condition
  • Chronic Thromboembolic Pulmonary Hypertension
  • CTEPH
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 21, 2016)
1019
Original Estimated Enrollment
 (submitted: January 12, 2016)
800
Estimated Study Completion Date January 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries 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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02656238
Other Study ID Numbers CTEPH Registry
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party International CTEPH Association
Study Sponsor International CTEPH Association
Collaborators Not Provided
Investigators Not Provided
PRS Account International CTEPH Association
Verification Date August 2019