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| Name | Class |
|---|---|
| Dutch Heart Foundation | OTHER |
| Synvista Therapeutics, Inc | INDUSTRY |
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Healthy but sedentary aging leads to increased morbidity and mortality of cardiovascular disease. This is partly due to the accumulation of Advanced Glycation Endproducts (AGEs) and the stiffening of the myocardium and arteries. New medication has been developed to break these AGE-crosslinks to improve cardiovascular compliance. The positive influence of regular physical activity is well known for cardiovascular disease and aging. Therefore, what is the most effective intervention, physical exercise and/or new medication AGE-crosslink breakers, in improving the cardiovascular and cerebrovascular compliance and improving the endothelial function in healthy sedentary elderly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alagebrium | Placebo Comparator | In this study there will be four different groups: One Alagebrium 100 mg twice daily and exercise training 3x/week Two Placebo twice daily and exercise training 3x/week Three Alagebrium 100 mg twice daily and no exercise training Four Placebo twice daily and no exercise training |
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| Exercise training | Other | In this study there will be four different groups: One Alagebrium 100 mg twice daily and exercise training 3x/week Two Placebo twice daily and exercise training 3x/week Three Alagebrium 100 mg twice daily and no exercise training Four Placebo twice daily and no exercise training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alt-711 | Drug | Alt-711, also known as Alagebrium, an AGE-crosslink breaker, will be given twice daily 100mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function. | At baseline and 12 months the endothelial function will be measured with an invasive vascular function measurement using the leg model. Via an arterial line in the common femoral artery acethylcholine, sodium nitroprusside and LNMMA will be infused at different dosages. Vascular response will be measured using venous occlusion plethysmography. Non-invasive vascular measurements, e.g.flow mediated dilation and pulse wave velocity, using ultrasound techniques will be performed at 0, 6 and 12 months. Also, cardiopulmonary fitness level will be tested at 0, 3, 6 and 12 months with an ergometer. | 0 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function. | At baseline and 12 months the endothelial function will be measured with an invasive vascular function measurement using the leg model. Via an arterial line in the common femoral artery acethylcholine, sodium nitroprusside and LNMMA will be infused at different dosages. Vascular response will be measured using venous occlusion plethysmography. Non-invasive vascular measurements, e.g.flow mediated dilation and pulse wave velocity, using ultrasound techniques will be performed at 0, 6 and 12 months. Also, cardiopulmonary fitness level will be tested at 0, 3, 6 and 12 months with an ergometer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria TE Hopman, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Nijmegen Medical Centre | Nijmegen | 6525EZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24400341 | Derived | Oudegeest-Sander MH, Olde Rikkert MG, Smits P, Thijssen DH, van Dijk AP, Levine BD, Hopman MT. The effect of an advanced glycation end-product crosslink breaker and exercise training on vascular function in older individuals: a randomized factorial design trial. Exp Gerontol. 2013 Dec;48(12):1509-17. doi: 10.1016/j.exger.2013.10.009. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 13, 2016 | |
| Reset | Feb 11, 2016 | |
| Release | Oct 9, 2017 | |
| Reset | Nov 7, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 13, 2016 | Feb 11, 2016 | |||
| Oct 9, 2017 |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C406794 | alagebrium |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Physical exercise training | Behavioral | Exercise training will be given three times a week for 45 minutes per training session. The heart rate reserve will be slowly increased from 70% to 85%. |
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| 0 and 12 months |
| Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cardiac function. | An echocardiogram will be performed at baseline, 6 and 12 months. Measures such as strain, strain rate and myocardial velocity, together with the diastolic function parameters (e.g. E/A, S/D, and E/E' ratio) will be specifically evaluated. Also, the common measures such as wall thickness, volumes, etc, will be examined. | 0, 6 and 12 months |
| Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cardiac function. | An echocardiogram will be performed at baseline, 6 and 12 months. Measures such as strain, strain rate and myocardial velocity, together with the diastolic function parameters (e.g. E/A, S/D, and E/E' ratio) will be specifically evaluated. Also, the common measures such as wall thickness, volumes, etc, will be examined. | 0, 6 and 12 months |
| Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cerebral perfusion and cognitive function. | A cerebral perfusion measurement will be performed at baseline and after 12 months with transcranial doppler, near infra-red spectroscopy and continuous beat to beat blood pressure monitoring using the Finameter during different posture maneuvers and hypo- and hypercapnia. Dynamic cerebral autoregulation and vasoreactivity will be examined. Cognitive function will be measured at baseline, 6 and 12 months using the CANTAB. | 0 and 12 months |
| Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cerebral perfusion and cognitive function. | A cerebral perfusion measurement will be performed at baseline and after 12 months with transcranial doppler, near infra-red spectroscopy and continuous beat to beat blood pressure monitoring using the Finameter during different posture maneuvers and hypo- and hypercapnia. Dynamic cerebral autoregulation and vasoreactivity will be examined. Cognitive function will be measured at baseline, 6 and 12 months using the CANTAB. | 0 and 12 months |
| Nov 7, 2017 |