ACE Inhibitors Combined With Exercise for Seniors - Pilot Study (ACES-P)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Florida
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01891513
First received: June 24, 2013
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to compare, when combined with chronic exercise, the effects of perindopril, losartan, and hydrochlorothiazide.


Condition Intervention Phase
Hypertension
Aging
Behavioral: Exercise
Drug: ACE inhibitor + exercise
Drug: Thiazide diuretic + exercise
Drug: Angiotensin receptor blocker + exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multimodal Intervention to Reduce Cardiovascular Risk Among Hypertensive Older Adults

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change in Walking Speed [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Investigators will assess walking speed by asking the participants to walk at their usual pace over a 4 m course. Participants will be instructed to stand with both feet touching the starting line and to start walking after a specific verbal command.


Secondary Outcome Measures:
  • Change in body composition [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Changes in skeletal muscle and adipose tissue (by modulating cardiometabolic function)both fat mass and fat-free mass (FFM) will be assessed using dual energy x-ray absorptiometry (DEXA).

  • Changes in circulating indices of cardiovascular risk [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Fasting blood samples (serum or plasma as appropriate) will be evaluated for blood lipids, glucose, and hemoglobin A(1c) levels. Samples will also be used to assay for prominent markers of inflammation (e.g. Tumor necrosis factor-α (TNF-α), Interleukin 6 (IL-6), Vascular cell adhesion protein 1 (VCAM-1), E-selectin) and oxidative stress, including oxidized LDL and myeloperoxidase (MPO).

  • Change in Exercise Capacity [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Investigators will assess exercise capacity of participants using the six-minute (6-min) walk test, a safe and reliable test of aerobic endurance in older persons and those with cardiovascular conditions.


Estimated Enrollment: 72
Study Start Date: January 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACE inhibitor + exercise
In addition to exercise training, participants will receive an initial perindopril dose of 2 mg/day which will be titrated to 4 mg/day.
Behavioral: Exercise
All participants will take part in 3 days/week of structured aerobic, stretching, and balance training for weeks 1-12. For weeks, 13-24, training will be reduced to 2 days/week and a resistance training component added. Participants will also be expected to engage in 2 bouts of 30 minutes of home-based walking per week.
Drug: ACE inhibitor + exercise
In addition to exercise training, participants will receive an initial perindopril dose of 2 mg/day which will be titrated to 4 mg/day.
Other Name: Perindopril
Experimental: Thiazide diuretic + exercise
In addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day.
Behavioral: Exercise
All participants will take part in 3 days/week of structured aerobic, stretching, and balance training for weeks 1-12. For weeks, 13-24, training will be reduced to 2 days/week and a resistance training component added. Participants will also be expected to engage in 2 bouts of 30 minutes of home-based walking per week.
Drug: Thiazide diuretic + exercise
In addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day.
Other Name: Hydrochlorothiazide
Experimental: Angiotensin receptor blocker + exercise
In addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day.
Behavioral: Exercise
All participants will take part in 3 days/week of structured aerobic, stretching, and balance training for weeks 1-12. For weeks, 13-24, training will be reduced to 2 days/week and a resistance training component added. Participants will also be expected to engage in 2 bouts of 30 minutes of home-based walking per week.
Drug: Angiotensin receptor blocker + exercise
In addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day.
Other Name: Losartan

Detailed Description:

An initial telephone screening will indicate eligibility to participate in the study. The first study visit ("Screening visit") will further determine eligibility to participate. If eligible to fully participate, this study will consist of a structured physical activity program for 24 weeks. In addition, taking daily medication to control your blood pressure and coming to the clinic for several additional assessment visits to monitor your safety and measure study outcomes.

This physical activity program will include moderate-intensity walking, lower-body strengthening, flexibility, and balance training. For the first 12 weeks, of participation there will be three (3) physical activity sessions per week at the physical activity center. These sessions will be led by investigators study staff. These sessions will be used to begin the walking program and to introduce the participant to the strength, stretching, and balance parts of the program in a safe manner. This will allow instructors to better tailor the program to individual needs and abilities. These sessions will involve 40-60 minutes of physical activity instruction. For the final 12 weeks of the intervention, there will be two (2) of these sessions per week.

Participants will also be engage in home-based walking twice per week. This walking can be done at home, community-based physical activity centers (YMCA, senior centers, churches, etc.), or other appropriate facilities as desired. Participants will be asked to report the number of minutes walked each week.

Participants will be randomly assigned to take one of three medications to continue treating blood pressure. These medications are Perindopril, Losartan, and Hydrochlorothiazide. Each medication represents a separate type medication commonly used in practice. These medications are all standard, FDA-approved medications for the treatment of blood pressure. During the time of participating in the study, the use of the normal blood pressure medication will be replaced with the medication assigned during the study. The medications will be inserted into identical capsules by the study pharmacy so that neither participants nor the investigators will know which medication is being used.

Study staff will monitor blood pressure during the study under the supervision of a board-certified cardiologist, and any necessary adjustments to the medication will be indicated by the physician. Participants will also be provided with a blood pressure monitor to use at home during the study and asked to check blood pressure each day and report any abnormal values to study staff. This monitor also automatically records each blood pressure reading. Please bring this monitor to each assessment visit so that study staff can download the stored blood pressure readings.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 65 years and older
  • Hypertension - untreated (Systolic Blood Pressure (SBP) ≥ 140 mm Hg or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg) or treated with ≤ 2 antihypertensive drugs
  • Physical limitations evidenced by either:

Score ≤ 10 on the Short Physical Performance Battery OR Walking speed < 1.0 m/sec during 400 m usual-paced test

  • Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire
  • Willingness to participate in all study procedures

Exclusion Criteria:

  • Failure to provide informed consent
  • Inability to complete 400 m walk within 15 minutes without sitting or interpersonal assistance, as an indicator of disablement and likely inability to fully engage in the exercise intervention
  • Primary indication for ACE inhibitor use, i.e. Congestive Heart Failure, CAD, diabetes
  • Known hypersensitivity to ACE inhibitors
  • Treatment with 3 or more antihypertensive drugs
  • Office or average home SBP > 180 mm Hg or DBP > 110 mm Hg (Average home BP in any seven day period during trial)
  • Primary renal disease
  • Serum creatinine >2.5 mg/dL in men, or >2.0 mg/dL in women
  • Serum potassium >5.0 molar equivalent/L
  • Urinary protein > 1 on dipstick
  • Abnormal liver enzymes (Aspartate transaminase (AST), Alanine transaminase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal)
  • Severe cardiac disease, including New York Heart Association 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
  • Lives in a nursing home (persons living in assisted or independent housing will not be excluded)
  • Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental State Examination exam score < 24
  • Unable to communicate because of severe hearing loss or speech disorder
  • Severe visual impairment, which would preclude completion of the assessments and/or intervention
  • Other significant co-morbid disease that would prevent participation in exercise
  • Planning to move out of the area during the study time frame
  • Simultaneous participation in another intervention trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891513

Contacts
Contact: Thomas Buford, Ph.D. 352-273-5918 tbuford@ufl.edu
Contact: Megan Lorow 352-294-5090 mlorow@ufl.edu

Locations
United States, Florida
UF Institute on Aging Clinical and Translational Research Building Recruiting
Gainesville, Florida, United States, 32611
Contact: Thomas Buford, Ph.D.    352-273-5918    tbuford@ufl.edu   
Contact: Megan Lorow    352-273-9212    mlorow@ufl.edu   
Principal Investigator: Thomas Buford, Ph.D.         
Sub-Investigator: Stephen Anton, Ph.D.         
Sub-Investigator: Anthony Bavry, M.D.         
Sub-Investigator: Christy Carter, Ph.D.         
Sub-Investigator: Michael Marsiske, Ph.D.         
Sub-Investigator: Marco Pahor, M.D.         
Sub-Investigator: Bhanuprasad Sandesara, M.D.         
Sponsors and Collaborators
University of Florida
American Heart Association
Investigators
Principal Investigator: Thomas Buford, Ph.D. University of Florida Department of Aging and Geriatric Research
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01891513     History of Changes
Other Study ID Numbers: 099-2013, 13SDG17080033
Study First Received: June 24, 2013
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

Keywords provided by University of Florida:
Physical activity
Hypertension
Physical function
Aging

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Perindopril
Diuretics
Hydrochlorothiazide
Sodium Chloride Symporter Inhibitors
Losartan
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Natriuretic Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers

ClinicalTrials.gov processed this record on August 27, 2014