FENTANYL for Acute decompensated heart failure | Refractory dyspnea

Inclusion criteria

• {"criterion_text":"- 1. Age equal to or greater than 18 years."}
• {"criterion_text":"- 2. Hospitalized at the Mútua Terrassa University Hospital in the internal medicine units and complex chronic patient unit, due to HF decompensation, of any etiology. Patients may be included only once during each hospital admission; In case of re-entry for the same reason, they may be included again."}
• {"criterion_text":"- 3. In optimized treatment of their HF decompensation at the discretion of the specialist doctor responsible for the case."}
• {"criterion_text":"- 4. Refractory dyspnea persists despite treatment."}
• {"criterion_text":"- 5. Has received two or more doses of 3 mg of SC morphine on demand for dyspnea in the previous 24 hours, as indicated by the responsible physician."}
• {"criterion_text":"- 6. The patient gives informed consent that attests to his or her correct understanding of the purposes and procedures of the study and his desire to voluntarily participate in the study. In the event that the patient, due to his or her personal conditions or clinical situation, cannot grant consent, it will be the family member or primary caregiver who receives the explanations and grants consent."}
• {"criterion_text":"- 7. It is expected that the patient will be able to complete questionnaires on the effectiveness and tolerability of the drugs administered. Otherwise, it is expected that the family member or the main reference caregiver will be able to complete these questionnaires."}

Exclusion criteria

• {"criterion_text":"- 1. History of alcohol or drug abuse."}
• {"criterion_text":"- 2. Allergy to fentanyl or morphine"}
• {"criterion_text":"- 3. Contraindication to opioid use: Known hypersensitivity to morphine. Patients with respiratory depression or severe obstructive respiratory disease. Patients with acute bronchial asthma. Patients treated with monoamine oxidase inhibitors or during the 14 days following the suspension of such treatment. Patients with acute and/or severe liver disease. Patients with head injury; increased intracranial pressure. Patients in coma. Patients with spasms of the renal and biliary tract. Patients with acute alcoholism. Patients at risk of paralytic ileus. Patients with ulcerative colitis. Patients in shock. In case of infection at the injection site and in patients with severe coagulation disorders, epidural or intrathecal administration is contraindicated."}
• {"criterion_text":"- 4. Concomitant treatment with opioids for other causes."}
• {"criterion_text":"- 5. Simultaneous participation in another study or clinical trial."}

Primary endpoints

• {"endpoint_text":"- Reduction in the average daily intensity of dyspnea is the main criterion of effectiveness. The intensity of dyspnea is evaluated by the patient himself using a Verbal Numerical Scale (EVN) and a Visual Analogue Scale (VAS) of dyspnea 56. The effectiveness of the treatment is evaluated by comparing the EVN and VAS of dyspnea in the first evaluation or 0h with the EVN and VAS of dyspnea in the following consecutive evaluations or 24h, 48h and 72h.","definition_or_measurement_approach":"Intensity of dyspnea is patient-reported using a Verbal Numerical Scale (EVN) and a Visual Analogue Scale (VAS); effectiveness is assessed by comparing EVN and VAS at baseline (0h) versus 24h, 48h and 72h."}

Spain

Earliest CTIS Part Ii Submission Date

22-01-2025

Latest Decision Or Authorization Date

27-01-2025

Processing Time Days

5

Number Of Sites

1

Number Of Participants

28

Primary sponsor

Full Name

Fundacio Assistencial De Mutua De Terrassa Fpc

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain