Clinical trial NCT03245268: International BPA Registry
Official title: International BPA Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Thromboembolic Pulmonary Hypertension
CTEPH
Keywords: Balloon pulmonary angioplasty
BPA
Lead sponsor: International CTEPH Association
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with CTEPH meeting the inclusion criteria listed below and scheduled to undergo BPA intervention are eligible for inclusion into the International BPA Registry.

Brief summary: The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).


Eligibility criteria: Inclusion Criteria:

* Diagnosis with CTEPH according to the following criteria:

  * Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease
  * Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
* Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
* Naïve to BPA treatment
* Scheduled to undergo their first BPA session ≥ 1 day after enrollment. Enrollment is defined as date the consent is signed by the patient. Enrollment must occur before any BPA session
* Willing to provide informed consent

Exclusion Criteria:

* BPA treatment prior to enrollment
* Pulmonary hypertension cause other than World Health Organization (WHO) group IV (CTEPH)
* Targeted BPA treatment lesion other than from WHO group IV (CTEPH)

Primary outcomes:
measure: Safety as assessed by BPA-associated complications
timeFrame: Min. 2 years
measure: Efficacy as assessed by change in PVR
timeFrame: Min. 2 years
measure: Efficacy as assessed by change in mPAP
timeFrame: Min. 2 years
Secondary outcomes:
measure: Compare volume of BPA cases across regions and case load at the end of recruitment
timeFrame: Min. 2 years
measure: Analyze patient selection criteria for BPA across sites at the end of recruitment
timeFrame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as asssed by imaging modalities as used by the sites
timeFrame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as assessed by investigator-reported session goals
timeFrame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as assessed by number of sessions per patient and follow-up
timeFrame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as assessed by number of interventions per patient and follow-up
timeFrame: Min. 2 years
measure: At the end of follow-up, compare technical aspects of BPA as assessed by technical limits
timeFrame: Min. 2 years
measure: Analyze the use of PH targeted medical therapy before BPA
timeFrame: Min. 2 years
measure: Analyze the use of PH targeted medical therapy after BPA
timeFrame: Min. 2 years
measure: Analyze the impact of PH targeted medical treatment on key patient outcomes
timeFrame: Min. 2 years
measure: Health care resource use required to complete BPA
timeFrame: Min. 2 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Vienna
country: Austria
facility: University Clinics
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
city: Prague
country: Czechia
facility: General University Hospital
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble-Alpes
city: Le Plessis-Robinson
country: France
facility: L'Hôpital Marie Lannelongue
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Osaka
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Amsterdam
country: Netherlands
facility: VU Medical Center
city: Warsaw
country: Poland
facility: European Health Center Otwock LLC
city: Cambridge
country: United Kingdom
facility: Papworth Hospital
Study officials:
affiliation: International CTEPH Association
name: Nick H Kim, Prof
role: PRINCIPAL_INVESTIGATOR
References: