Pulmonary Embolism in Patients With Acute Heart Failure (PEHF Study) (NCT07499661) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pulmonary Embolism in Patients With Acute Heart Failure (PEHF Study)
France740 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is specifically looking at patients with acute heart failure who may also have pulmonary embolism — given my diagnosis, does my doctor think I could have both conditions at the same time, and would being in this study help clarify that?
2Since this trial is not yet recruiting, how long might it realistically be before enrollment opens, and is there a standard diagnostic approach my care team would use in the meantime to check for pulmonary embolism alongside my heart failure?
3This study is listed as Phase NA, which suggests it's observational or diagnostic rather than testing a new treatment — does that mean participating would involve extra tests or imaging beyond what I'd normally receive, and what would those involve?
4The trial is measuring the rate of pulmonary embolism in people with acute heart failure — if it turns out I do have a pulmonary embolism, how would my treatment plan change, and would being in this study affect when or how I'd start getting treated?
5Are there any risks to the additional diagnostic evaluations this study might require, especially given that I'm already dealing with acute heart failure, and would my doctor recommend I wait for standard care options instead of waiting for this trial to open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.