Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07506291
NA

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

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

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