Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 75 - Any |
| Updated: | 2/14/2018 |
| Start Date: | December 2011 |
| End Date: | September 2018 |
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.
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.
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).
We found this trial at
1
site
263 Farmington Ave
Farmington, Connecticut 06030
Farmington, Connecticut 06030
(860) 679-2000
University of Connecticut Health Center UConn Health is a vibrant, integrated academic medical center that...
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