Condition category
Circulatory System
Date applied
12/05/2009
Date assigned
29/06/2009
Last edited
29/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr John-David Aubert

ORCID ID

Contact details

University Hospital Lausanne
Rue du Bugnon
Lausanne
1011
Switzerland

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

http://www.sgph.ch/WebHome

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

Publication citations

Additional files

Editorial Notes