Study on Fentanyl and Morphine for Treating Severe Shortness of Breath in Heart Failure Patients

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What is this study about?

This clinical trial is focused on studying the treatment of refractory dyspnea, which is a type of severe shortness of breath that does not improve with standard treatments. This condition often affects patients who are hospitalized due to an acute worsening of heart failure. 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.

The purpose of the study is to evaluate how well fentanyl works compared to morphine in relieving the symptoms of refractory dyspnea in patients with heart failure. Participants in the study will receive either continuous doses of fentanyl or on-demand doses of morphine. The study is designed to be double-blind, meaning neither the patients nor the healthcare providers will know which medication is being administered to ensure unbiased results.

Throughout the study, participants will be monitored to assess the reduction in the intensity of their dyspnea. This will be measured using simple scales that the patients can easily understand and use. The study will last for a period of time during which the effectiveness and any side effects of the treatments will be closely observed. The goal is to determine which medication provides better relief for patients suffering from this challenging condition.

1 joining the study

Upon joining the study, the patient is required to provide informed consent. This consent confirms the patient’s understanding of the study’s purposes and procedures.

If the patient is unable to provide consent due to personal or clinical conditions, a family member or primary caregiver will receive the explanations and provide consent on behalf of the patient.

2 initial assessment

The patient undergoes an initial assessment to confirm eligibility. This includes verifying that the patient is hospitalized for heart failure (HF) decompensation and has refractory dyspnea despite treatment.

The patient must have received two or more doses of 3 mg of subcutaneous (SC) morphine on demand for dyspnea in the previous 24 hours.

3 treatment administration

The patient is randomly assigned to receive either fentanyl or morphine. Fentanyl is administered as a continuous intravenous infusion, while morphine is given as an on-demand bolus.

The fentanyl solution for injection is administered intravenously, with a rapid onset of action in less than 30 seconds and a duration of action between 30 and 60 minutes.

4 effectiveness and tolerability evaluation

The effectiveness of the treatment is evaluated by the patient using a Verbal Numerical Scale (EVN) and a Visual Analogue Scale (VAS) to measure the intensity of dyspnea.

These evaluations occur at the initial assessment (0 hours) and are repeated at 24, 48, and 72 hours to monitor changes in dyspnea intensity.

5 completion of questionnaires

The patient is expected to complete questionnaires regarding the effectiveness and tolerability of the administered drugs.

If the patient is unable to complete the questionnaires, a family member or primary caregiver is expected to do so.

Who Can Join the Study?

  • The patient must be 18 years old or older.
  • The patient must be hospitalized at the Mútua Terrassa University Hospital in the internal medicine units or complex chronic patient unit due to heart failure (HF) decompensation. This means their heart condition has worsened.
  • The patient must be receiving the best possible treatment for their heart failure, as decided by their doctor.
  • The patient must have refractory dyspnea, which means they have trouble breathing that doesn’t get better with treatment.
  • The patient must have received two or more doses of 3 mg of morphine under the skin for breathing problems in the last 24 hours, as directed by their doctor.
  • The patient must give informed consent, which means they understand the study and agree to participate. If the patient can’t give consent, a family member or main caregiver can do it for them.
  • The patient or their family member/caregiver must be able to complete questionnaires about how well the drugs work and how they feel after taking them.

Who Cannot Join the Study?

  • Patients who are not experiencing refractory dyspnea. This means patients who do not have severe difficulty breathing that does not improve with standard treatments.
  • Patients who are not hospitalized for acute decompensation of HF. This refers to patients who are not in the hospital due to a sudden worsening of heart failure symptoms.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population. This means individuals who may need special protection or care, such as children or those unable to make decisions for themselves.
  • Patients who are not eligible based on other specific criteria set by the study, which are not detailed here.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
02.03.2021

Trial locations

Investigated drugs:

Fentanyl is a strong pain medication used in this trial to help manage severe breathing difficulties in patients. It is given continuously through a method called parenteral perfusion, which means it is delivered directly into the bloodstream to provide a steady effect.

Morphine is another powerful pain medication used in this trial. It is given to patients as needed, in doses that are administered when the patient experiences severe breathing problems. This method is known as on-demand bolus administration.

Investigated diseases:

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively, leading to insufficient blood flow to meet the body’s needs. It can develop gradually or suddenly and is often characterized by symptoms such as shortness of breath, fatigue, and fluid retention. Over time, the heart’s ability to function properly may worsen, causing more severe symptoms. The condition can affect either the left side, right side, or both sides of the heart. It often results from other underlying health issues, such as coronary artery disease or high blood pressure. Management focuses on improving symptoms and quality of life.

Trial ID:
2024-520025-36-00
Protocol code:
ESTUDIO FEMODRIC
Trial Phase:
Human Pharmacology (Phase I) – Other

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