Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Completed · Not applicable
Conditions studied: Hypertension, Systolic, Cerebrovascular Disease
In brief
This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to \<130 mmHg (intensive control) versus \<145 mmHg (standard control) slows/halts the progression of deterioration of mobility and cognitive function linked to white-matter disease (also known as white-matter hyperintensity or WMH) in patients with normal or mildly impaired mobility and cognition in subjects with detectable cerebrovascular disease (\>0.5% WMH fraction of intracranial contents). The study patients will be enrolled and randomized to one of two levels of ambulatory blood pressure control (intensive to achieve a goal 24-hour systolic blood pressure of \< 130 mmHg or standard to achieve a goal 24-hour systolic blood pressure of \< 145 mmHg) for a total of 36 months.
Key facts
- Study ID
- NCT01650402
- Run by
- UConn Health
- People needed
- 199
- Starts
- 2011-12-01
- Expected to finish
- 2018-10-01
- Last updated by the study team
- 2020-11-18
Who can join
Age: 75 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- University of Connecticut Health Center — Farmington, Connecticut, United States
Full record on ClinicalTrials.gov
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