Fentanyl for the treatment of dsypnea in patients with chronic heart failure
Phase 1
- Conditions
- Symptomatic treatment of dyspnea induced by chronic heart failureMedDRA version: 9.1Level: LLTClassification code 10013963Term: Dyspnea
- Registration Number
- EUCTR2008-000712-33-AT
- Lead Sponsor
- Medizinische Universität Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
chronic heart failure NYHA IIIb, burden dyspnea, informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
no informed consent, severe organ failures, contraindication for opioids
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Tolerability of buccal fentanyl in patients with acute dyspnea resulted from chronic heart failure;Secondary Objective: <br>Effectiveness of fentanyl in the symptomatic treatment of dyspnea<br>;Primary end point(s): 1. Feasibilty of the study in patients with chronic heart failure NYHA IIIb<br>2. Compliance and tolerabilty of the use of buccal fentanyl in patients with acute dysnpnea<br>3. Effectiveness of buccal fentanyl in patients with acute dyspnea caused by chronic heart failure regarding the time of relieve and the improvement of the physical performance
- Secondary Outcome Measures
Name Time Method