N/A
N=199
Intensive Versus Standard Blood Pressure Lowering to Prevent Functional Decline in Older People
Hypertension, Systolic · Cerebrovascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT01650402 ↗Enrolled (actual)
199
Serious AEs
34.7%
Results posted
Oct 2020
Primary outcome: Primary: Mobility - Measured by Change in Gait Speed — 0.4; 0.42 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anti-hypertensive therapy to SBP 130 mm Hg (Other); Anti-hypertensive therapy to SBP 145 mm Hg (Other)
- Age
- Older Adult · 75+ yrs
- Sex
- All
- Sponsor
- UConn Health
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mobility - Measured by Change in Gait Speed |
0.4; 0.42 | — |
| SECONDARY Cognitive Function - as Measured by Change in Stroop Test Score |
-2.7; -0.8 | — |
Summary
This randomized clinical trial examines if lowering and maintaining 24-hour ambulatory systolic blood pressure to 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.
Eligibility 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 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) 45 kg/m2 and/or arm circumference > 44 cm)
- Poor kidney function (defined as estimated GFR 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 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).
Data sourced from ClinicalTrials.gov (NCT01650402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.