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Tracking Information | |||||||||
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First Received Date † | May 15, 2007 | ||||||||
Last Updated Date | February 25, 2009 | ||||||||
Start Date † | August 2007 | ||||||||
Current Primary Outcome Measures † |
Exercise capacity before and after 4 months of intervention [ Time Frame: 4 months ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00473876 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
Possible mechanisms that can explain the improvement of exercise capacity [ Time Frame: 4 months ] [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Metformin in Insulin Resistant Left Ventricular (LV) Dysfunction (TAYSIDE Trial) | ||||||||
Official Title † | Metformin in Insulin Resistant LV Dysfunction, a Double-Blind, Placebo-Controlled Trial (TAYSIDE Trial) | ||||||||
Brief Summary | Will metformin improve exercise capacity in chronic heart failure patients who has insulin resistance (pre-diabetic- means before they become diabetic)? |
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Detailed Description | Exercise incapacity is one of the major debilitating symptoms of heart failure patients. Studies showed that heart failure patients will become insulin resistance (IR) or vice versa, severity of heart failure also correlates with the severity of insulin resistance. A recent study demonstrated that if we correct diabetic patient insulin resistance by giving them a drug to make them more sensitive to the effects of insulin, their exercise capacity improves. Therefore, we think that the same effects might happen in heart failure patients who have been identified to the insulin resistance by blood test. Insulin resistance means that they have not yet become diabetic and it is a stage the diabetic patients go through before they develop diabetes. Therefore, we plan to use a drug called metformin (a diabetic drug), give it to heart failure patients who also have IR for 4 months and examine the effects before and after 4 months of treatment. It is a double blind control study, therefore, neither the examiner nor the patient know which drug they receive (either active drug- Metformin, or a placebo). The main objective is to assess their exercise capacity using an exercise test called Innocor System. It is a bicycle based exercise test that involves patient breathing into a mouth piece before and during exercise in order for the machine to work out the maximum oxygen consumption and pumping power of the heart. The other objectives of the trial are looking at the possible mechanisms of improving exercise capacity. We aim to answer the following questions by doing the following tests: Does exercise capacity improve because of
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Study Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 66 | ||||||||
Estimated Completion Date | April 2009 | ||||||||
Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
Therefore, patients with angina or other cardiac or pulmonary symptoms potentially limiting exercise performance will be excluded.
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Gender | Both | ||||||||
Ages | 25 Years to 80 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United Kingdom | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00473876 | ||||||||
Responsible Party | Dr Aaron KF Wong, University of Dundee | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | University of Dundee | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | University of Dundee | ||||||||
Verification Date | February 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |