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ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension (ACES)

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ClinicalTrials.gov Identifier: NCT03295734
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by (Responsible Party):
Thomas W. Buford, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Hypertension Aging Sedentary Lifestyle Behavioral: Aerobic exercise Drug: Perindopril Drug: Losartan Drug: HCTZ Phase 2

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. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ACES - ACE Inhibitors Combined With Exercise for Seniors With Hypertension
Actual Study Start Date : May 29, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Perindopril
4 mg qd titrated to 8 mg qd perindopril + aerobic exercise
Behavioral: Aerobic exercise
Twice weekly centered based aerobic exercise + 3/week home-based walking

Drug: Perindopril
4 mg qd titrated to 8 mg qd perindopril

Active Comparator: Losartan
50 mg qd titrated to 100 mg qd losartan + aerobic exercise
Behavioral: Aerobic exercise
Twice weekly centered based aerobic exercise + 3/week home-based walking

Drug: Losartan
50 mg qd titrated to 100 qd losartan

Active Comparator: HCTZ
12.5 mg qd titrated to 25 mg qd HCTZ + aerobic exercise
Behavioral: Aerobic exercise
Twice weekly centered based aerobic exercise + 3/week home-based walking

Drug: HCTZ
12.5 mg qd titrated to 25 qd HCTZ




Primary Outcome Measures :
  1. Gait speed [ Time Frame: 32 weeks ]
    Self-paced gait speed over 4m distance


Secondary Outcome Measures :
  1. Six minute walk test [ Time Frame: 32 weeks ]
    maximal distance covered over six minutes

  2. Body composition [ Time Frame: 32 weeks ]
    % body fat/lean mass collected via dual x-ray absorptiometry

  3. Circulating indices of cardiovascular risk [ Time Frame: 32 weeks ]
    TNF-α, IL-6, VCAM-1, E-selectin; oxidized LDL; myeloperoxidase



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 to communicate with primary care physician regarding changes in antihypertensive treatment

Exclusion Criteria:

  • Resistant hypertension, defined as 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 >5.0 mEq/L
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295734


Contacts
Contact: Thomas Buford, PhD 2059963008 twbuford@uabmc.edu

Locations
United States, Alabama
UAB Center for Exercise Medicine Recruiting
Birmingham, Alabama, United States, 35205
Contact: Sara Harper, PhD    205-996-3005    saharper@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
University of Colorado, Denver
Investigators
Principal Investigator: Thomas Buford, PhD University of Alabama at Birmingham
Principal Investigator: Wendy Kohrt, PhD University of Colorado, Denver

Responsible Party: Thomas W. Buford, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03295734     History of Changes
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Perindopril
Angiotensin-Converting Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors