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

NCT07506291 | Not Yet Recruiting

• 2 other identifiers: 49RC24_03252026-A00754-47
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 18

Brief 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.

Conditions

Acute Pulmonary Embolism

Keywords

pulmonary embolism; Outpatient treatment; Home treatment; Hospitalization; Hestia rule; Right ventricular dysfunction; Troponin; Risk stratification; Randomized controlled trial; Quality of life; Functional status; Health economics

Outcome Measures

Primary Outcomes (1)

• 7-day composite incidence of adverse events (EARTH criteria)

  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 Outcomes (8)

• Net benefit at 7 days (hierarchical composite outcome)

  Within 7 days following randomization

• Global health quality-of-life (short term)

  Baseline (Day 0), Day 3, Day 7

• Functional status (short term)

  Pre-pulmonary embolism status estimated at inclusion, Day 0, Day 3, and Day 7

• Composite incidence of major adverse events

  Within 14 days, 30 days, and 90 days following randomization

• Individual components of safety outcomes

  Within 14 days, 30 days, and 90 days following randomization

Study Arms (2)

Home treatment

EXPERIMENTAL

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

Hospitalization

ACTIVE COMPARATOR

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

Interventions

Home treatment OTHER

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.

Home treatment

Hospitalization OTHER

Inpatient management strategy for acute pulmonary embolism, including hospital admission and standard care with anticoagulation therapy according to current guidelines and local practice.

Hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (18)

Angers University Hospital, Emergency Department

Angers, 49000, France

Location

Argenteuil hospital, Emergency department

Argenteuil, 95100, France

Location

Brest University Hospital (site Cavale Blanche), Cardiology Department

Brest, 29200, France

Location

Cholet Hospital, Emergency department

Cholet, 49300, France

Location

Clermont-Ferrand University Hospital, Emergency department

Clermont-Ferrand, 63000, France

Location

Paris University Hospital (APHP - site Louis Mourier), Emergency Department

Colombes, France

Location

Grenoble University Hospital, Emergency Department

Grenoble, 38000, France

Location

Le Mans Hospital, Emergency department

Le Mans, 72000, France

Location

Lyon University Hospital (site Edouard Herriot), Emergency Department

Lyon, 69003, France

Location

Nantes University Hospital, Emergency department

Nantes, 44000, France

Location

Paris University Hospital (APHP - site Lariboisière hospital), emergency department

Paris, 75010, France

Location

Paris University Hospital (APHP - site La Pitié-Salpétrière Hospital), Emergency Department

Paris, 75013, France

Location

Paris University Hospital (APHP - site HEGP), Emergency Department

Paris, 75015, France

Location

Paris University Hospital (APHP, site Hôpital Européen Georges Pompidou), Pneumology department

Paris, France

Location

Lyon University Hospital (site Lyon Sud), Emergency department

Pierre-Bénite, 69495, France

Location

Poitiers University Hospital, Emergency Department

Poitiers, 86000, France

Location

Rouen University Hospital, Emergency Department

Rouen, 76000, France

Location

Toulouse University Hospital, Emergency Department

Toulouse, 31000, France

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Ventricular Dysfunction, Right

Interventions

Hospitalization

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pierre-Marie ROY, Professor

  University Hospital of Angers, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Marie ROY, Professor

CONTACT

+ 33 (0)2 41 35 37 18; PMRoy@chu-angers.fr

Matthieu LE LAY

CONTACT

+33 (0)2 41 35 58 91; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study follows a PROBE (Prospective Randomized Open, Blinded Endpoint) design. Due to the nature of the interventions, participants and treating physicians are not blinded to treatment allocation (home treatment versus hospitalization). However, all suspected outcome events are centrally adjudicated by an independent clinical events committee blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a multicenter, international, randomized, open-label, parallel-group trial comparing two management strategies in patients with acute pulmonary embolism without clinical severity criteria but with either right ventricular dysfunction or elevated cardiac troponin levels. Eligible patients are randomized in a 1:1 ratio to either home treatment with early discharge or standard hospitalization. Randomization is stratified by country and by the type of cardiac abnormality (right ventricular dysfunction or elevated troponin). All patients receive anticoagulation therapy according to current guidelines and local practice. Clinical outcomes are assessed during a 90-day follow-up period, with blinded adjudication of all outcome events.

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (18)