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

Starting soon · Not applicable

Conditions studied: Acute Pulmonary Embolism

In brief

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 facts

Study ID

NCT07506291

Run by

University Hospital, Angers

People needed

568

Starts

2026-06-01

Expected to finish

2029-09-01

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presentation to the Emergency Department or unscheduled consultation in one of the participating centers
• Symptomatic PE objectively confirmed according to the European Society of Cardiology criteria 4 (either by i) a high-probability ventilation/perfusion lung scan, ii) a new contrast filling defect on spiral computed tomography, or iii) a new documentation by ultrasonography of a proximal DVT, i.e., thrombus in the popliteal vein or above, along with clinical signs of PE. All radiological tests used to diagnose PE will be interpreted by on-site radiologists or angiologists)
• No clinical criteria mandating hospitalization according to the Hestia rule, i.e., negative Hestia rule
• Right ventricular dysfunction - defined as a right ventricular (RV) to left ventricular (LV) diameter ratio > 1.0 on echocardiography (apical four-chamber or subcostal four-chamber view) or on CTPA (transverse plane) OR High-sensibility cardiac troponin I or T concentration above the upper limit of local normal value
• Insurance cover according to local legislation
• Age ≥18 years
• Signed free informed consent (or oral consent if possible according to local regulation).

You may not qualify if…

• Shock or hypotension (defined as systolic blood pressure <90 mmHg or a systolic pressure drop by ≥40 mmHg, for >15 minutes, if not caused by new-onset arrhythmia, hypovolemia, or sepsis)
• Combined right ventricular dysfunction (RV/LV > 1.0 on imaging) AND troponin concentration above the upper limit of local normal value
• Free floating thrombi in the right atrium or ventricle, if identified by routine echocardiography or CTPA
• Active cancer other than basal or squamous-cell skin cancer defined at least with one of the following: i) cancer diagnosed within the last 6 months, ii) current anti-cancer treatment or during the 6 months before enrollment, iii) locally advanced or metastatic cancer
• PE diagnosis established since more than 24 hours
• 48 hours or more elapsed between ED presentation and potential inclusion or other reason making home discharge impossible within the 48 hours since ED presentation
• Limited life expectancy or any other reason making 3-month follow-up impossible
• Pregnant or parturient patient
• Patient in detention by judicial or administrative decision, under a legal protection measure or undergoing compulsory psychiatric treatment

Where it is running

• 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
• Angers University Hospital, Emergency Department — Angers, France
• Argenteuil hospital, Emergency department — Argenteuil, France

Full record on ClinicalTrials.gov

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