INFINITY 2013

Trial name or title	INFINITY Study
Methods	Prospective, randomized, open‐label trial with blinded endpoints (PROBE design). The expected mean follow‐up was 4 years
Participants	Men and women aged ≥ 75 years with SBP > 150 mmHg (untreated state) and at risk for cerebrovascular disease (history of smoking, dyslipidaemia, type 2 diabetes, long standing hypertension, family history). Participants had visible (≥ 0.5%) white matter hyper intensities lesions on cerebral MRI screening. To be eligible for inclusion, participants needed to maintain 24 hour SBP < 145 mmHg in the standard treatment group or SBP < 130 mmHg in the intensive treatment group if the clinical SBP was 150 to 170 mmHg and taking 0 to 2 antihypertensives, or SBP was > 170 mmHg and taking 0 to 1 antihypertensives. Exclusion criteria included uncontrolled diabetes mellitus (HBA1c > 10%), history of stroke, dementia, or clinically impaired gait, body mass index > 45 kg/m² and/or arm circumference > 44 cm), poor kidney function, active liver disease or serum transaminases > 3 times the upper limit of normal, major cardiovascular event (e.g. MI) or procedure (e.g. CABG surgery) in past 3 months, uncompensated CHF, or chronic atrial fibrillation that disallows ambulatory blood pressure monitoring to be successfully performed
Interventions	Standard target: 24 h SBP < 145 mmHg Intensive target: 24 h SBP < 130 mmHg
Outcomes	Primary outcome measures: change from baseline in mobility parameters (self‐paced walk and stance times), at 18 months and at 36 months; and change from baseline in cognitive function (executive function, processing speed), at 18 months and at 36 months. Secondary outcome measures: Accrual of white matter hyperintensity over 36 months including degeneration of tissue and tissue perfusion. Adverse events, tolerability, and health‐related quality of life were also to be evaluated
Starting date	December 2011
Contact information	William B White, MD, Division of Hypertension and Clinical Pharmacology, Calhoun Cardiology Center, University of Connecticut School of Medicine, 263 Farmington Ave, Farmington, CT 06030‐3940 USA. E‐mail: wwhite@nso1.uchc.edu
Notes	Sponsored by the National Institute of Aging