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

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00923156

Purpose

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. An increase of angiotensin II is associated with worsening of heart failure. Therefore the study will test the effects of ramipril, aliskiren and the combination of both on levels on angiotensin II in the blood in patients with systolic heart failure.

Condition	Intervention	Phase
Heart Failure	Drug: aliskiren Drug: ramipril Drug: aliskiren plus ramipril	Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	A Double-Blind, Randomized, Multicenter, Parallel Group Study to Evaluate the Effects of Aliskiren, Ramipril and Combination Treatment on Plasma Concentration of Angiotensin II in Patients With Decompensated Chronic Systolic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Angiotensin II Ramipril Aliskiren Angiotensin II, ile(5)-

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Angiotensin II [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Aliskiren Plasma Concentration (PK) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	May 2009
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
aliskiren: Experimental	Drug: aliskiren
ramipril: Experimental	Drug: ramipril
aliskiren plus ramipril: Experimental	Drug: aliskiren plus ramipril

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Decompensated chronic systolic heart failure
Brain natriuretic peptide (BNP) level ≥ 100 pg/mL

Exclusion criteria:

History of requirement of both ACE and ARB inhibitor treatment
Acute heart failure secondary to acute myocardial infarction, acute coronary syndrome or new tachyarrhythmia
Occurrence of unstable angina or myocardial infarction within 12 weeks prior to screening
History of cardiomyopathy such as postpartum, restrictive, infective, hypertrophic obstructive
History of right heart failure due to pulmonary disease
History of untreated second or third degree atrioventricular heart block

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923156

Locations

Germany
Novartis Investigator Site	Not yet recruiting
Berlin, Germany, 12207
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Göttingen, Germany, 37057
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Berlin, Germany, 13353
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Bad Krozingen, Germany, 79189
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Jena, Germany, 07747
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
München, Germany, 80336
Contact: Novartis Germany +41 61 324 1111
Poland
Novartis Investigator Site	Not yet recruiting
Wroclaw, Poland, 50-981
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Poznan, Poland, 61-848
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Warszawa, Poland, 02-507
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Lublin, Poland, 20-090
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Krakow, Poland, 31-501
Contact: Novartis Germany +41 61 324 1111
Russian Federation
Novartis Investigator Site	Not yet recruiting
Moscow, Russian Federation, 121552
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Moscow, Russian Federation, 119620
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Recruiting
Moscow, Russian Federation, 121309
Contact: Novartis Germany +41 61 324 1111
Novartis Investigator Site	Not yet recruiting
Moscow, Russian Federation, 117292
Contact: Nov +41 61 324 1111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CSPP100A2252, EudraCT 2008-001035-35
Study First Received:	June 17, 2009
Last Updated:	June 17, 2009
ClinicalTrials.gov Identifier:	NCT00923156 History of Changes
Health Authority:	United States: Food and Drug Administration; Russia: Ministry of Health and Social Development of the Russian Federation; Poland: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Heart failure,
Systolic,
Aliskiren,
Ramipril,
Angiotensin II,
Ang II,
Plasma Renin Activity,
PRA,

Plasma Renin Concentration,
PRC,
brain natriuretic peptide,
BNP,
urinary aldosterone,
Escape,
Pharmacokinetic,
PK.

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Angiotensin II
Ramipril

Pharmacologic Actions
Heart Failure, Systolic
Protease Inhibitors
Therapeutic Uses
Vasoconstrictor Agents
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010