A Phase 2 interventional study of Aerobic exercise and Perindopril in Hypertension, Aging and Sedentary Lifestyle, sponsored by University of Alabama at Birmingham. Completed at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by University of Alabama at Birmingham · Phase 2, Interventional, and Prevention
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.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 223 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
4 mg qd titrated to 8 mg qd perindopril + aerobic exercise
Behavioral: Aerobic exercise · Drug: Perindopril
50 mg qd titrated to 100 mg qd losartan + aerobic exercise
Behavioral: Aerobic exercise · Drug: Losartan
12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise
Behavioral: Aerobic exercise · Drug: HCTZ
Twice weekly centered based aerobic exercise + 3/week home-based walking
4 mg qd titrated to 8 mg qd perindopril
50 mg qd titrated to 100 qd losartan
12.5 mg qd titrated to 25 qd HCTZ
Change in Gait Speed From Baseline
Self-paced gait speed over 4m distance; change from baseline to week 32
Time frame: 32 weeks
| Milestone | Perindopril | Losartan | HCTZ |
|---|---|---|---|
| Started | 74 | 74 | 75 |
| Completed | 60 | 55 | 57 |
| Not completed | 14 | 19 | 18 |
Self-paced gait speed over 4m distance; change from baseline to week 32
| m/sec | Perindopril | Losartan | HCTZ |
|---|---|---|---|
| Change in Gait Speed From Baseline | 0.10 (-0.42 to 0.61) | 0.05 (-0.43 to 0.54) | 0.10 (-.28 to 0.47) |
Collected over 7 months of engagement in the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Perindopril | 0/74 (0%) | 2/74 (2.7%) | 32/74 (43.2%) |
| Losartan | 0/74 (0%) | 1/74 (1.4%) | 31/74 (41.9%) |
| HCTZ | 0/75 (0%) | 5/75 (6.7%) | 40/75 (53.3%) |
| Event | Perindopril | Losartan | HCTZ |
|---|---|---|---|
| HospitalizationGeneral disorders | 1/74 | 0/74 | 4/75 |
| OtherGeneral disorders | 1/74 | 1/74 | 1/75 |
| Event | Perindopril | Losartan | HCTZ |
|---|---|---|---|
| OtherGeneral disorders | 16/74 | 22/74 | 35/75 |
| Musculoskeletal, muscle pulls, strainsMusculoskeletal and connective tissue disorders | 16/74 | 9/74 | 15/75 |
| Age, Continuous(years) | Perindopril | Losartan | HCTZ | Total |
|---|---|---|---|---|
| Mean | 67.6 ± 4.9 | 67.9 ± 5.8 | 67.0 ± 4.9 | 67.5 ± 5.2 |
| Sex: Female, Male(Participants) | Perindopril | Losartan | HCTZ | Total |
|---|---|---|---|---|
| Female | 57 | 55 | 56 | 168 |
| Male | 17 | 19 | 19 | 55 |
| Race (NIH/OMB)(Participants) | Perindopril | Losartan | HCTZ | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 | 4 |
| Asian | 0 | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 27 | 31 | 23 | 81 |
| White | 45 | 38 | 48 | 131 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 2 | 1 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Perindopril · Losartan · Hydrochlorothiazide
University of Alabama at Birmingham →