Effects of Exercise Training and AGE-crosslink Breaker on Cardiovascular Structure and Function
NCT ID: NCT01417663
Last Updated: 2013-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
48 participants
INTERVENTIONAL
2008-11-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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Alagebrium
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
Alt-711
Alt-711, also known as Alagebrium, an AGE-crosslink breaker, will be given twice daily 100mg
Physical exercise training
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%.
Exercise training
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
Alt-711
Alt-711, also known as Alagebrium, an AGE-crosslink breaker, will be given twice daily 100mg
Physical exercise training
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%.
Interventions
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Alt-711
Alt-711, also known as Alagebrium, an AGE-crosslink breaker, will be given twice daily 100mg
Physical exercise training
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%.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 65 yrs and older
Exclusion Criteria
* Cerebrovascular disease
* Changes on ECG indicating cardiomyopathy or ischemia
* No cardiovascular medication
* Diabetes Mellitus
* Hypercholesterolemia
* BMI \> 33 kg/m2
* Intensive exercise \> 1 hour a week
65 Years
ALL
Yes
Sponsors
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Dutch Heart Foundation
OTHER
Synvista Therapeutics, Inc
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Maria Hopman
Prof.Dr. M.T.E. Hopman
Principal Investigators
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Maria TE Hopman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Countries
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References
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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.
Other Identifiers
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ALT-711-0529B
Identifier Type: -
Identifier Source: org_study_id