An interventional study of Home treatment and Hospitalization in Acute Pulmonary Embolism, sponsored by University Hospital, Angers. Not yet recruiting at 18 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by University Hospital, Angers · Not applicable, Interventional, and Treatment
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.
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.
832 studies on the registry are indexed under Pulmonary Embolism; 171 are open to participants now.
This study's planned enrollment of 568 is above the median of 174 across 429 interventional studies indexed under Pulmonary Embolism.
Browse Pulmonary Embolism studies →University Hospital, Angers is the lead sponsor of 478 studies on the registry; 120 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Inpatient management strategy for acute pulmonary embolism, including hospital admission and standard care with anticoagulation therapy according to current guidelines and local practice.
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.
Time frame: Within 7 days following randomization
Net benefit at 7 days (hierarchical composite outcome)
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.
Time frame: Within 7 days following randomization
Global health quality-of-life (short term)
Change over time in health-related quality of life assessed using the EQ-5D-5L questionnaire.
Time frame: Baseline (Day 0), Day 3, Day 7
Functional status (short term)
Change over time in patient-reported functional status assessed using the Post-VTE Functional Status (PVFS) scale.
Time frame: Pre-pulmonary embolism status estimated at inclusion, Day 0, Day 3, and Day 7
Composite incidence of major adverse events
Composite of all cause-death, recurrent venous thromboembolism and major bleeding
Time frame: Within 14 days, 30 days, and 90 days following randomization
Individual components of safety outcomes
Incidence of all cause-death, recurrent venous thromboembolism, major bleeding, non-major clinically relevant bleeding, pulmonary embolism -related mortality and fatal bleeding.
Time frame: Within 14 days, 30 days, and 90 days following randomization
Health-related quality of life
Longitudinal assessment of EQ-5D-5L scores over 90 days
Time frame: Baseline (Day 0), Days 3, 7, 14, 30, and 90
Functional status
Longitudinal assessment of the Post-VTE Functional Status (PVFS) over 90 days
Time frame: Pre-pulmonary embolism status estimated at inclusion, Day 0 and Days 3, 7, 14, 30 and 90
Hospital resources utilization
Number of unscheduled hospital presentations and cumulative lenght of in-hospital stay
Time frame: Within 14 days, 30 days, and 90 days following inclusion
Plan to share: Yes — 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.
Start is estimated for Jun 2026; primary completion for Jun 2029, 36 months later.
Of 125 non-industry interventional studies with no phase under Pulmonary Embolism, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 55. This study's planned 36 months is above that.
Counting every sponsor, half of 150 studies reached it within 25 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.