Clinical trial to evaluate the effectiveness and tolerability of fentanyl in continuous infusion versus on demand morphine in patients with heart failure

Phase 1

• Conditions: Refractory dyspnoea in patients hospitalised for acute decompensation of heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-003971-16-ES
• Lead Sponsor: Fundació Assistencial Mútua Terrassa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 18 years or more.
2. Hospitalized at the Hospital Universitari Mútua Terrassa in the internal medicine unit and complex chronic patient unit, due to decompensation of the heart failure, of any etiology. Patients may be included only once in each hospital admission; in case of re-admission for the same reason they may be included again.
3.In optimized treatment of their heart failure decompensation at the discretion of the responsible physician .
4.Persists with refractory dyspnea despite treatment.
5.Patient has received two or more doses of 3mg of subcutaneous morphine on demand for dyspnea in the previous 24 hours, by indication of the responsible physician.
6.The patient gives informed consent attesting to his correct understanding of the purposes and procedures of the study and his willingness to voluntarily participate in the study. In the event that the patient, due to his/her personal conditions or clinical situation, is unable to give consent, the family member or primary caregiver of reference will receive the explanations and give consent.
7.It is expected that the patient will be able to complete the questionnaires on the efficacy and tolerability of the drugs administered. Otherwise, it is expected that the family member or primary caregiver of reference may complete these questionnaires.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 36

Exclusion Criteria

1. History of alcohol or drug abuse
2.Allergy to fentanyl or morphine
3.Contraindication for the use of opioids: 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 states of shock. In case of infection at the injection site and in patients with severe coagulation disorders, administration by epidural or intrathecal route is contraindicated.
4.Concomitant treatment with opioids for other causes.
5.Simultaneous participation in another study or clinical trial.
6.Grade C liver disease (Child-Pugh score > 12.5)
7.Concomitant use of drugs that can alter fentanyl concentrations such as cytochrome P450 3A4 inhibitors and inducers (CYP3A4).
Inhibitors: amiodarone, cimetidine, clarithromycin, diltiazem, erythromycin, fluconazole, itraconazole, ketoconazole, nefazodone, ritonavir, verapamil and voriconazole.
Inducers: carbamazepine, phenobarbital, phenytoin and rifampicin.
8.The risk of mortality in the next 48 hours is considered high.
9.The patient refuses informed consent.
10.The patient is unable to give consent and the family member or primary caregiver referral is unable to give consent or refuses consent.
11.Patients in whom the physician responsible for the patient during his/her hospitalization considers that they should not enter the study, either because they believe that the administration of opioids in continuous perfusion is indicated or contraindicated, or for any other reason. These patients will not be randomized, although they will be asked for informed consent to collect their data, including the various scales that will be passed on to the rest of the patients included.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified