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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01040494
Eligibility Criteria:
Inclusion Criteria:
1. Outpatients ≥ 18 years of age, male or female. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
2. Patients with a diagnosis of chronic heart failure (NYHA Class II-IV) and reduced systolic function: LVEF ≤ 45% at Visit 1 (local measurement, measured within the past 6 months assessed by echocardiogram, MUGA, CT scan, MRI or ventricular angiography).
3. Patients must be on a stable dose of either an ACE inhibitor or an ARB for at least 4 weeks prior to Visit 1.
4. Patients must be treated with a beta blocker, unless contraindicated or not tolerated, at a stable dose for at least 4 weeks prior to Visit 1.
5. Patients with documented sinus rhythm at Visit 1.
Exclusion Criteria:
1. History of hypersensitivity to any of the study drugs.
2. Patients who require treatment with both ACEI and ARB.
3. Current acute decompensated HF (exacerbation of chronic HF manifested by signs \& symptoms that may require IV therapy).
4. Symptomatic hypotension and/or less than 100 mmHg at the time of screening or less than 90 mmHg at the time of randomization.
5. eGFR \< 30 ml/min/1.73m2 as measured by the MDRD formula at Visit 1 (screening) , or a \> 25% decrease after 14 days of active run-in period.
6. Serum potassium \> 5.0 mmol/L at screening (Visit 1).
7. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or major vascular surgery, percutaneous coronary intervention (PCI) or carotid angioplasty, within the past 3 months prior to visit 1.
8. Coronary or carotid artery disease likely to require surgical or percutaneous intervention within the 6 months after Visit 1.
9. Patients with active or unstable bronchospasm or asthma (patients must be on stable regimen of respiratory medications for 1 month prior to Visit 1).
10. Right heart failure due to severe pulmonary disease.
11. Diagnosis of peripartum or chemotherapy induced cardiomyopathy within the 12 months prior to visit 1.
12. Patients with a history of heart transplant or who are on a transplant list or with left ventricular assistance device (LVAD device).
13. Documented ventricular arrhythmia with syncopal episodes within past 3 months, prior to visit 1, that is untreated.
14. Symptomatic bradycardia or second or third degree heart block without a pacemaker.
15. Implantation of a CRT (cardiac resynchronization therapy) device within the prior 3 months from visit 1 or intent to implant a CRT device.
16. Presence of hemodynamically significant mitral and/or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation.
17. Presence of other hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic and sub-aortic stenosis.
18. Severe primary pulmonary, renal or hepatic disease.
19. Presence of any other disease with a life expectancy of \< 1 year.
20. Chronic long-term requirement for NSAIDs (high dose) or COX2 inhibitors, with the exception of aspirin at doses used for CV prophylaxis (≤325 mg o.d.).
21. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs
22. Subjects are now breast feeding, get pregnant or will be pregnant within 6 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01040494
Study Brief:
Protocol Section:
NCT01040494