Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01650402
Other study ID # 11-155S-2
Secondary ID 2R01AG022092-06A
Status Completed
Phase N/A
First received
Last updated
Start date December 2011
Est. completion date October 2018

Study information

Verified date October 2020
Source UConn Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The study patients will be enrolled and randomized to one of two levels of ambulatory BP control (intensive to achieve a goal 24-hour systolic BP of < 130 mmHg or standard to achieve a goal 24-hour systolic BP of < 145 mmHg) for a total of 36 months. Similar antihypertensive regimens will be used in both of the treatment groups. Titration of antihypertensive therapies will be performed at monthly intervals for the first 3 to 6 months post-randomization to achieve goal systolic BP. The primary and secondary outcomes will be evaluated at baseline, and following 18 months and 36 months of therapy.


Recruitment information / eligibility

Status Completed
Enrollment 199
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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).

Study Design


Intervention

Other:
Anti-hypertensive therapy to SBP 130 mm Hg
Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
Anti-hypertensive therapy to SBP 145 mm Hg
Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg

Locations

Country Name City State
United States University of Connecticut Health Center Farmington Connecticut

Sponsors (2)

Lead Sponsor Collaborator
UConn Health National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mobility - Measured by Change in Gait Speed Change in gait speed (walking 8 meters) in seconds mediated by the accrual of white-matter hyperintensity lesions (WMH/intracranial cavity volume) using MRI and including degeneration of axonal and myelin components of white matter using MRI technology known as diffusion tensor imaging (DTI). Change from baseline to 36 months
Secondary Cognitive Function - as Measured by Change in Stroop Test Score Change in cognitive function as measured by stroop test score: number of correct responses in 45 seconds.
The score for the Stroop Test is the number of correct responses provided in 45 seconds on each test condition: word reading, color naming, and inhibition. For the inhibition condition, words are written in an incongruous ink color (e.g., the word red written in blue ink) and participants must provide the ink color. Scores range from 0 to no upper limit, with higher scores indicating better performance.
Change from baseline to 36 months
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02248311 - "Preventing Cardiovascular Ischemic Events and Arresting Their Consequences in Type 2 Diabetic Population N/A
Completed NCT01604486 - Natural Ischaemic Preconditioning Before First Myocardial Infarction N/A
Active, not recruiting NCT00627029 - Evaluation of Programs of Coordinated Care and Disease Management N/A
Recruiting NCT04336852 - Development of a Clinically-relevant Test for Assessment of Cerebral Vascular Function N/A
Not yet recruiting NCT06429332 - International Care Bundle Evaluation in Cerebral Hemorrhage Research Phase 4
Not yet recruiting NCT05925699 - National Database of the Virtual Institute of Cerebrovascular Diseases
Recruiting NCT04443439 - Assess the Risk of Cerebrovascular Disease
Recruiting NCT04525144 - EGb 761 in the Syndrome of MCI With Concomitant CVD Phase 2
Completed NCT02553655 - Remote Ischemic Limb Preconditioning In Healthy Volunteers N/A
Recruiting NCT00385385 - RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease Phase 2
Recruiting NCT05247931 - Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study
Completed NCT02665585 - Plaque Prolapse Prevention Carotid Artery Stenting (3PCAS) N/A
Recruiting NCT05834673 - VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN) Phase 4
Recruiting NCT06115213 - The North Kynouria Project N/A
Recruiting NCT02730065 - Aerobic Dance Training in Small Vessel Disease N/A
Terminated NCT02440646 - Natural History of Coronary Atherosclerosis in Real-World Stable Chest Pain Patients Underwent Computed Tomography Angiography in Comparison With Invasive Multimodality Imaging
Completed NCT01924312 - Early Detection and Prevention of Mild Cognitive Impairment Due to Cerebrovascular Disease N/A
Completed NCT00333164 - Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis Phase 3
Not yet recruiting NCT06241482 - Safety and Efficacy of Enhanced Recovery After Surgery in Neurocritical Care N/A
Enrolling by invitation NCT02694094 - Impact of Ketogenic Diets on Cardiovascular Health in Adults With Epilepsy