Pulmonary Embolism in Patients With Acute Heart Failure: A Pragmatic Cluster-Randomized Trial (PEHF Study)
PEHF
2 other identifiers
interventional
740
1 country
10
Brief Summary
This study focuses on two serious and common medical conditions: heart failure and pulmonary embolism (a blood clot in the lungs). Heart failure happens when the heart cannot pump blood effectively, and it is one of the main reasons older adults are admitted to the hospital. Pulmonary embolism can be life-threatening and may worsen heart failure or even trigger it. Doctors believe that pulmonary embolism may often go undetected in patients who come to the hospital with symptoms of acute heart failure, such as sudden shortness of breath. This is because both conditions can cause similar symptoms, making it difficult to tell them apart. As a result, doctors may sometimes assume the symptoms are only due to heart failure and not investigate further for a possible blood clot. However, missing a pulmonary embolism can have serious consequences. Studies suggest that some patients with heart failure who die may actually have had an undiagnosed pulmonary embolism. Current medical guidelines recommend checking for pulmonary embolism when the cause of breathing problems is unclear, but in real-life practice, this is not always done. The goal of this study is to find out whether pulmonary embolism is underdiagnosed in patients with suspected acute heart failure and whether systematically testing for it could improve patient outcomes. To do this, the study will compare two approaches in several hospitals. In half of the hospitals, doctors will follow their usual practice and decide case by case whether to test for pulmonary embolism. In the other half, doctors will systematically test all eligible patients for pulmonary embolism using recommended diagnostic methods. Adult patients admitted with recent or worsening breathing difficulties and signs of acute heart failure may be included in the study, provided they give their consent. Researchers will collect information about their symptoms, tests, diagnosis, and treatments. Patients will be monitored during their hospital stay and for three months afterward. The study will track important outcomes such as survival, new blood clots, bleeding events, repeated hospital visits for breathing problems, and overall time spent in the hospital. The researchers expect to include about 740 patients in total. They estimate that pulmonary embolism may be found in about 1% of patients with usual care, but up to 5% when doctors systematically look for it. This study aims to better understand how often pulmonary embolism occurs in patients with acute heart failure and whether more systematic testing could lead to earlier diagnosis and better care. The results could help improve medical practice and reduce complications or deaths related to missed diagnoses.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2026
CompletedFirst Posted
Study publicly available on registry
March 30, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
March 30, 2026
March 1, 2026
2 years
March 24, 2026
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of pulmonary embolism
Rate of pulmonary embolism (PE) diagnosed within 48 hours after hospital admission. PE must be objectively confirmed and the diagnosis validated by an independent adjudication committee blinded to study group allocation.
48 hours
Study Arms (2)
Interventional arm
EXPERIMENTALObservational arm
NO INTERVENTIONInterventions
In intervention centers, physicians will systematically screen all patients for pulmonary embolism (PE) using guideline-recommended algorithms. The revised Geneva score will be assessed for each patient. If clinical probability is low or moderate (≤10), highly sensitive D-dimer testing will be performed. PE will be excluded if D-dimer levels are below 500 µg/L (under 50 years) or below the age-adjusted threshold (age × 10 µg/L for patients ≥50 years). For patients with elevated D-dimers or high clinical probability, a 4-point compression venous ultrasound will be performed. If positive, PE will be confirmed. If negative or inconclusive, CT pulmonary angiography will be conducted. All diagnostic procedures must be completed within 48 hours of admission.
Eligibility Criteria
You may qualify if:
- Adult patient (≥18 years)
- Admission to the emergency department or cardiology unit of a participating center
- Recent onset or worsening dyspnea and/or orthopnea
- Diagnosis of acute heart failure defined by recent dyspnea associated with at least one of the following:
- Bilateral pulmonary crackles on auscultation and/or peripheral edema
- Signs of pulmonary congestion on chest X-ray or lung/cardiac ultrasound
- Elevated natriuretic peptide levels (BNP or NT-proBNP)
- Documented history of heart failure (known chronic heart failure or prior hospitalization for acute heart failure)
- Patient affiliated with or beneficiary of a social security system
- Patient able and willing to provide free, informed, and written consent
You may not qualify if:
- Shock state suggesting cardiogenic shock and/or severe pulmonary embolism
- Evidence of acute coronary syndrome on electrocardiogram at admission
- Severe renal impairment (creatinine clearance \<30 mL/min)
- Known hypersensitivity or allergy to iodinated contrast agents
- Ongoing therapeutic anticoagulation for more than 48 hours prior to admission
- Inability to ensure 90-day follow-up (e.g., end-of-life situation, no fixed address, patient not reachable)
- Inadequate understanding of the French language preventing proper study information and consent
- Pregnant, breastfeeding, or postpartum women
- Individuals under legal protection or other vulnerable populations, including minors and protected adults, in accordance with applicable public health regulations (Articles L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Agen Hospital, Emergency department
Agen, 47923, France
Angers University Hospital, Emergency Department
Angers, 49000, France
Brest University Hospital (site Cavale Blanche), Cardiology Department
Brest, 29200, France
Tours University Hospital (site Trousseau), Adult Emergency Department
Chambray-lès-Tours, 37170, France
Cholet Hospital, Emergency Department
Cholet, 49300, France
Clermont-Ferrand University Hospital, Emergency Department
Clermont-Ferrand, 63000, France
Grenoble Alpes University Hospital, Adult Emergency Department
La Tronche, 38700, France
Lyon University Hospital (site Edouard Herriot), Emergency Department
Lyon, 69003, France
Poitiers University Hospital, Emergency Department
Poitiers, 86000, France
Toulouse University Hospital, Emergency Department
Toulouse, 31000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Delphine Douillet, Professor
University Hospital of Angers, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2026
First Posted
March 30, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share