Trial · NCT01357850
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
NCT01357850, Phase 2, Completed, GlaxoSmithKline; results first posted 2014-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT01357850. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01357850
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT01357850
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 82 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Heart Failure, Congestive
- Interventions
- GSK716155, Placebo
- First posted
- 2011-05-23
- Last updated
- 2017-08-17
- Results first posted
- 2014-10-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging | Baseline and Week 13 | FDG-PET imaging was performed at Baseline and Week 13 to assess myocardial glucose uptake. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects analysis of variance (ANOVA) model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects. |
| Primary | Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest | Baseline and Week 13 | MVO2 was estimated by measuring the rate of myocardial clearance of 11C-activity which represents overall myocardial oxidative flux through the TCA cycle. Cardiac work was measured by echocardiography and cardiac efficiency index was calculated as work (by echocardiography) divided by MVO2. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects. |
| Primary | Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing | Baseline and Week 13 | Peak VO2 was measured at Baseline and Week 13. Participants performed a maximal exercise test limited by dyspnea or fatigue on a cycle ergometer. After a rest period, the workloads were increased in a step fashion by 25 watts every 3 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on analysis using a mixed effects ANOVA model, fitting terms for treatment, visit and interaction of treatment and visit, with participants as random effects. |
| Secondary | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram | Baseline and Week 13 | Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave, and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in Left Ventricular (LV) Volumes in Systole and Diastole as Assessed by Echocardiogram | Baseline and Week 13 | Echocardiography was performed at Baseline and Week 13 using pulse-wave, continuous-wave and tissue Doppler. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in LV and RV Function Assessed by Cardiac Magnetic Resonance (CMR) (LVEF), Myocardial Strain Assessed by Myocardial Tagging Indices | Baseline and Week 13 | Non-contrast CMR to assess left ventricular (LV) and right ventricular (RV) ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Only those participants available at the specified time points were analyzed. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in LV and RV Function Assessed by CMR (LV and RV Volumes in Systole and Diastole), Myocardial Strain Assessed by Myocardial Tagging Indices | Baseline and Week 13 | Non-contrast CMR to assess LV and RV ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in LV and RV Function Assessed by CMR (LV Mass), Myocardial Strain Assessed by Myocardial Tagging Indices | Baseline and Week 13 | Non-contrast CMR to assess left/right ventricular ejection fraction, volume, mass, and strain was performed following a period of rest after exercise testing at Baseline and after the Week 13 treatment phase. A 3Tesla magnetic resonance imagine (MRI) examination was performed including sequences for evaluation of LV structure and function. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in Cardiac Energetics (PCr/ATP) Measured by 31P Magnetic Resonance Spectroscopy (MRS) | Baseline and Week 13 | Participants underwent a CMR scan performed on a 3 Tesla MR system at Baseline and Week 13 to assess cardiac mass, volumes (global function and dilatation), strain and torsion, cardiac and liver lipid content and cardiac energy metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Secondary | Change From Baseline in Cardiac and Liver Fat by Proton Spectroscopy (1H MRS) | Baseline and Week 13 | Change in Baseline in cardiac and liver fat by proton spectroscopy was planned at Baseline and Week 13. The protocol allowed for sites to perform all or only efficacy assessments, depending on site designation, capability and feasibility. No sites that enrolled participants into this study were able to perform this outcome measure. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging | Baseline and Week 13 | Intent-to-Treat (ITT) Population: all randomized participants who received \>= 1 dose of study medication and had \>= 1 on treatment assessment. Only those participants available at the specified time points were analyzed. | micromoles per gram per minute | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest | Baseline and Week 13 | ITT Population. Only those participants available at the specified time points were analyzed. | millimeters of mercury/liter/minute2 | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing | Baseline and Week 13 | ITT Population. Only those participants available at the specified time points were analyzed. | Milliliters per kilogram per minute | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) as Assessed by Echocardiogram | Baseline and Week 13 | ITT Population. Only those participants available at the specified time points were analyzed. | Percentage | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Left Ventricular (LV) Volumes in Systole and Diastole as Assessed by Echocardiogram | Baseline and Week 13 | ITT Population. Only those participants available at the specified time points were analyzed. | Milliliters | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in LV and RV Function Assessed by Cardiac Magnetic Resonance (CMR) (LVEF), Myocardial Strain Assessed by Myocardial Tagging Indices | Baseline and Week 13 | CMR Substudy Population: all randomized participants who participated in the CMR substudy and had valid Baseline and/or Week 13 assessments for \>= 1 one of the imaging parameters of 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. | Percentage | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in LV and RV Function Assessed by CMR (LV and RV Volumes in Systole and Diastole), Myocardial Strain Assessed by Myocardial Tagging Indices | Baseline and Week 13 | CMR Substudy Population. Only those participants available at the specified time points were analyzed. | Milliliters | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in LV and RV Function Assessed by CMR (LV Mass), Myocardial Strain Assessed by Myocardial Tagging Indices | Baseline and Week 13 | CMR Substudy Population. Only those participants available at the specified time points were analyzed. | Grams | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Cardiac Energetics (PCr/ATP) Measured by 31P Magnetic Resonance Spectroscopy (MRS) | Baseline and Week 13 | Magnetic Resonance Substudy Population (MRS): all randomized participants who participated in the MRS substudy and had valid Baseline and/or Week 13 assessments for either PCr/ATP via 31P MRS. Only those participants available at the specified time points were analyzed. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Cardiac and Liver Fat by Proton Spectroscopy (1H MRS) | Baseline and Week 13 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group86
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging | Placebo | 0.0185 | 95% Confidence Interval -0.0158 to 0.0528 | micromoles per gram per minute | |
| Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging | Albiglutide 3.75 mg | 0.0103 | 95% Confidence Interval -0.0440 to 0.0646 | micromoles per gram per minute | |
| Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging | Albiglutide 15 mg | 0.0369 | 95% Confidence Interval 0.0042 to 0.0695 | micromoles per gram per minute | |
| Change From Baseline in Myocardial Glucose Utilization as Assessed by [18F]Fluoro-2-deoxy-glucose Positron Emission Tomography (FDG-PET) Imaging | Albiglutide 30 mg | 0.0059 | 95% Confidence Interval -0.0268 to 0.0386 | micromoles per gram per minute | |
| Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest | Placebo | -1051.90 | 95% Confidence Interval -3136.43 to 1032.63 | millimeters of mercury/liter/minute2 | |
| Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest | Albiglutide 3.75 mg | -1070.09 | 95% Confidence Interval -3846.14 to 1705.95 | millimeters of mercury/liter/minute2 | |
| Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest | Albiglutide 15 mg | -348.58 | 95% Confidence Interval -2278.39 to 1581.23 | millimeters of mercury/liter/minute2 | |
| Change From Baseline in Myocardial Efficiency (Work Performed/Myocardial Oxygen Consumption [MVO2]) Assessed at Rest | Albiglutide 30 mg | -870.64 | 95% Confidence Interval -2771.39 to 1030.11 | millimeters of mercury/liter/minute2 | |
| Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing | Placebo | -0.63 | 95% Confidence Interval -1.53 to 0.27 | Milliliters per kilogram per minute | |
| Change From Baseline in Peak Oxygen Uptake (Peak VO2) as Assessed by Bicycle Cardiopulmonary Exercise Testing | Albiglutide 3.75 mg | 0.05 | 95% Confidence Interval -1.35 to 1.45 | Milliliters per kilogram per minute |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 30 | |
| Overall Study | STARTED | Albiglutide 3.75 mg | 12 | |
| Overall Study | STARTED | Albiglutide 15 mg | 13 | |
| Overall Study | STARTED | Albiglutide 30 mg | 27 | |
| Overall Study | COMPLETED | Placebo | 29 | |
| Overall Study | COMPLETED | Albiglutide 3.75 mg | 12 | |
| Overall Study | COMPLETED | Albiglutide 15 mg | 13 | |
| Overall Study | COMPLETED | Albiglutide 30 mg | 27 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Albiglutide 3.75 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events340
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 5 | 30 | |
| other | Diarrhoea | Gastrointestinal disorders | Albiglutide 3.75 mg | 2 | 12 | |
| other | Diarrhoea | Gastrointestinal disorders | Albiglutide 15 mg | 3 | 13 | |
| other | Diarrhoea | Gastrointestinal disorders | Albiglutide 30 mg | 4 | 27 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 30 | |
| other | Vomiting | Gastrointestinal disorders | Albiglutide 3.75 mg | 0 | 12 | |
| other | Vomiting | Gastrointestinal disorders | Albiglutide 15 mg | 1 | 13 | |
| other | Vomiting | Gastrointestinal disorders | Albiglutide 30 mg | 2 | 27 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 1 | 30 | |
| other | Constipation | Gastrointestinal disorders | Albiglutide 3.75 mg | 0 | 12 |
1 to 10 of 340Source ClinicalTrials.gov
See all 340 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Albiglutide 3.75 mg | ||
| Total, all-cause mortality | Albiglutide 15 mg | ||
| Total, all-cause mortality | Albiglutide 30 mg | ||
| Total, other adverse events | Placebo | 22 | 30 |
| Total, other adverse events | Albiglutide 3.75 mg | 11 | 12 |
| Total, other adverse events | Albiglutide 15 mg | 11 | 13 |
| Total, other adverse events | Albiglutide 30 mg | 19 | 27 |
| Total, serious adverse events | Placebo | 4 | 30 |
| Total, serious adverse events | Albiglutide 3.75 mg | 2 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27039125 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01357850
GET https://conductscience.org/api/trials/v1/NCT01357850/results?page=2