Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT01876433
Eligibility 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
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 digoxin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01876433
Study Brief:
Protocol Section:
NCT01876433