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HOME-PE2 : Home Treatment Versus Hospitalization in Patients With Acute Pulmonary Embolism, no Clinical Severity Criteria, and Either Right Ventricular Dysfunction or Elevated Troponin: a Randomized Controlled Trial
Sponsor: University Hospital, Angers
Summary
This study (HOME-PE2) is a multicenter, randomized controlled trial comparing home treatment versus hospitalization in patients with acute pulmonary embolism (PE) who have no clinical severity criteria according to the Hestia rule but present either right ventricular dysfunction or elevated cardiac troponin levels. While outpatient management is considered safe for low-risk PE patients, the optimal management of patients without clinical severity but with signs of right ventricular strain or myocardial injury remains uncertain, and current guidelines are inconsistent. As a result, most of these patients are still hospitalized despite limited evidence supporting this approach. The primary objective is to assess whether home treatment is non-inferior to hospitalization in terms of safety, defined by the 7-day rate of adverse events according to the EARTH consensus. Secondary objectives include evaluation of net clinical benefit, quality of life, functional status, and healthcare resource utilization, as well as exploration of sex-related differences and cost-effectiveness. A total of 568 adult patients with confirmed PE will be randomized (1:1) to either home treatment with early discharge or standard hospitalization. Patients will be followed for 90 days.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
568
Start Date
2026-06
Completion Date
2029-09
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Home treatment
Outpatient management strategy for acute pulmonary embolism, including early discharge after diagnosis and initiation of anticoagulation therapy, with follow-up according to current guidelines and local practice.
Hospitalization
Inpatient management strategy for acute pulmonary embolism, including hospital admission and standard care with anticoagulation therapy according to current guidelines and local practice.
Locations (18)
Angers University Hospital, Emergency Department
Angers, France
Argenteuil hospital, Emergency department
Argenteuil, France
Brest University Hospital (site Cavale Blanche), Cardiology Department
Brest, France
Cholet Hospital, Emergency department
Cholet, France
Clermont-Ferrand University Hospital, Emergency department
Clermont-Ferrand, France
Paris University Hospital (APHP - site Louis Mourier), Emergency Department
Colombes, France
Grenoble University Hospital, Emergency Department
Grenoble, France
Le Mans Hospital, Emergency department
Le Mans, France
Lyon University Hospital (site Edouard Herriot), Emergency Department
Lyon, France
Nantes University Hospital, Emergency department
Nantes, France
Paris University Hospital (APHP - site Lariboisière hospital), emergency department
Paris, France
Paris University Hospital (APHP - site La Pitié-Salpétrière Hospital), Emergency Department
Paris, France
Paris University Hospital (APHP - site HEGP), Emergency Department
Paris, France
Paris University Hospital (APHP, site Hôpital Européen Georges Pompidou), Pneumology department
Paris, France
Lyon University Hospital (site Lyon Sud), Emergency department
Pierre-Bénite, France
Poitiers University Hospital, Emergency Department
Poitiers, France
Rouen University Hospital, Emergency Department
Rouen, France
Toulouse University Hospital, Emergency Department
Toulouse, France