A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure,, aliskiren,, furosemide,, diuretic efficacy,, interaction
Eligibility Criteria
Inclusion Criteria:
- Systolic or diastolic heart failure, diagnosed with either NYHA functional class II to III at least 3 months prior to screening and on stable medication for at least 12 weeks.
- Patients must have met either of the criteria at screening:
- Documented left ventricular ejection fraction (LVEF) greater than 20% but lower than 40% OR
- Patients with a documented LVEF greater than 40% and with a history of NT-pro-BNP> 400pg/mL (or BNP > 100pg/mL) within 12 months of screening.
Exclusion Criteria:
- Treatment with Angiotensin Receptor Blockers (ARBs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. Beta blockers were permitted provided the dose was stable for at least 3 weeks before the first dose and remains so throughout the study.
- Hypertrophic cardiomyopathy (HCMP).
- If a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily
- Stable heart failure requiring treatment with both an ACE inhibitor and an ARB or Current acute decompensated heart failure.
- Mean sitting systolic blood pressure ≥160 mmHg and/or mean sitting diastolic blood pressure ≥ 100mmHg and/or secondary forms of hypertension.
- Persistent sitting systolic blood pressure <90 mmHg.
- History of angioedema.
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Furosemide 60 mg
Furosemide 60 mg + Aliskiren 150 mg
Furosemide 60 mg + Aliskiren 300 mg
Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.
Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.
Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.