Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Systolic Heart Failure (ESCAPE-SHF)


Tracking Information

Start Date  ICMJEMay 2009
Estimated Primary Completion DateMarch 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2009)		Angiotensin II [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryNo Changes Posted
Current Secondary Outcome Measures ICMJE 
 (submitted: June 17, 2009)
  • Other biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Aliskiren Plasma Concentration (PK) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEEffects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Systolic Heart Failure
Official Title  ICMJEA 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
Brief Summary

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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJEBasic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition  ICMJEHeart Failure
Intervention  ICMJE
  • Drug: aliskiren
  • Drug: ramipril
  • Drug: aliskiren plus ramipril
Study Arms / Comparison Groups
  • aliskiren: Experimental
    Intervention: Drug: aliskiren
  • ramipril: Experimental
    Intervention: Drug: ramipril
  • aliskiren plus ramipril: Experimental
    Intervention: Drug: aliskiren plus ramipril

Recruitment Information

Estimated Enrollment  ICMJE120
Completion Date 
Estimated Primary Completion DateMarch 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

GenderBoth
Ages18 Years to 75 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE 
Location Countries  ICMJEGermany,   Poland,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00923156
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECSPP100A2252, EudraCT 2008-001035-35
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsNovartis Pharmaceuticals
Information Provided ByNovartis
Verification DateJune 2009