Clinical trial NCT01417663: Effects of Exercise Training and AGE-crosslink Breaker on Cardiovascular Structure and Function
Official title: Combining Exercise Training With a Drug to Break AGE-crosslinks; Effects on Cardiovascular Structure and Function and Related Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cardiovascular Disease
Aging
Endothelial Dysfunction
Physical Activity
Keywords: Aging
Cardiovascular disease
Endothelial function
Physical activity
Advanced Glycation Endproducts
AGE crosslink breakers
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
name: Synvista Therapeutics, Inc
First posted: 2011-08-16
Enrollment: 48
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function.
timeFrame: 0 and 12 months
Secondary outcomes:
measure: Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function.
timeFrame: 0 and 12 months
measure: Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cardiac function.
timeFrame: 0, 6 and 12 months
measure: Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cardiac function.
timeFrame: 0, 6 and 12 months
measure: Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cerebral perfusion and cognitive function.
timeFrame: 0 and 12 months
measure: Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cerebral perfusion and cognitive function.
timeFrame: 0 and 12 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Maria TE Hopman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.