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Metformin to Reduce Heart Failure After Myocardial Infarction (GIPS-III)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01217307
Recruitment Status : Completed
First Posted : October 8, 2010
Results First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Chris Lexis, University Medical Center Groningen

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: ST Elevation Myocardial Infarction (STEMI)
Coronary Artery Disease
Heart Failure
Diabetes
Interventions: Drug: Metformin
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metformin

metformin 500mg twice daily during 4 months

Metformin: Metformin 500mg twice daily during 4 months

Placebo

Placebo twice daily during 4 months

Placebo: Placebo twice daily during 4 months


Participant Flow:   Overall Study
    Metformin   Placebo
STARTED   191   189 
COMPLETED   191   188 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Metformin

metformin 500mg twice daily during 4 months

Metformin: Metformin 500mg twice daily during 4 months

Placebo

Placebo twice daily during 4 months

Placebo: Placebo twice daily during 4 months

Total Total of all reporting groups

Baseline Measures
   Metformin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 191   189   380 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.7  (11.8)   58.8  (11.5)   58.8  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      47  24.6%      48  25.4%      95  25.0% 
Male      144  75.4%      141  74.6%      285  75.0% 


  Outcome Measures

1.  Primary:   Improvement in Left Ventricular Ejection Fraction   [ Time Frame: 4 months ]

2.  Secondary:   the Incidence of a Cardiovascular Event   [ Time Frame: 4 months and longterm follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Markers of Heart Failure and Glycometabolic State   [ Time Frame: 4 months and longterm follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Myocardial Infarct Size and Transmural Extent of Infarction as Measured With Cardiac Magnetic Resonance Imaging   [ Time Frame: 4 months after hospitalization ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Diastolic Function   [ Time Frame: 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Glycometabolic State   [ Time Frame: 4 months and long-term follow-up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Cardiac MRI After 4 Months, Per Protocol Analysis   [ Time Frame: 4 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. I.C.C. van der Horst
Organization: University Medical Center Groningen
e-mail: i.c.c.van.der.horst@umcg.nl


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Chris Lexis, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01217307     History of Changes
Other Study ID Numbers: GIPS-III 2010B257
First Submitted: October 7, 2010
First Posted: October 8, 2010
Results First Submitted: July 31, 2017
Results First Posted: January 30, 2018
Last Update Posted: January 30, 2018