Trial Outcomes & Findings for ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension (NCT NCT03295734)

NCT ID: NCT03295734

Last Updated: 2025-07-22

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 223 participants
• Primary outcome timeframe: 32 weeks
• Results posted on: 2025-07-22

Participant Flow

**NOTE: Participants could be excluded for more than one reason** Excluded (n=274) • Not meeting inclusion criteria# (n=274) * No physical function limitation (n=107) * Active lifestyle (n=55) * Resistant hypertension (n=35) * Severe cardiac disease (n= 34) * Significant cognitive impairment (n=15) * No hypertension (n=13) * Uncontrolled hypertension (n=10) * Proteinuria> 1+ (n=8) * Other medical concern that precluded safe participation (n=65)

Participant milestones

Measure	Perindopril 4 mg qd titrated to 8 mg qd perindopril + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Perindopril: 4 mg qd titrated to 8 mg qd perindopril	Losartan 50 mg qd titrated to 100 mg qd losartan + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Losartan: 50 mg qd titrated to 100 qd losartan	HCTZ 12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking HCTZ: 12.5 mg qd titrated to 25 qd HCTZ
Overall Study STARTED	74	74	75
Overall Study COMPLETED	60	55	57
Overall Study NOT COMPLETED	14	19	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension

Baseline characteristics by cohort

Measure	Perindopril n=74 Participants 4 mg qd titrated to 8 mg qd perindopril + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Perindopril: 4 mg qd titrated to 8 mg qd perindopril	Losartan n=74 Participants 50 mg qd titrated to 100 mg qd losartan + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Losartan: 50 mg qd titrated to 100 qd losartan	HCTZ n=75 Participants 12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking HCTZ: 12.5 mg qd titrated to 25 qd HCTZ	Total n=223 Participants Total of all reporting groups
Age, Continuous	67.6 years STANDARD_DEVIATION 4.9 • n=5 Participants	67.9 years STANDARD_DEVIATION 5.8 • n=7 Participants	67.0 years STANDARD_DEVIATION 4.9 • n=5 Participants	67.5 years STANDARD_DEVIATION 5.2 • n=4 Participants
Sex: Female, Male Female	57 Participants n=5 Participants	55 Participants n=7 Participants	56 Participants n=5 Participants	168 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	55 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	31 Participants n=7 Participants	23 Participants n=5 Participants	81 Participants n=4 Participants
Race (NIH/OMB) White	45 Participants n=5 Participants	38 Participants n=7 Participants	48 Participants n=5 Participants	131 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants

PRIMARY outcome

Timeframe: 32 weeks

Population: Intent to Treat

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

Outcome measures

Measure	Perindopril n=74 Participants 4 mg qd titrated to 8 mg qd perindopril + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Perindopril: 4 mg qd titrated to 8 mg qd perindopril	Losartan n=74 Participants 50 mg qd titrated to 100 mg qd losartan + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Losartan: 50 mg qd titrated to 100 qd losartan	HCTZ n=75 Participants 12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking HCTZ: 12.5 mg qd titrated to 25 qd HCTZ
Change in Gait Speed From Baseline	0.10 m/sec Interval -0.42 to 0.61	0.05 m/sec Interval -0.43 to 0.54	0.10 m/sec Interval -0.28 to 0.47

Adverse Events

Perindopril

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Losartan

Serious events: 1 serious events

Other events: 31 other events

Deaths: 0 deaths

HCTZ

Serious events: 5 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Perindopril n=74 participants at risk 4 mg qd titrated to 8 mg qd perindopril + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Perindopril: 4 mg qd titrated to 8 mg qd perindopril	Losartan n=74 participants at risk 50 mg qd titrated to 100 mg qd losartan + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Losartan: 50 mg qd titrated to 100 qd losartan	HCTZ n=75 participants at risk 12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking HCTZ: 12.5 mg qd titrated to 25 qd HCTZ
General disorders Hospitalization	1.4% 1/74 • Number of events 1 • 7 months of engagement in the study	0.00% 0/74 • 7 months of engagement in the study	5.3% 4/75 • Number of events 4 • 7 months of engagement in the study
General disorders Other	1.4% 1/74 • Number of events 1 • 7 months of engagement in the study	1.4% 1/74 • Number of events 1 • 7 months of engagement in the study	1.3% 1/75 • Number of events 1 • 7 months of engagement in the study

Other adverse events

Measure	Perindopril n=74 participants at risk 4 mg qd titrated to 8 mg qd perindopril + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Perindopril: 4 mg qd titrated to 8 mg qd perindopril	Losartan n=74 participants at risk 50 mg qd titrated to 100 mg qd losartan + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking Losartan: 50 mg qd titrated to 100 qd losartan	HCTZ n=75 participants at risk 12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise Aerobic exercise: Twice weekly centered based aerobic exercise + 3/week home-based walking HCTZ: 12.5 mg qd titrated to 25 qd HCTZ
Musculoskeletal and connective tissue disorders Musculoskeletal, muscle pulls, strains	21.6% 16/74 • 7 months of engagement in the study	12.2% 9/74 • 7 months of engagement in the study	20.0% 15/75 • 7 months of engagement in the study
General disorders Other	21.6% 16/74 • 7 months of engagement in the study	29.7% 22/74 • 7 months of engagement in the study	46.7% 35/75 • 7 months of engagement in the study

Additional Information

Thomas W. Buford, PhD

UAB

Phone: 205-996-3008

Email: twbuford@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place