Pulmonary Embolism in Patients With Acute Heart Failure (PEHF Study) (PEHF)

March 30, 2026 updated by: University Hospital, Angers

Pulmonary Embolism in Patients With Acute Heart Failure: A Pragmatic Cluster-Randomized Trial (PEHF Study)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

740

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

Study Locations

  • France
      • Agen, France, 47923
        • Agen Hospital, Emergency department
        • Contact:
      • Angers, France, 49000
        • Angers University Hospital, Emergency Department
        • Contact:
      • Brest, France, 29200
        • Brest University Hospital (site Cavale Blanche), Cardiology Department
        • Contact:
      • Chambray-lès-Tours, France, 37170
        • Tours University Hospital (site Trousseau), Adult Emergency Department
        • Contact:
      • Cholet, France, 49300
        • Cholet Hospital, Emergency Department
        • Contact:
      • Clermont-Ferrand, France, 63000
        • Clermont-Ferrand University Hospital, Emergency Department
        • Contact:
      • La Tronche, France, 38700
        • Grenoble Alpes University Hospital, Adult Emergency Department
        • Contact:
      • Lyon, France, 69003
        • Lyon University Hospital (site Edouard Herriot), Emergency Department
        • Contact:
      • Poitiers, France, 86000
      • 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:

  • 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

Exclusion Criteria:

  • Shock state suggesting cardiogenic shock and/or severe pulmonary embolism
  • Severe respiratory distress at inclusion preventing appropriate positioning or performance of imaging examinations
  • 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
  • Hospitalization for more than 48 hours prior to inclusion
  • 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)

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional arm
Diagnostic test: Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithm

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.
No Intervention: Observational arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pulmonary embolism
Time Frame: 48 hours
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

Collaborators and Investigators

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

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Delphine Douillet, Professor, University Hospital of Angers, France

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, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC25_0434
  • 2025-A02492-47 (Other Identifier: ID-RCB (French Ministry of Health))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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