Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Multicentre observational screenINg survey for the detection of chronic thromboembolic PUlmonary hyperTensiON (CTEPH) following Pulmonary Embolism
Acronym
INPUT ON PE
Study hypothesis
1. To evaluate the incidence rate of symptomatic chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary embolism (PE)
2. To identify and evaluate potential risk factors for developing CTEPH following PE
3. To test the usefulness of a screening algorithm based on dyspnoea in medical practice for diagnosing CTEPH after confirmed PE
Ethics approval
Commission d'ethique de la recherche Lausanne approved on the 17th February 2009 (ref: 226/08)
Study design
Prospective multicentre observational phase V study
Primary study design
Observational
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pulmonary embolism/chronic thromboembolic pulmonary hypertension
Intervention
Patients with confirmed pulmonary embolism are followed up by regular telephone contacts at 6, 12 and 24 months using a standardised dyspnoea questionnaire. If the questionnaire discovers previously unreported symptoms of dyspnoea, patients are invited to the centre for confirmation of dyspnoea and, if confirmed, an echocardiography will be performed.
In case of a suspicion of PH at echocardiography, right heart catheterisation is performed for the confirmation of PH. CTEPH is confirmed if mean pulmonary arterial pressure (mPAP) greater than or equal to 25 mmHg, pulmonary capillary wedge pressure (PCWP) less than 15 mmHg and pulmonary vascular resistance (PVR) greater than or equal to 300 dyn*sec/cm^5 (3.75 Wood units), and additionally if V/Q scan shows a mismatch or imaging of the lung vessels show a pulmonary vessel obstruction. Any other causes of dyspnoea or elevated PH have to be excluded.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Amount of patients who develop symptomatic CTEPH at 6, 12 and 24 months after PE.
Secondary outcome measures
1. Comparison of collected baseline data of the patients who developed CTEPH with the baseline data of the patients who did not develop CTEPH within the 2-year period after diagnosis of PE to identify any potential risk factors
2. Comparison of the results of the dyspnoea questionnaire answered by telephone with the dyspnoea evaluation by the investigator at the clinic to test the usefulness of the telephone screening algorithm in medical practice for diagnosing CTEPH after PE
Overall trial start date
18/05/2009
Overall trial end date
01/04/2013
Reason abandoned
Eligibility
Participant inclusion criteria
Men and women (no age limitations) with pulmonary embolism within the preceding 4 weeks, demonstrated by:
1. Pulmonary angiography, or
2. Contrast enhanced spiral computed tomography, or
3. High probability lung scintigraphy (perfusion and ventilation imaging)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
1. Confirmed diagnosis of pulmonary arterial hypertension (PAH) or CTEPH before inclusion
2. Pre-existing severe chronic dyspnoea (New York Heart Association [NYHA] grade III or IV) due to other reasons than PE
3. Cancer or other life-threatening disease with a life expectancy less than 6 months
Recruitment start date
18/05/2009
Recruitment end date
01/04/2013
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Lausanne
Lausanne
1011
Switzerland
Sponsor information
Organisation
Swiss Society for Pulmonary Hypertension (Switzerland)
Sponsor details
c/o IMK Institut für Medizin und Kommunikation AG
Münsterberg 1
Basel
4001
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Swiss Society for Pulmonary Hypertension (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary