Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Systolic Heart Failure (ESCAPE-SHF)
Tracking Information
Start Date ICMJE | May 2009 |
---|---|
Estimated Primary Completion Date | March 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 ICMJE | Same as current |
Change History | No Changes Posted |
Current Secondary Outcome Measures ICMJE (submitted: June 17, 2009) |
|
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Systolic Heart Failure |
---|---|
Official Title ICMJE | 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 |
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 Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Condition ICMJE | Heart Failure |
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 120 |
---|---|
Completion Date | |
Estimated Primary Completion Date | March 2010 (final data collection date for primary outcome measure) |
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
Gender | Both |
Ages | 18 Years to 75 Years |
Accepts Healthy Volunteers | No |
Contacts ICMJE | |
Location Countries ICMJE | Germany, Poland, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00923156 | ||||
---|---|---|---|---|---|
Responsible Party | External Affairs, Novartis Pharmaceuticals | ||||
Study ID Numbers ICMJE | CSPP100A2252, EudraCT 2008-001035-35 | ||||
Study Sponsor ICMJE | Novartis Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
| ||||
Information Provided By | Novartis | ||||
Verification Date | June 2009 |
Source: http://clinicaltrials.gov/