The Effect of Exercise and Alagebrium on the Diastolic Function of the Heart
AGE
4 other identifiers
interventional
62
1 country
1
Brief Summary
The purpose of this study is to determine whether an investigational drug (Alagebrium (generic: ALT-711), a type of medication referred to as an advanced glycaton end-product clever) can be combined with exercise training to reverse the stiffening of the heart that takes place naturally with aging.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 13, 2009
CompletedFirst Posted
Study publicly available on registry
November 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 7, 2020
August 1, 2020
3.9 years
November 13, 2009
August 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular compliance and distensibility.
One year after enrollment in the study.
Study Arms (4)
Aerobic Exercise Training + Placebo
EXPERIMENTALTai Chi and/or Yoga Training + Placebo
EXPERIMENTALAerobic Exercise Training + Alagebrium
EXPERIMENTALTai Chi and/or Yoga Training + Alagebrium
EXPERIMENTALInterventions
Aerobic exercise training consisting of exercise of choice (walking, eliptical machine, stairstepper, stationary bike, etc.) 4 times per week for 40 minutes at a base pace, and two higher intensity steady state sessions per month.
The dosage of our drug, ALT-711, will be one 100 mg caplet by mouth twice per day for 12 months. Total dose per day 200 mg.
Tai Chi or Yoga training includes a series of exercises that improve flexibility, balance and coordination. Training will be supervised by trained instructors. This training will occur 3 times per week.
Eligibility Criteria
You may qualify if:
- Healthy senior status (age \> 64)
- Body mass index \< 30
- Sedentary status (not exercising \> 2/wk)
You may not qualify if:
- Hypertension
- Diabetes
- Heart Failure
- Asthma
- Chronic obstructive pulmonary disease
- Coronary artery disease (as evidenced by angina or prior myocardial infarction)
- Cerebrovascular disease (as evidenced by prior transient ischemic attack or stroke)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231, United States
Related Publications (1)
Fujimoto N, Hastings JL, Carrick-Ranson G, Shafer KM, Shibata S, Bhella PS, Abdullah SM, Barkley KW, Adams-Huet B, Boyd KN, Livingston SA, Palmer D, Levine BD. Cardiovascular effects of 1 year of alagebrium and endurance exercise training in healthy older individuals. Circ Heart Fail. 2013 Nov;6(6):1155-64. doi: 10.1161/CIRCHEARTFAILURE.113.000440. Epub 2013 Oct 15.
PMID: 24130005DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin D Levine, M.D.
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
November 13, 2009
First Posted
November 17, 2009
Study Start
July 1, 2008
Primary Completion
June 1, 2012
Study Completion
December 1, 2013
Last Updated
August 7, 2020
Record last verified: 2020-08