ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension

NCT03295734 | Completed Phase 2 Results DMC FDA Drug

• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hypertension; Aging; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

• Change in Gait Speed From Baseline

  Self-paced gait speed over 4m distance; change from baseline to week 32

  32 weeks

Study Arms (3)

Perindopril

ACTIVE COMPARATOR

4 mg qd titrated to 8 mg qd perindopril + aerobic exercise

Behavioral: Aerobic exercise; Drug: Perindopril

Losartan

ACTIVE COMPARATOR

50 mg qd titrated to 100 mg qd losartan + aerobic exercise

Behavioral: Aerobic exercise; Drug: Losartan

HCTZ

ACTIVE COMPARATOR

12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise

Behavioral: Aerobic exercise; Drug: HCTZ

Interventions

Aerobic exercise BEHAVIORAL

Twice weekly centered based aerobic exercise + 3/week home-based walking

HCTZ; Losartan; Perindopril

Perindopril DRUG

4 mg qd titrated to 8 mg qd perindopril

Perindopril

Losartan DRUG

50 mg qd titrated to 100 qd losartan

Losartan

HCTZ DRUG

12.5 mg qd titrated to 25 qd HCTZ

HCTZ

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Colorado, Denver: collaborator
• AdventHealth Translational Research Institute: collaborator

Study Sites (2)

UAB Center for Exercise Medicine

Birmingham, Alabama, 35205, United States

Location

Translational Research Institute

Orlando, Florida, 32804, United States

Location

Related Publications (1)

• 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.

  PMID: 32039215 DERIVED

MeSH Terms

Conditions

Hypertension; Sedentary Behavior

Interventions

Exercise; Perindopril; Losartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides

Results Point of Contact

• Title: Thomas W. Buford, PhD
• Organization: UAB

twbuford@gmail.com

205-996-3008

Study Officials

• Thomas Buford, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Bret Goodpaster, PhD

  Translational Research Institute, Advent Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 28, 2017
• Study Start: May 29, 2018
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: July 22, 2025
• Results First Posted: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)