Screening for blood clots in adults with acute heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses a cluster-randomized design to implement a systematic, guideline-driven diagnostic algorithm for pulmonary embolism in patients with acute heart failure. Eligible patients are adults admitted with new or worsening dyspnea and signs of heart failure, and centers are assigned to apply the screening protocol. The goal is to see if routine testing for embolism improves detection without causing undue delays or harms. Outcomes focus on embolism detection rates, diagnostic timelines, and safety. The trial is conducted across multiple hospitals in France.

Why it matters

Who can join: the full rules

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)

Where it's running

• Angers University Hospital, Emergency Department
  Angers, France Recruiting
• Agen Hospital, Emergency department
  Agen, France Not yet recruiting
• Brest University Hospital (site Cavale Blanche), Cardiology Department
  Brest, France Not yet recruiting
• Tours University Hospital (site Trousseau), Adult Emergency Department
  Chambray-lès-Tours, France Not yet recruiting
• Cholet Hospital, Emergency Department
  Cholet, France Not yet recruiting
• Clermont-Ferrand University Hospital, Emergency Department
  Clermont-Ferrand, France Not yet recruiting

Study contacts

• Principal investigator: Delphine Douillet, Professor — University Hospital of Angers, France
• Study coordinator: Delphine Douillet, Professor
• Email: Delphine.Douillet@chu-angers.fr
• Phone: +33 (0)2 41 35 36 27

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.