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 (HOME-PE2)

March 26, 2026 updated by: University Hospital, Angers

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

PE is a common and potentially life-threatening condition with a wide spectrum of clinical severity. In recent years, outpatient management has been demonstrated to be safe and effective in selected low-risk patients, particularly those without hemodynamic instability or significant comorbidities. Risk stratification tools such as the Hestia rule are widely used to identify patients eligible for home treatment based on clinical criteria.

However, uncertainty remains regarding the optimal management of patients who, despite having no clinical severity criteria according to the Hestia rule, present signs of right ventricular dysfunction (RVD) on imaging or elevated cardiac troponin levels. These markers are associated with an increased risk of adverse outcomes in some populations and are used in certain guidelines to classify patients as intermediate risk, often leading to hospitalization. In contrast, other recommendations do not require systematic cardiac assessment in clinically stable patients and support outpatient care in the absence of clinical severity criteria. As a result, clinical practice remains heterogeneous, and hospitalization is still frequently preferred in this subgroup despite limited prospective evidence.

The HOME-PE2 study is designed to address this gap by comparing two commonly used management strategies-home treatment and hospitalization-in this specific population. The trial aims to determine whether outpatient management is non-inferior to hospitalization in terms of short-term safety, while also evaluating broader patient-centered and health system outcomes.

HOME-PE2 is an international, multicenter, open-label, randomized controlled trial with blinded adjudication of clinical outcomes. Eligible adult patients presenting to the emergency department with objectively confirmed acute PE will be assessed for clinical severity using the Hestia rule. Patients without clinical criteria requiring hospitalization but with either RVD on imaging or elevated cardiac troponin levels will be randomized in a 1:1 ratio to either home treatment or hospitalization. Randomization will be stratified by country and by the qualifying cardiac abnormality.

Patients allocated to the home treatment group will be discharged early after inclusion, according to predefined timelines consistent with outpatient management. Patients assigned to the hospitalization group will receive standard inpatient care according to local practice. In both groups, anticoagulant therapy will be initiated and managed according to current guidelines and local protocols.

The study incorporates pragmatic features, including the comparison of usual care management strategies and flexibility in anticoagulation treatment according to local practice, thereby enhancing the generalizability of the findings to real-world clinical settings.

All patients will receive structured follow-up over a 90-day period. Clinical follow-up will include scheduled assessments shortly after inclusion and at later time points, either through in-person visits aligned with routine care or via telephone contact. In addition, patient-reported outcomes will be collected longitudinally using validated instruments assessing health-related quality of life and functional status. Data on healthcare utilization, including hospital readmissions and length of stay, will also be collected.

An independent clinical events committee, blinded to treatment allocation, will adjudicate all suspected outcome events based on predefined criteria to ensure consistency and reliability of endpoint assessment.

Beyond safety, the study will evaluate the overall net clinical benefit of home treatment compared with hospitalization, integrating multiple clinically relevant outcomes in a hierarchical framework. It will also assess the impact of management strategy on patient-reported outcomes, including quality of life and functional recovery, as well as healthcare resource use.

In addition, exploratory analyses will examine the influence of sex and living conditions on outcomes, in order to better understand potential differences in the feasibility and impact of outpatient care. A health-economic evaluation will be conducted to compare cost-utility and to estimate the potential budget impact of implementing outpatient management strategies in this population.

By rigorously comparing home treatment and hospitalization in patients with acute PE without clinical severity but with cardiac involvement, the HOME-PE2 trial aims to generate high-quality evidence to inform clinical guidelines, improve patient-centered care, and optimize the use of healthcare resources.

Study Type

Interventional

Enrollment (Estimated)

568

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Pierre-Marie ROY, Professor
  • Phone Number: + 33 (0)2 41 35 37 18
  • Email: PMRoy@chu-angers.fr

Study Locations

  • France
      • Angers, France, 49000
        • Angers University Hospital, Emergency Department
        • Contact:
      • Argenteuil, France, 95100
      • Brest, France, 29200
        • Brest University Hospital (site Cavale Blanche), Cardiology Department
        • Contact:
      • Cholet, France, 49300
      • Clermont-Ferrand, France, 63000
        • Clermont-Ferrand University Hospital, Emergency Department
        • Contact:
      • Colombes, France
        • Paris University Hospital (APHP - site Louis Mourier), Emergency Department
        • Contact:
      • Grenoble, France, 38000
        • Grenoble University Hospital, Emergency Department
        • Contact:
      • Le Mans, France, 72000
        • Le Mans Hospital, Emergency department
        • Contact:
      • Lyon, France, 69003
        • Lyon University Hospital (site Edouard Herriot), Emergency Department
        • Contact:
      • Nantes, France, 44000
      • Paris, France, 75010
        • Paris University Hospital (APHP - site Lariboisière hospital), emergency department
        • Contact:
      • Paris, France, 75013
        • Paris University Hospital (APHP - site La Pitié-Salpétrière Hospital), Emergency Department
        • Contact:
      • Paris, France, 75015
        • Paris University Hospital (APHP - site HEGP), Emergency Department
        • Contact:
      • Paris, France
      • Pierre-Bénite, France, 69495
        • Lyon University Hospital (site Lyon Sud), Emergency department
        • Contact:
      • Poitiers, France, 86000
      • Rouen, France, 76000
        • Rouen University Hospital, Emergency Department
        • Contact:
      • Toulouse, France, 31000
        • Toulouse University Hospital, Emergency Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home treatment
Patients randomized to this arm are managed as outpatients and discharged early after inclusion, no later than 24 hours after inclusion and no later than 48 hours after presentation to the emergency department. Anticoagulation therapy is initiated prior to discharge and continued in accordance with current guidelines and local practice. Patients receive structured follow-up in accordance with current guidelines and are instructed to seek medical attention in case of clinical deterioration, suspected recurrence of venous thromboembolism, or bleeding.
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.
Active Comparator: Hospitalization
Patients randomized to this arm are managed as inpatients and admitted to a hospital medical unit for the management of acute PE according to local organization. Anticoagulation therapy is initiated and managed in accordance with current guidelines and local practice. The duration of hospitalization and timing of discharge are left to the discretion of the treating physician. Patients receive structured follow-up in accordance with current guidelines and are instructed to seek medical attention in case of clinical deterioration, suspected recurrence of venous thromboembolism, or bleeding.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
7-day composite incidence of adverse events (EARTH criteria)
Time Frame: Within 7 days following randomization
Composite outcome defined according to the EARTH consensus, including the occurrence of any of the following events within 7 days after randomization: death possibly or confirmed to be related to pulmonary embolism (including death of undetermined cause), hemodynamic failure, respiratory failure, cardiac rhythm disorders requiring urgent treatment, major bleeding (according to ISTH definition), or recurrent venous thromboembolism (symptomatic pulmonary embolism or proximal deep vein thrombosis requiring treatment or modification of anticoagulation). All outcome events are adjudicated by an independent clinical events committee blinded to treatment allocation.
Within 7 days following randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Net benefit at 7 days (hierarchical composite outcome)
Time Frame: Within 7 days following randomization
Hierarchical composite outcome assessed using a win-ratio approach, including the following components in order of priority: death possibly or confirmed to be related to pulmonary embolism (including death of undetermined cause), hemodynamic failure, respiratory failure, cardiac rhythm disorders requiring urgent treatment, major bleeding (ISTH definition), recurrent venous thromboembolism (symptomatic pulmonary embolism or proximal deep vein thrombosis requiring treatment or modification of anticoagulation), non-major clinically relevant bleeding, unscheduled hospital presentations (all causes), and cumulative length of hospital stay.
Within 7 days following randomization
Global health quality-of-life (short term)
Time Frame: Baseline (Day 0), Day 3, Day 7
Change over time in health-related quality of life assessed using the EQ-5D-5L questionnaire.
Baseline (Day 0), Day 3, Day 7
Functional status (short term)
Time Frame: Pre-pulmonary embolism status estimated at inclusion, Day 0, Day 3, and Day 7
Change over time in patient-reported functional status assessed using the Post-VTE Functional Status (PVFS) scale.
Pre-pulmonary embolism status estimated at inclusion, Day 0, Day 3, and Day 7
Composite incidence of major adverse events
Time Frame: Within 14 days, 30 days, and 90 days following randomization
Composite of all cause-death, recurrent venous thromboembolism and major bleeding
Within 14 days, 30 days, and 90 days following randomization
Individual components of safety outcomes
Time Frame: Within 14 days, 30 days, and 90 days following randomization
Incidence of all cause-death, recurrent venous thromboembolism, major bleeding, non-major clinically relevant bleeding, pulmonary embolism -related mortality and fatal bleeding.
Within 14 days, 30 days, and 90 days following randomization
Health-related quality of life
Time Frame: Baseline (Day 0), Days 3, 7, 14, 30, and 90
Longitudinal assessment of EQ-5D-5L scores over 90 days
Baseline (Day 0), Days 3, 7, 14, 30, and 90
Functional status
Time Frame: Pre-pulmonary embolism status estimated at inclusion, Day 0 and Days 3, 7, 14, 30 and 90
Longitudinal assessment of the Post-VTE Functional Status (PVFS) over 90 days
Pre-pulmonary embolism status estimated at inclusion, Day 0 and Days 3, 7, 14, 30 and 90
Hospital resources utilization
Time Frame: Within 14 days, 30 days, and 90 days following inclusion
Number of unscheduled hospital presentations and cumulative lenght of in-hospital stay
Within 14 days, 30 days, and 90 days following inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Pierre-Marie ROY, Professor, University Hospital of Angers, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Hendriks SV, Klok FA, den Exter PL, et al. Right Ventricle-to-Left Ventricle Diameter Ratio Measurement Seems to Have No Role in Low-Risk Patients with Pulmonary Embolism Treated at Home Triaged by Hestia Criteria. Am J Respir Crit Care Med 2020; 202(1): 138-41.
  • Sanchez O, Benhamou Y, Bertoletti L, et al. [Recommendations of good practice for the management of thromboembolic venous disease in adults. Short version]. Rev Mal Respir 2019; 36(2): 249-83.
  • Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J 2020; 41(4): 543-603.
  • Zondag W, Mos IC, Creemers-Schild D, et al. Outpatient treatment in patients with acute pulmonary embolism: the Hestia Study. J Thromb Haemost 2011; 9(8): 1500-7.
  • Roy PM, Penaloza A, Hugli O, et al. Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial. Eur Heart J 2021; 42(33): 3146-57.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

March 26, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

April 1, 2026

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC24_0325
  • 2026-A00754-47 (Other Identifier: French Ministry of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) collected during the study and relevant to the analyses will be made available after completion of the study to qualified researchers upon reasonable request to the coordinating investigator, subject to approval by the steering committee and in accordance with applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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