Detection of chronic thromboembolic pulmonary hypertension (CTEPH) following pulmonary embolism

ISRCTN	ISRCTN61417303
DOI	https://doi.org/10.1186/ISRCTN61417303
Protocol serial number	N/A
Sponsor	Swiss Society for Pulmonary Hypertension (Switzerland)
Funder	Swiss Society for Pulmonary Hypertension (Switzerland)

Submission date: 12/05/2009
Registration date: 29/06/2009
Last edited: 08/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr John-David Aubert
Scientific

University Hospital Lausanne
Rue du Bugnon
Lausanne
1011
Switzerland

Study information

Primary study design	Observational
Study design	Prospective multicentre observational phase V study
Secondary study design	Single-centre
Study type	Participant information sheet
Scientific title	Multicentre observational screenINg survey for the detection of chronic thromboembolic PUlmonary hyperTensiON (CTEPH) following Pulmonary Embolism
Study acronym	INPUT ON PE
Study objectives	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(s)	Commission d'ethique de la recherche Lausanne approved on the 17th February 2009 (ref: 226/08)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Amount of patients who develop symptomatic CTEPH at 6, 12 and 24 months after PE.
Key secondary outcome measure(s)	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
Completion date	01/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1000
Total final enrolment	508
Key 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)
Key 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
Date of first enrolment	18/05/2009
Date of final enrolment	01/04/2013

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Lausanne

Lausanne
1011
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/04/2018	08/05/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

08/05/2019: Total final enrolment and publication reference were added.