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

Phase 1

• Conditions: Heart Failure; MedDRA version: 19.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-002367-34-DK
• Lead Sponsor: Hjertemedicinsk klinik, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-16
• Last Update Posted: 25 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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
11.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)
12.Unable to give informed consent
13.Reduced compliance
14.All women of child bearing potential will be required to use adequate contraception
15.Pregnant or lactating women
16.Treatment with a tricyclic antidepressant or CYP2D6 substrates other than beta-blockers or treatment with digoxin (only applies to Study A).
For exclusion from the CT part of the study
-Known allergy to iodine containing contrast
-Estimated GFR < 40 ml/min/1.73 m2

Study & Design

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