Clinical trial NCT05629052: TrEatment Approach in the Multimodal Era Registry
Official title: TrEatment Approach in the Multimodal Era Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Thromboembolic Pulmonary Hypertension
CTEPH
Keywords: Chronic thromboembolic pulmonary hypertension
CTEPH
Pulmonary endarterectomy
PEA
Balloon pulmonary angioplasty
BPA
Multimodal treatment
Lead sponsor: International CTEPH Association
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceuticals
First posted: 2022-11-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from CTEPH or CTEPD without PH who are newly referred to an expert center and who meet all of the inclusion criteria and none of the exclusion criteria

Brief summary: The goal of this observational patient registry is to learn how expert centers treat patients with chronic thromboembolic pulmonary hypertension (CTEPH). CTEPH is a condition in which blood clots block the blood vessels in the lungs. There are currently three treatment options for patients with CTEPH:

* surgery to remove blood clots from large vessels in the lungs (pulmonary endarterectomy (PEA))
* the use of a small balloon to unblock smaller blood vessels (balloon pulmonary angioplasty (BPA))
* drugs

Patients can also receive a combination of these treatments.

The main question this registry aims to answer are:

* How many patients receive a given kind of treatment?
* How do expert centers combine the different treatments?
* Are patients doing better after they receive a given kind of treatment?
* How many patients are alive 1, 3 and 5 years after they receive a given kind of treatment?

Participants will receive the same treatments that they would receive if they did not participate in the study. During the study, patients will visit their doctors as they would do normally. The doctors will collect information on the patients' health and enter it into the study database. The follow-up time will be at least 3 years for all patients.


Eligibility criteria: Inclusion Criteria:

1. Newly referred patient with CTEPH or chronic thromboembolic pulmonary disease (CTEPD) without PH according to the following criteria:

   1. Mean pulmonary arterial pressure (mPAP) \> 20 mmHg at rest with pulmonary vascular resistance (PVR) \> 2 Wood units (WU); or if mPAP ≤ 20 mmHg or PVR ≤ 2 WU at rest, have exercise limitations from CTEPD without PH
   2. Abnormal ventilation perfusion scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming CTEPD as recommended by standard guidelines
2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH or CTEPD without PH
3. Naïve to interventional treatment (both PEA and BPA)
4. Pre-treatment with PH-specific medication for ≤ 12 months, or no medical pre-treatment, at enrollment
5. Willing and able to provide informed consent in order to participate in the study (informed consent signed)
6. Age ≥ 18 years
7. CTEPH-specific treatment must be modified or initiated at the participating site

Exclusion Criteria:

1. Main cause of PH other than CTEPH
2. Participating in an interventional clinical trial at enrollment

Primary outcomes:
measure: Utilization and combination of treatment modalities
timeFrame: Min. 3 years
measure: 3-year survival
timeFrame: 3 years after last intervention
Secondary outcomes:
measure: Complications of treatment interventions (per patient)
timeFrame: Min. 3 years
measure: Complications of treatment interventions (per BPA session)
timeFrame: Min. 3 years
measure: 1-year survival
timeFrame: 1 year after last intervention
measure: 5-year survival
timeFrame: 5 year after last intervention
measure: Changes in PH-specific medication
timeFrame: Min. 3 years
measure: Reason why PEA was not performed
timeFrame: Min. 3 years
measure: Reason why BPA was not performed
timeFrame: Min. 3 years
Other outcomes:
measure: Number of unplanned hospitalizations
timeFrame: Min. 3 years
measure: Timing of unplanned hospitalizations
timeFrame: Min. 3 years
measure: Frequency of QoL assessment
timeFrame: Min. 3 years
measure: Type of QoL questionnaire
timeFrame: Min. 3 years
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Fundación Favaloro
city: Vienna
country: Austria
facility: University Hospital Vienna
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Porto Alegre
country: Brazil
facility: Santa Casa
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Bogotá
country: Colombia
facility: Shaio Clinic Foundation
city: Prague
country: Czech Republic
facility: General University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Bad Nauheim
country: Germany
facility: Kerckhoff Clinic, Department of Thoracic Surgery
city: Bangalore
country: India
facility: Narayana Institute of Cardiac Science
city: Bologna
country: Italy
facility: University of Bologna
city: Okayama
country: Japan
facility: Okayama Medical Center
city: Osaka
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Mexico City
country: Mexico
facility: National Heart Institute
city: Kraków
country: Poland
facility: Department of Cardiac and Vascular Diseases, John Paul II Hospital
city: Otwock
country: Poland
facility: Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, European Health Center Otwock
city: Singapore
country: Singapore
facility: National Heart Centre of Singapore
city: Madrid
country: Spain
facility: Pulmonary Hypertension Unit, Hospital 12 de Octubre
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital
Study officials:
affiliation: University of California, San Diego
name: Nick H Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: