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

07:28 EDT 23rd May 2013 | BioPortfolio

Summary

This study will assess the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (80 mg) in patients with heart failure.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Heart Failure

Intervention

Furosemide, 80 mg; Aliskiren, 150 and 300 mg; Placebo for Aliskiren

Location

Novartis Investigative Site
Berlin
Germany

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

Heart Failure

A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.

Cardiomegaly

Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.

Heart Failure, Diastolic

Heart failure caused by abnormal myocardial relaxation during DIASTOLE leading to defective cardiac filling.

Heart Failure, Systolic

Heart failure caused by abnormal myocardial contraction during SYSTOLE leading to defective cardiac emptying.

Cardiotonic Agents

Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE).

Clinical Trials [ 1222 Associated Clinical Trials listed on BioPortfolio]

“ALOFT – Aliskiren Observation of Heart Failure Treatment”: Efficacy and Safety of Aliskiren Added on Top of Standard Therapy in Adults (≥ 18 Years) With Stable Heart Failure

This study was designed to determine if patients, who have both high blood pressure and heart failure and are currently receiving drug treatment for heart failure, have an improvement in t...

Hemodynamic Effects of Aliskiren Compared to Captopril on the Kidney in Healthy Volunteers on a Low- and High- Sodium Diet

This study will measure the effects of different doses of aliskiren on kidney blood flow and function in healthy adults and determine how salt intake affects the response to aliskiren.

Effects of Aliskiren on Patient With Heart Failure and a Normal Ejection Fraction

The primary objective of this study is to determine whether treatment with aliskiren (300 mg) compared to placebo will improve treadmill exercise time in older (age ≥ 55 years) patients...

Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Systolic Heart Failure

In addition to the blood pressure lowering effects of aliskiren, it may have beneficial effects on blocking the so called RAAS (renin-angiotensin-aldosterone system) at the tissue level. A...

Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbi-mortality in Patients With Chronic Heart Failure

The study will evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy as compared to enalapril monotherapy, on morbidity and mortality i...

PubMed Articles [ 11823 Associated PubMed Articles listed on BioPortfolio]

Aliskiren-associated acute kidney injury in a patient with pre-existing chronic kidney disease and dilated cardiomyopathy.

We report a case of acute kidney injury (AKI) caused by a novel direct renin inhibitor, aliskiren. A 43-year-old Japanese man with dilated cardiomyopathy on cardiac resynchronization therapy with defi...

Antihypertensive Efficacy and Tolerability of Aliskiren/Amlodipine Single-Pill Combinations in Patients with an Inadequate Response to Aliskiren Monotherapy.

Many patients with hypertension will require multiple antihypertensive drugs to achieve blood pressure (BP) control. This double-blind study evaluated the efficacy and safety of aliskiren/amlodipine s...

Aliskiren in Patients with Diabetes: A Systematic Review.

Objective: Diabetic patients are at risk of macro- and micro-vascular complications, including diabetic nephropathy, and have difficulties in achieving blood pressure (BP) goals. Aliskiren, a direct r...

Intestinal OATP1A2 inhibition as a potential mechanism for the effect of grapefruit juice on aliskiren pharmacokinetics in healthy subjects.

PURPOSE: To conduct a mechanistic investigation of the interaction between aliskiren and grapefruit juice in healthy subjects. METHODS:...

Aliskiren reduces home blood pressure and albuminuria in patients with hypertensive nephrosclerosis.

BACKGROUND: The aim of this study was to investigate the antialbuminuric and antihypertensive effects of aliskiren by monitoring home blood pressure (BP) in comparison with the effects of the angioten...

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