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Protocol Summary for 112670

Protocol Summary
Protocol Id: 112670
Secondary Ids:
Title: A multi-center, placebo-controlled study to evaluate the safety of GSK716155 and its effects on myocardial metabolism, myocardial function, and exercise capacity in patients with NYHA Class II/III congestive heart failure
Phase: phase 2
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CBER
IND/IDE Number: 65,177
IND/IDE Serial Number: TBD
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • Europe: European Medicines Agency
  • United States: Food and Drug Administration
Collaborators:
Brief Summary: This exploratory proof of concept study will be conducted in patients with stable New York Heart Association (NYHA) Class II-III heart failure. The focus of the efficacy endpoints is to test the hypothesis that GSK716155 administration will increase glucose uptake and utilization in the myocardium, resulting in increased myocardial efficiency and increased exercise capacity. A positive result, defined as either statistically significant effects on one or more of the efficacy endpoints or as an overall signal suggesting a clinically relevant effect on myocardial physiology, would provide evidence for potential progression into further development in a chronic heart failure population.
Detailed Description:
Record Verification Date: April 2013
Status: Completed
Why Study Stopped:
Study Start Date: September 2010
Study Completion Date: August 2012
Study Completion Date Type: Actual
Primary Completion Date: August 2012
Primary Completion Date Type: Actual
Primary Purpose: basic
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: yes
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Myocardial efficiency (work performed/MVO2) assessed at rest: a.) Work calculated by cardiac echo and b.)b. MVO2 accessed via 11C-acetate PET imaging Up to 3 months
  • Peak oxygen uptake (VO2 max) as assessed by bicycle cardiopulmonary exercise testing Up to 3 months
  • Myocardial glucose utilization as assessed by FDG-PET imaging Up to 3 months
Secondary Outcomes:
  • Safety endpoints including but not limited to: a.) incidence and severity of AEs b.) all cause mortality c.) hospitalization for heart failure Up to 3 months
  • Exploratory PK parameters may be measured including (but not limited to) AUC, CMAX and Ct. Up to 3 months
  • Cardiac energetics (PCr/ATP) measured by 31P MRS Up to 3 months
  • Exercise capacity assessed by 6-minute walk test Up to 3 months
  • Cardiac and liver fat by proton spectroscopy (1H MRS) Up to 3 months
  • LV and RV function assessed by CMR (LVEF, LV and RV volumes in systole and diastole, LV mass), myocardial strain assessed by myocardial tagging indices Up to 3 months
  • Plasma levels of glucose, insulin, free fatty acids; HOMA index Up to 3 months
  • Serum NT-BNP level Up to 3 months
  • Left ventricular function (LVEF, LV volumes in systole and diastole) as assessed by echocardiogram Up to 3 months
  • Quality of life as assessed by the Minnesota Living with Heart Failure Questionnaire Up to 3 months
Conditions:
  • Heart failure, Congestive
Keywords:
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 21 Year
Maximum Age: 75 Year
Enrollment: 70
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information