Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People

• Status: Active, not recruiting
• Trial end date: 0000-00-00
• Target enrollment: 199
• Participant gender: Both

Summary

This study will evaluate different treatment strategies for high blood pressure using medications approved by the US Food and Drug Administration (FDA) for the treatment of high blood pressure. The study will compare the effects of an intensive reduction of 24-hour average blood pressure to a standard reduction of 24-hour mean blood pressure on controlling declines in mobility (speed and agility of walking) and cognition (ability to think and process information) in an aging population.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UConn Health
• Collaborator: National Institute on Aging (NIA)
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Calcium Channel Blockers
• Last Updated: 2016-12-14

Criteria

Inclusion Criteria:

• 75 years of age or older

• Seated clinic systolic BP >150 mmHg in the untreated state (see criterion D)

• At risk for cerebrovascular disease (history of smoking, dyslipidemia, type 2 diabetes, longstanding hypertension, family history). Patients must have visible (0.5% WMH or more)white-matter hypertensity lesions on screening magnetic resonance imaging

• To achieve success in maintaining a 24-hour systolic BP of <140-145 mmHg in the standard treatment group or a systolic BP <125-130 mmHg in the intensive treatment group, patients will be eligible for inclusion if (1) their clinic systolic BP is 150-170 mmHg, and they are taking 0 to 2 antihypertensives, (2) their systolic BP is >170 mmHg and they are taking 0 to 1 antihypertensives

Exclusion Criteria:

• Uncontrolled diabetes mellitus (HBA1c >10%)

• History of stroke, dementia or clinically impaired gait (Mini-mental status exam score (MMSE) <24, Short Physical Performance Battery for gait (SPPB) < 9,)

• Body Mass Index > 45 kg/m2 and/or arm circumference > 44 cm)

• Poor kidney function (defined as estimated GFR <30 ml/minute)

• Active liver disease or serum transaminases >3 times the upper limit of normal

• Major cardiovascular event (e.g. myocardial infarction) or procedure (e.g. cardiac bypass surgery) in past 3 months; stroke with residual gait abnormality

• Uncompensated congestive heart failure (NYHA class III or IV or documented ejection fraction <30%)

• Chronic atrial fibrillation that disallows ambulatory BP monitoring to be successfully performed

• Medical conditions that limit survival to < 3 years

• Non-dermatologic cancer diagnosed within 2 years

• Organ transplantation requiring anti-rejection drug therapy

• Severe and unexplained weight loss (>15%) in past 6 months

• Medical need to undergo recurrent phlebotomy or blood transfusions

• Current participation in another investigational trial

• Unable to obtain informed consent

• Factors limiting adherence to the interventions

• MRI contraindications (including MRI-incompatible implants, severe claustrophobia).