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2024-520025-36-00Not yet recruitingPhase 4

A randomised, double-blind, comparative clinical trial of the effectiveness and tolerability of fentanyl in continuous parenteral perfusion versus on-demand bolus of morphine for the treatment of refractory dyspnoea in patients hospitalised for acute dec

Source: EU CTIS (euclinicaltrials.eu) · Last updated 27 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

To evaluate the effectiveness and tolerability of fentanyl in PCSC, compared with the administration of morphine in BSC on demand, for the treatment of refractory dyspnea in patients hospitalized for acute decompensation of HF.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
28 (estimated)
First submitted
27 Jan 2025
Start date
Mar 2021
Lead sponsor
Fundacio Assistencial De Mutua De Terrassa Fpc
EU CT number
2024-520025-36-00
EudraCT number
2020-003971-16

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 28
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in hospital with worsening heart failure whose breathlessness does not improve with treatment and who needed morphine injections on demand.

Age
18 to 64 years
Sex
All sexes
Disease stage
Hospitalised for worsening (decompensated) heart failure of any cause, on optimised treatment, with breathlessness that persists despite treatment.
Earlier treatment
Must have received two or more doses of 3 mg of morphine under the skin on demand for breathlessness in the previous 24 hours.

Main reasons for not taking part

  • History of alcohol or drug abuse
  • Allergy to fentanyl or morphine
  • Any condition that rules out opioid use, such as severe breathing problems, acute asthma, coma or shock
  • Taking other opioids for other reasons
  • Taking part in another study or clinical trial at the same time

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of alcohol or drug abuse. 2. Allergy to fentanyl or morphine 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. 4. Concomitant treatment with opioids for other causes. 5. Simultaneous participation in another study or clinical trial.

Who the study is looking for

  • Age equal to or greater than 18 years. 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. 3. In optimized treatment of their HF decompensation at the discretion of the specialist doctor responsible for the case. 4. Refractory dyspnea persists despite treatment. 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. 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. 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.

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Fundacio Assistencial De Mutua De Terrassa FpcTerrassaSpainNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.