In short
Currently, there is 1 ongoing clinical trial investigating treatments for severe shortness of breath that does not respond to standard therapies. This trial is being conducted in Spain and focuses on comparing two medications—fentanyl and morphine—in patients hospitalized with worsening heart failure.
Clinical trial locations
- Spain
Study on Fentanyl and Morphine for Treating Severe Shortness of Breath in Heart Failure Patients
This clinical trial is investigating treatment options for refractory dyspnea, which is severe shortness of breath that does not improve with standard treatments. The condition often affects patients who are hospitalized due to an acute worsening of heart failure. The study is being conducted at Mútua Terrassa University Hospital in Spain.
Main inclusion criteria:
- Patients must be 18 years old or older
- Must be hospitalized due to heart failure decompensation (worsening of heart condition)
- Must be receiving the best possible treatment for heart failure as determined by their doctor
- Must have refractory dyspnea (trouble breathing that doesn't improve with treatment)
- Must have received two or more doses of 3 mg of morphine under the skin for breathing problems in the last 24 hours
- Must provide informed consent, or have a family member or caregiver provide consent if unable to do so
- Must be able to complete questionnaires about treatment effectiveness, either personally or through a family member or caregiver
Main exclusion criteria:
- Patients who are not experiencing refractory dyspnea
- Patients who are not hospitalized for acute decompensation of heart failure
- Patients who are not within the specified age range
- Patients who belong to a vulnerable population requiring special protection
Focus and goal of the trial:
The study aims to compare the effectiveness and tolerability of two medications: fentanyl and morphine. Fentanyl is a powerful pain-relieving medication that works quickly when given intravenously, while morphine is another well-known pain reliever often used in hospitals. Participants will receive either continuous doses of fentanyl delivered directly into the bloodstream or on-demand doses of morphine given as needed.
The study is designed as a double-blind trial, meaning neither patients nor healthcare providers will know which medication is being administered, ensuring unbiased results. Throughout the study, participants will be monitored to assess the reduction in the intensity of their breathing difficulties using simple scales at initial assessment and at 24, 48, and 72 hours. The goal is to determine which medication provides better relief for patients suffering from this challenging condition.
Investigational drugs:
The trial is testing two medications:
- Fentanyl: A strong pain medication administered continuously through an intravenous infusion. It works very quickly, with effects beginning in less than 30 seconds and lasting between 30 and 60 minutes. It is a synthetic opioid that works by binding to opioid receptors in the brain, altering the perception of pain and providing relief.
- Morphine: Another powerful pain medication given to patients as needed in doses administered when severe breathing problems occur. This is known as on-demand bolus administration.
Summary
Currently, there is one active clinical trial focused on treating severe shortness of breath in patients with heart failure. This trial is taking place in Spain and is comparing two opioid medications—fentanyl and morphine—to determine which provides better relief for refractory dyspnea. The study uses a rigorous double-blind design to ensure objective results and monitors patients over a 72-hour period using patient-reported measures of breathing difficulty. This research is important for patients who continue to experience severe breathing problems despite receiving standard heart failure treatments.
