EUCTR2016-002367-34-DK
Active, not recruiting
Phase 1
Beta 3 agonist treatment in heart failure (BEAT-HF II) - BEAT-HF II
Hjertemedicinsk klinik, Rigshospitalet0 sites70 target enrollmentJune 16, 2016
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Hjertemedicinsk klinik, Rigshospitalet
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Stable heart failure NYHA class II\-III on ischemic or non\-ischemic basis
- •2\.Left ventricular ejection fraction (LVEF) \< 35% as assessed by cardiac CT
- •3\.Stable sinus rhythm (SR)
- •4\.On optimised evidence\-based pharmacological HF treatment stable \> 4 weeks with no current plan for changing HF therapy. The therapy must include a beta\-blocker.
- •5\.No change in diuretics \<4 weeks
- •6\.\>18 years
- •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 40
Exclusion Criteria
- •1\.Acute myocardial infarction (AMI) or revascularisation \< 3 month ago
- •2\.Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
- •3\.Uncorrected significant primary obstructive valve disease
- •4\.Planned major surgery including cardiac revascularisation
- •5\.Hemodynamically significant obstructive cardiomyopathy
- •6\.Acute myocarditis or constrictive pericarditis
- •7\.Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR\< 40 ml/min/1,73 m2\) diseases
- •8\.Heart failure due to uncorrected thyroid disease
- •9\.Cardiac mechanical support
- •10\.\< 6 months after CRT
Outcomes
Primary Outcomes
Not specified
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