NCT01417663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2011

Completed
Last Updated

September 9, 2013

Status Verified

September 1, 2013

Enrollment Period

2.6 years

First QC Date

June 17, 2011

Last Update Submit

September 6, 2013

Conditions

Cardiovascular DiseaseAgingEndothelial DysfunctionPhysical Activity

Keywords

AgingCardiovascular diseaseEndothelial functionPhysical activityAdvanced Glycation EndproductsAGE crosslink breakers

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function.

    0 and 12 months

  • Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cardiac function.

    0, 6 and 12 months

  • Examine the individual effects of one year exercise training and the AGE-crosslink breaker Alagebrium on cardiac function.

    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.

    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.

    0 and 12 months

Study Arms (2)

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

Drug: Alt-711Behavioral: Physical exercise training

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

Drug: Alt-711Behavioral: Physical exercise training

Interventions

Alt-711DRUG

Alt-711, also known as Alagebrium, an AGE-crosslink breaker, will be given twice daily 100mg

Also known as: AGE crosslink breaker, Alagebrium, 4,5-dimethyl-3-(2-oxo-2-phenylethyl)-thiazolium chloride
AlagebriumExercise training
Physical exercise trainingBEHAVIORAL

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%.

Also known as: Exercise training, Cardiopulmonary fitness training, Cycloergometer
AlagebriumExercise training

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy sedentary elderly
  • Age 65 yrs and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6525EZ, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24400341DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesMotor Activity

Interventions

alagebriumExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria TE Hopman, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr. M.T.E. Hopman

Study Record Dates

First Submitted

June 17, 2011

First Posted

August 16, 2011

Study Start

November 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

September 9, 2013

Record last verified: 2013-09

Locations

NL(1)