ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension

Last updated: July 17, 2025
Sponsor: University of Alabama at Birmingham
Overall Status: Completed

Phase

2

Condition

Williams Syndrome

Circulation Disorders

Stress

Treatment

Perindopril

Aerobic exercise

Losartan

Clinical Study ID

NCT03295734
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 tocommunicate with primary care physician regarding changes in antihypertensivetreatment

Exclusion

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 upperlimit 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 cardiacdefibrillator, or uncontrolled angina

  • Acute myocardial infarction identified by ECG

  • Significant cognitive impairment, defined as a known diagnosis of dementia or aMini-Mental State Examination exam score < 24;

  • Simultaneous participation in another intervention trial

  • Known hypersensitivity to ACE inhibitors (exclusion only to perindopril arm; will berandomized among other two interventions)

  • Any other condition that would preclude participating based upon judgement of PI orstudy clinician team

Study Design

Total Participants: 223
Treatment Group(s): 4
Primary Treatment: Perindopril
Phase: 2
Study Start date:
May 29, 2018
Estimated Completion Date:
September 19, 2024

Study 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.

Connect with a study center

  • UAB Center for Exercise Medicine

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • University of Colorado Medical Center

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Translational Research Institute

    Orlando, Florida 32804
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.