A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure

Novartis

Status and phase

Completed

Phase 2

Conditions

Heart Failure

Treatments

Drug: Aliskiren 150 mg

Drug: Aliskiren 300 mg

Drug: Furosemide 60 mg

Drug: Placebo for Aliskiren

Study type

Interventional

Funder types

Industry

Identifiers

NCT01125514

CSPP100A2255

Details and patient eligibility

About

This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.

Enrollment

37 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

37 participants in 3 patient groups

Furosemide 60 mg

Experimental group

Description:

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:

Drug: Placebo for Aliskiren

Drug: Furosemide 60 mg

Furosemide 60 mg + Aliskiren 150 mg

Experimental group

Description:

Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.

Treatment:

Drug: Placebo for Aliskiren

Drug: Furosemide 60 mg

Drug: Aliskiren 150 mg

Furosemide 60 mg + Aliskiren 300 mg