Hypertension
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Outpatients 18 years of age and older. • Male or female patients are eligible. 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. • Patients with history or current diagnosis of essential hypertension • Patients with stable heart failure (NYHA Class II-IV), for at least 1 month prior to Visit 1. Patients must be on a stable dosage regimen of heart failure medications which may consist of the following: either an ACE inhibitor OR an ARB, and a beta blocker for the 1 month period prior to Visit 1. For patients not on either an ACE inhibitor OR an ARB, and a beta blocker at entry the reason (e.g., patient is intolerant of these medications or the absence of a clinical indication) should be documented. The use of digoxin and diuretics as background therapy for heart failure is allowed. Patients may be randomised as soon as clinically possible following a hospitalisation for heart failure, if their dosage regmien of heart failure mediciation (i.e. ACE inhibitor OR an ARB, and a beta blocker) have been stable for 1 month prior to Visit 1. • Patients with a BNP > 100 pg/ml (28.9 pmol/L) at Visit 1. • Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent). 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with stable heart failure who require treatment with both an ACE inhibitor and an ARB • Patients who previously entered an aliskiren study and who qualified to be randomized or enrolled into the active drug treatment period. • History or evidence of a secondary form of hypertension • Right heart failure due to pulmonary disease. • Diagnosis of postpartum cardiomyopathy. • Hemodynamically significant mitral stenosis or lesions of the left ventricular outflow tract including aortic stenosis or hypertrophic obstructive cardiomyopathy. • Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infective cardiomyopathy (e.g., Chagas’ disease). • Patients with a history of heart transplant or who are on a transplant list (life expectancy 2.0 mg/dL (177 umol/L) at Visit 1, a history of dialysis, or a history of nephrotic syndrome. • Current treatment with cholestyramine and colestipol resins. • History of malignancy including leukemia and lymphoma (but not bas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Evaluate the overall safety and tolerability of aliskiren 150 mg when given in addition to standard therapy in patients with stable heart failure.;Secondary Objective: • Evaluate the efficacy of aliskiren on N-terminal pro-brain natriuretic peptide when added to standard therapy in hypertensive patients with stable heart failure. • Evaluate the efficacy of aliskiren on brain natriuretic peptide (BNP) when added to standard therapy in hypertensive patients with stable heart failure. • Evaluate the efficacy of aliskiren on aldosterone when added to standard therapy in hypertensive patients with stable heart failure. • Evaluate the effect of aliskiren on improvement in signs and symptoms of heart failure and change in NYHA classification from baseline to study end. • Evaluate the effect of aliskiren on cardiac hemodynamics as assessed by echocardiography at baseline and end of study. • Evaluate the blood pressure lowering effect (change from baseline in MSSBP and MSDBP) of aliskiren 150 mg in hypertensive patients with stable heart failure. Refer to protocol for other secondary objectives. ;Primary end point(s): Evaluate the overall safety and tolerability of aliskiren 150 mg when given in addition to standard therapy in hypertensive patients with stable heart failure | — |
Countries
Germany, Italy, Spain, United Kingdom
Outcome results
None listed