Pulmonary Embolism in Patients With Acute Heart Failure (PEHF Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patient (≥18 years)
Admission to the emergency department or cardiology unit of a participating center
Recent onset or worsening dyspnea and/or orthopnea
Bilateral pulmonary crackles on auscultation and/or peripheral edema
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Systematic screening for pulmonary embolism in all patients using a guideline-recommended diagnostic algorithm
Diagnostic testIn 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.
Treatment groups
740 Participants
are divided into 2 treatment groupsGroup A: Interventional armExperimental treatment 1 intervention
Group B: Observational armNo intervention 0 interventions
Trial outcomes
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.
Time frame
48 hoursSponsors and contacts
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Source ClinicalTrials.gov