AzTrials
AzTrials

Cardiovascular DiseasePhase 2/3NCT01417663

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

A Phase 2/3 study testing Alt-711 and Physical exercise training in people with Cardiovascular Disease and Aging, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Alt-711 and Physical exercise training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteNetherlands
Study dates
Nov 2008to Jun 2011
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Healthy sedentary elderly
  • Age 65 yrs and older

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboud University Nijmegen Medical Centre

    Nijmegen, 6525EZ

Other trials in Netherlands

About this study

Official title: Combining Exercise Training With a Drug to Break AGE-crosslinks; Effects on Cardiovascular Structure and Function and Related Mechanisms

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.

Being tested
Alt-711, Physical exercise training
Keywords
Aging, Cardiovascular disease, Endothelial function, Physical activity, Advanced Glycation Endproducts, AGE crosslink breakers
Medical subject headings
Cardiovascular Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alt-711Drug

    Also called AGE crosslink breaker, Alagebrium, 4,5-dimethyl-3-(2-oxo-2-phenylethyl)-thiazolium chloride

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

  • Physical exercise trainingBehavioural

    Also called Exercise training, Cardiopulmonary fitness training, Cycloergometer

    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%.

Study groups in NCT01417663
Study groupRoleWhat they receive
AlagebriumPlacebo comparatorIn 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
Receives: Drug: Alt-711; Behavioral: Physical exercise training
Exercise trainingOtherIn 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
Receives: Drug: Alt-711; Behavioral: Physical exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 0 and 12 months

Secondary outcomes (5)

  1. 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.

    Measured: 0 and 12 months

  2. 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.

    Measured: 0, 6 and 12 months

  3. 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.

    Measured: 0, 6 and 12 months

  4. 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.

    Measured: 0 and 12 months

  5. 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.

    Measured: 0 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2011 (estimated)
  2. Study startNov 2008
  3. Primary completionJun 2011
  4. Study completionJun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01417663
Sponsor's protocol ID
ALT-711-0529B
Status last verified
Sep 2013
First submitted
17 Jun 2011
Last updated
9 Sep 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24400341

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Alt-711 and Physical exercise training in people with Cardiovascular Disease and Aging, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Examine the combined effects of one year exercise training and the AGE-crosslink breaker Alagebrium on vascular endothelial function. (time frame: 0 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01417663, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in