- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03295734
ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension (ACES)
March 21, 2024 updated by: Thomas W. Buford, University of Alabama at Birmingham
The purpose of this project is to conduct a randomized, controlled trial (RCT) to determine if choice of antihypertensive medication influences changes in functional status and other cardiovascular risk factors among older persons with hypertension when combined with physical exercise.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
The purpose of this project is to conduct a randomized, controlled trial (RCT) to determine if choice of antihypertensive medication influences changes in functional status and other cardiovascular risk factors among older persons with hypertension.
Functional status, determined by measures of physical performance, is an important predictor of cardiovascular outcomes in older adults.
Seniors with compromised function experience more CV events, have a higher risk of undergoing cardiac surgery and higher risk of CVD-related death than higher-functioning peers.
Seniors with hypertension experience accelerated declines in function, and presently physical exercise is the primary strategy for preventing this decline.
However, functional responses to exercise are highly variable and appear to be influenced by the type of antihypertensive medication(s) utilized to control blood pressure.
Preliminary evidence suggests that, compared to other first-line antihypertensive agents, angiotensin converting enzyme (ACE) inhibitors enhance exercise-derived improvements in functional status among hypertensive seniors.
This RCT will test this hypothesis.
Sedentary men and women > 60 years of age with functional limitations and hypertension will be recruited from two sites to participate in a longitudinal intervention study.
Participants will be randomly assigned to one of three first-line antihypertensive agents: (1) the ACE inhibitor perindopril, (2) AT1 receptor antagonist losartan, or (3) the thiazide diuretic hydrochlorothiazide.
Note: Participants with a documented history of hypersensitivity to ACE inhibitors will be randomized 1:1 to one of the two other study drugs.
All participants will also participate in a structured aerobic exercise intervention.
The primary aim is to determine if, compared to losartan and HCTZ, perindopril improves self-paced gait speed.
The secondary aim is to determine the relative effect of perindopril on a) exercise capacity, b) body mass and composition, and c) circulating indices of cardiovascular risk.
This study is expected to differentiate beneficial effects of three FDA-approved antihypertensive medications on an emerging cardiovascular risk factor in a clinically-relevant population.
Thus the study has important implications for expeditiously influencing clinical practice guidelines in the prescription of antihypertensive drugs to millions of Americans.
Study Type
Interventional
Enrollment (Estimated)
213
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thomas Buford, PhD
- Phone Number: 2059963008
- Email: twbuford@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35205
- UAB Center for Exercise Medicine
-
-
Florida
-
Orlando, Florida, United States, 32804
- Translational Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 60 years and older
- Hypertension - untreated (SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg) or treated
- > 290 seconds needed to complete long-distance corridor walk test
- Sedentary lifestyle, defined as <150 min/wk of moderate physical activity
- Willingness to participate in all study procedures, including allowing study team to communicate with primary care physician regarding changes in antihypertensive treatment
Exclusion Criteria:
- BP > 140/90, despite the use of three or more anti-hypertensive drugs
- SBP > 180 mm Hg or DBP > 110 mm Hg
- Chronic kidney disease
- Serum creatinine >2.5 mg/dL in men or >2.0 mg/dL in women
- Serum potassium outside normal reference range
- Urinary protein > 1 on dipstick
- Abnormal liver enzymes (AST, ALT, or alkaline phosphatase > 2.5 times the upper limit of normal)
- Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
- Acute myocardial infarction identified by ECG
- Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental State Examination exam score < 24;
- Simultaneous participation in another intervention trial
- Known hypersensitivity to ACE inhibitors (exclusion only to perindopril arm; will be randomized among other two interventions)
- Any other condition that would preclude participating based upon judgement of PI or study clinician team
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Perindopril
4 mg qd titrated to 8 mg qd perindopril + aerobic exercise
|
Twice weekly centered based aerobic exercise + 3/week home-based walking
4 mg qd titrated to 8 mg qd perindopril
|
Active Comparator: Losartan
50 mg qd titrated to 100 mg qd losartan + aerobic exercise
|
Twice weekly centered based aerobic exercise + 3/week home-based walking
50 mg qd titrated to 100 qd losartan
|
Active Comparator: HCTZ
12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise
|
Twice weekly centered based aerobic exercise + 3/week home-based walking
12.5 mg qd titrated to 25 qd HCTZ
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait speed
Time Frame: 32 weeks
|
Self-paced gait speed over 4m distance
|
32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six minute walk test
Time Frame: 32 weeks
|
maximal distance covered over six minutes
|
32 weeks
|
Body composition
Time Frame: 32 weeks
|
% body fat/lean mass collected via dual x-ray absorptiometry
|
32 weeks
|
Circulating indices of cardiovascular risk
Time Frame: 32 weeks
|
TNF-α, IL-6, VCAM-1, E-selectin; oxidized LDL; myeloperoxidase
|
32 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Thomas Buford, PhD, University of Alabama at Birmingham
- Principal Investigator: Bret Goodpaster, PhD, Translational Research Institute, Advent Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2018
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
September 21, 2017
First Submitted That Met QC Criteria
September 22, 2017
First Posted (Actual)
September 28, 2017
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Hypertension
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Angiotensin-Converting Enzyme Inhibitors
- Losartan
- Perindopril
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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