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Clinical Trials/EUCTR2016-002367-34-DK
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.

Registry
who.int
Start Date
June 16, 2016
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hjertemedicinsk klinik, Rigshospitalet

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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