Beta 3 agonist treatment in heart failure (BEAT-HF)

• Conditions: Systolic heart failure; MedDRA version: 14.1Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-004805-29-DK
• Lead Sponsor: The Heart Center, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-28
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

Inclusion criteria
1.Stable heart failure NYHA class II-III on ischemic or non-ischemic basis
2.Left ventricular ejection fraction (LVEF) < 40%
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) no
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Exclusion criteria
1.Unstable cardiac condition
2.Acute myocardial infarction (AMI) or revascularisation < 3 month ago
3.Atrial fibrillation (for technical reasons in relation to imaging and HR reporting)
4.Uncorrected significant primary obstructive valve disease
5.Planned major surgery including cardiac revascularisation
6.Hemodynamically significant obstructive cardiomyopathy
7.Stroke with significant neurological deficit
8.Acute myocarditis or constrictive pericarditis
9.Symptomatic bradycardia or > 1. degree AV-block unless the patient has a pacemaker
10.Clinically significant hepatic (transaminases or bilirubin x 3 above upper reference level) or renal (GFR< 50 ml/min/1,73 m2) diseases
11.Heart failure due to uncorrected thyroid disease
12.Cardiac mechanical support
13.< 6 months after CRT
14.Uncontrolled hypotension (defined as symptomatic systolic blood pressure < 90 mmHg) - or hypertension (defined as systolic at 180 mmHg or above and/or diastolic blood pressure at 110 mmHg or below)
15.Body mass index (BMI) > 35
16.Unable to give informed consent
17.Reduced compliance
18.All women of child bearing potential will be required to use adequate contraception
19.Pregnant or lactating women
20.Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with dig

Study & Design

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