A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

See protocol for complete criteria (page34)
1. Out patients * 18 years of age, male or female.
2. Patients with a diagnosis of chronic heart failure (NYHA Class II * IV):
* LVEF * 35% at visit 1 (local measurement, within the past 6 months).
* Elevated BNP at visit 1: BNP * 150 pg/ml (according to local measurement).
OR BNP * 100 pg/ml (according to local measurement) and unplanned
hospitalization with HF within the last 12 months prior visit 1.
OR
Elevated NT-proBNP at visit 1: BNP * 600 pg/ml (according to local measurement).
OR NT-proBNP * 400 pg/ml (according to local measurement) and unplanned
hospitalization with HF within the last 12 months prior visit 1.;3. Patients must be treated with an ACE inhibitor at a stable dose (enalapril 10 mg
daily at least or any other ACE inhibitor based on equivalent doses described in
Table 4-1: Dose equivalence guidance table of ACEi's) 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 (for patients not
on target dose, according to local guidelines, or in absence of that medication,
the reason should be documented).

Exclusion Criteria

See protocol for complete criteria (page34-36)
2. Patients treated concomitantly with both ARB and aldosterone antagonist in
addition to study drug at visit 1.
4. Symptomatic hypotension and/or less than 95 mmHg SBP at Visit 1 and/ or less
than 90 mmHg SBP at Visits 4.
5. 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.
6. Coronary or carotid artery disease likely to require surgical or percutaneous
intervention within the 6 months after visit 1.
18. Serum potassium * 5.0 mmol/L at Visit 1 or * 5.2 mmol/L at Visit 4.
29. Patients with diabetes mellitus

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objectives of this study are to test if aliskiren monotherapy is<br /><br>superior or at least non-inferior to enalapril monotherapy (in the entire study<br /><br>population) and/or to test if aliskiren/enalapril combination is superior to<br /><br>enalapril monotherapy (in the entire study population and/or in the<br /><br>non-diabetic population), in delaying time to first occurrence of either<br /><br>cardiovascular death or heart failure hospitalization in patients with chronic<br /><br>heart failure (NYHA Class II - IV).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate whether, aliskiren monotherapy and/or the combination of<br /><br>aliskiren/enalapril is superior to enalapril monotherapy in improving the<br /><br>clinical summary score (assessed by KCCQ) from baseline to month 12.</p><br>