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:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT01554592
Eligibility Criteria:
Inclusion Criteria:
1. Over the age of 18 years
2. Documented heart failure of ischaemic, idiopathic or hypertensive cause
3. New York Heart Association (NYHA) class II, III or IV symptoms
4. LVEF \< 0.40, or no more than 0.35 if NYHA class II and ischaemic aetiology.
5. Receiving ACE inhibitor or ARB (Angiotensin II Receptor Blockers), β-blocker and diuretic therapy at the optimal doses.
6. Has been receiving statin therapy for at least 3 months
7. Willing and able to provide informed consent
Exclusion Criteria:
1. Treatment with statins primarily for treatment of hypercholesterolaemia
2. Obstructive or restrictive cardiomyopathy
3. Uncorrected primary valvular disease
4. Active myocarditis
5. Decompensated heart failure or a need for inotropic therapy
6. Myocardial infarction within the past 6 months
7. Unstable angina or stroke within the past 3 months
8. PCI (Percutaneous coronary intervention), CABG (coronary artery bypass graft)or implantation of cardioverter-defibrillator or biventricular pacemaker within the past 3 months or a planned implantation of such a device
9. Previous or planned cardiac transplantation
10. Pericardial disease or systemic disease (eg amyloidosis)
11. Acute or chronic liver disease
12. Alanine and aspartate transminase concentrations more than 1.5 times the upper limit of normal
13. Chronic muscle disease or an unexplained creatinine kinase level of more than 2.5 times the upper limit of normal
14. Serum creatinine level greater than 221 micromol/L
15. Previous treatment with cyclosporine
16. Exercise capacity limited by factors other than cardiac dyspnoea
17. Hospitalisation within one month of randomisation
18. Pregnant or lactating women or women of childbearing potential who were not adequately protected against becoming pregnant
19. Any other concurrent condition that, in the opinion of the investigator, would prevent completion of the clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01554592
Study Brief:
Protocol Section:
NCT01554592