Effects of Exercise Training and AGE-crosslink Breaker on Cardiovascular Structure and Function

Radboud University Medical Center

Status and phase: Completed; Phase 3; Phase 2

Conditions: Aging; Physical Activity; Endothelial Dysfunction; Cardiovascular Disease

Treatments: Behavioral: Physical exercise training; Drug: Alt-711

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01417663

ALT-711-0529B

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy sedentary elderly
• Age 65 yrs and older

Exclusion criteria

• Cardiovascular disease
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Alagebrium

Placebo Comparator group

Description:

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

Treatment:

Drug: Alt-711

Behavioral: Physical exercise training

Exercise training

Other group

Description:

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

Treatment:

Drug: Alt-711

Behavioral: Physical exercise training