HypertensionPhase 2ACESNCT03295734
ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension
A Phase 2 study testing Aerobic exercise, Perindopril and Losartan in people with Hypertension and Aging, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hypertension, Aging, Sedentary Lifestyle
- What is being tested?
- Aerobic exercise, Perindopril and Losartan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 May 2018to 19 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UAB Center for Exercise Medicine
Birmingham, Alabama, 35205
Translational Research Institute
Orlando, Florida, 32804
About this study
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.
Read the 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.
- Conditions
- Hypertension, Aging, Sedentary Lifestyle
- Being tested
- Aerobic exercise, Perindopril, Losartan, HCTZ
- Medical subject headings
- Hypertension, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Twice weekly centered based aerobic exercise + 3/week home-based walking
PerindoprilDrug
4 mg qd titrated to 8 mg qd perindopril
LosartanDrug
50 mg qd titrated to 100 qd losartan
HCTZDrug
12.5 mg qd titrated to 25 qd HCTZ
| Study group | Role | What they receive |
|---|---|---|
| Perindopril | Active comparator | 4 mg qd titrated to 8 mg qd perindopril + aerobic exercise Receives: Behavioral: Aerobic exercise; Drug: Perindopril |
| Losartan | Active comparator | 50 mg qd titrated to 100 mg qd losartan + aerobic exercise Receives: Behavioral: Aerobic exercise; Drug: Losartan |
| HCTZ | Active comparator | 12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise Receives: Behavioral: Aerobic exercise; Drug: HCTZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Speed From Baseline
Self-paced gait speed over 4m distance; change from baseline to week 32
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start29 May 2018
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, AdventHealth Translational Research Institute
- Responsible party
- Principal investigator, Thomas W. Buford, University of Alabama at Birmingham
- Investigators
- Thomas Buford, PhD, Principal investigator, University of Alabama at BirminghamBret Goodpaster, PhD, Principal investigator, Translational Research Institute, Advent Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295734
- Acronym
- ACES
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2017
- Last updated
- 22 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harper SA, Baptista LC, Roberts LM, Wherry SJ, Boxer RS, Hildreth KL, Seay RS, Allman PH, Carter CS, Aban I, Kohrt WM, Buford TW. Angiotensin Converting Enzyme Inhibitors Combined with Exercise for Hypertensive Seniors (The ACES Trial): Study Protocol of a Randomized Controlled Trial. Front Med (Lausanne). 2020 Jan 22;6:327. doi: 10.3389/fmed.2019.00327. eCollection 2019.
PubMed 32039215
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension
- ClinicalTrials.gov ID
- NCT03295734
- Acronym / sponsor ID
- ACES
- Conditions
- Hypertension, Aging, Sedentary Lifestyle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, AdventHealth Translational Research Institute
- Study start
- 29 May 2018 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 28 Sep 2017 (actual)
- Results
- Posted 22 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perindopril | Active comparator | Behavioral: Aerobic exercise, Drug: Perindopril4 mg qd titrated to 8 mg qd perindopril + aerobic exercise |
| Losartan | Active comparator | Behavioral: Aerobic exercise, Drug: Losartan50 mg qd titrated to 100 mg qd losartan + aerobic exercise |
| HCTZ | Active comparator | Behavioral: Aerobic exercise, Drug: HCTZ12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseTwice weekly centered based aerobic exercise + 3/week home-based walking | Behavioural | HCTZ, Losartan, Perindopril |
| Perindopril4 mg qd titrated to 8 mg qd perindopril | Drug | Perindopril |
| Losartan50 mg qd titrated to 100 qd losartan | Drug | Losartan |
| HCTZ12.5 mg qd titrated to 25 qd HCTZ | Drug | HCTZ |
Primary outcome
Change in Gait Speed From Baseline
Time frame: 32 weeks
Self-paced gait speed over 4m distance; change from baseline to week 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32039215Harper SA, Baptista LC, Roberts LM, Wherry SJ, Boxer RS, Hildreth KL, Seay RS, Allman PH, Carter CS, Aban I, Kohrt WM, Buford TW. Angiotensin Converting Enzyme Inhibitors Combined with Exercise for Hypertensive Seniors (The ACES Trial): Study Protocol of a Randomized Controlled Trial. Front Med (Lausanne). 2020 Jan 22;6:327. doi: 10.3389/fmed.2019.00327. eCollection 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Buford, PhD principal investigator
University of Alabama at Birmingham
Bret Goodpaster, PhD principal investigator
Translational Research Institute, Advent Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic exercise, Perindopril and Losartan in people with Hypertension and Aging, run by University of Alabama at Birmingham at 2 sites in United States.
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 5 inclusion and 13 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Gait Speed From Baseline (time frame: 32 weeks). 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 NCT03295734, 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 22 Jul 2025.