NCT02555137: InShape2

Early Non-invasive Detection of CTEPH After Pulmonary Embolism

Completed Last updated 9 February 2021

What this trial tests

trial testing 'prediction score' and 'rule-out criteria' in Chronic Thromboembolic Pulmonary Hypertension in 424 participants. Completed in 1 December 2019.

Timeline

1 February 2016

Primary endpoint
1 November 2019

1 December 2019

Quick facts

Lead sponsor	Leiden University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	424
Start date	1 February 2016
Primary completion	1 November 2019
Estimated completion	1 December 2019
Sites	5 locations across Belgium, Netherlands, Poland

Drugs / interventions tested

• 'prediction score' and 'rule-out criteria'

Conditions studied

• Chronic Thromboembolic Pulmonary Hypertension — all drugs for Chronic Thromboembolic Pulmonary Hypertension →

Sponsor

Leiden University

Who can join

18 and older, any sex, with Chronic Thromboembolic Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, international, multicenter outcome cohort study. This study starts at the moment patients visit the outpatient clinic 3 to 6 months after a diagnosis of acute PE as part of routine medical care. If patients consent to study participation, the CTEPH clinical prediction score will be calculated. CTEPH is considered to be not present in patients with a low probability (≤6 points) and no symptoms suggestive of CTEPH, i.e. dyspnea on exertion, edema, newly developed palpitations, syncope or chest pains.The remaining patients with either high probability (\>6 points) or who report symptoms that may be associated with CTEPH will be subjected to the 'rule-out criteria'. CTEPH will be assumed not present in patients with an age- and gender dependent normal NT-proBNP level (as defined by the assay's manufacturer), in the absence of any of the 3 ECG criteria. Patients who have an abnormal result from the 'rule-out criteria' will be referred for transthoracic echocardiography. All echocardiograms will be performed according to a predefined standardized protocol.

In case of echocardiographic intermediate or high probability of PH, patients will be referred for further diagnostic work-up of suspected CTEPH starting with perfusion lung scan or VQ-scan and right heart catheterization, of which the results will be discussed by an independent interdisciplinary working group of PH specialists, to ensure optimal diagnostic management. This latter diagnostic work-up of an abnormal echocardiograph lies within the setting of standard medical care.

All patients who were not diagnosed with pulmonary hypertension of any origin, or with NYHA class III or IV heart failure due to left ventricular systolic dysfunction, left ventricular diastolic dysfunction or significant valvular lesions, will be followed for a total of 2 years from the index PE diagnosis. During that period, the study protocol will not interfere with standard patient care, allowing diagnostic tests as deemed indicated by the treating physician including echocardiography in case of new respiratory symptoms. At the end of the follow-up period, all patients will be subjected to a second echocardiography that will be handled according to the above stated procedures to evaluate the presence of CTEPH.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Sensitivity of a Simple Noninvasive Screening Algorithm for Chronic Thromboembolic Pulmonary Hypertension after Acute Pulmonary Embolism.
   Ende-Verhaar YM, Ruigrok D, Bogaard HJ, Huisman MV, et al · · 2018 · cited 16× · PMID 31249932 · DOI 10.1055/s-0038-1636537