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Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Systolic Heart Failure (ESCAPE-SHF)
This study is currently recruiting participants.
Verified September 2010 by Novartis

First Received on June 17, 2009.   Last Updated on September 30, 2010   History of Changes
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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aliskiren Drug: aliskiren
Experimental: ramipril Drug: ramipril
Experimental: aliskiren plus ramipril Drug: aliskiren plus ramipril

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Novartis Pharmaceuticals +41 31 324 1111

Locations
Germany
Novartis Investigator Site Not yet recruiting
Bad Krozingen, Germany, 79189
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigator Site Not yet recruiting
Berlin, Germany, 12207
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigator Site Recruiting
Berlin, Germany, 13353
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigator Site Recruiting
Göttingen, Germany, 37057
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 Recruiting
Krakow, Poland, 31-501
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigator Site Recruiting
Lublin, Poland, 20-090
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigator Site Recruiting
Poznan, Poland, 61-848
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigator Site Recruiting
Warszawa, Poland, 02-507
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigator Site Recruiting
Wroclaw, Poland, 50-981
Contact: Novartis Germany     +41 61 324 1111        
Russian Federation
Novartis Investigator Site Recruiting
Moscow, Russian Federation, 117292
Contact: Nov     +41 61 324 1111        
Novartis Investigator Site Recruiting
Moscow, Russian Federation, 121309
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigative Site Recruiting
Moscow, Russian Federation
Novartis Investigator Site Recruiting
Moscow, Russian Federation, 121552
Contact: Novartis Germany     +41 61 324 1111        
Novartis Investigator Site Recruiting
Moscow, Russian Federation, 119620
Contact: Novartis Germany     +41 61 324 1111        
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00923156     History of Changes
Other Study ID Numbers: CSPP100A2252, EudraCT 2008-001035-35
Study First Received: June 17, 2009
Last Updated: September 30, 2010
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 Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Angiotensin II
Natriuretic Peptide, Brain
Ramipril
Vasoconstrictor Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Natriuretic Agents
Physiological Effects of Drugs
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents

ClinicalTrials.gov processed this record on February 09, 2012



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