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ClinicalTrials.gov ID

NCT07506291

Lead Sponsor

University Hospital, AngersOTHER_GOV

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

568Estimated

Last Update Posted

Apr 1, 2026Actual

Start Date

Jun 2026Estimated

Primary Completion Date

Jun 2029Estimated

Completion Date

Sep 2029Estimated

Official Title

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

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.

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.

• Acute Pulmonary Embolism

• Home treatment
• Hospitalization

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, AngersOTHER_GOV

caroline.soulie-chavignon@ch-cholet.fr0241496985

cyrielle.houalard@gmail.com0243434343