“TROPHY,” Trial of Preventing Hypertension   Sponsor     Astra-Zeneca   Berman Center Site Investigators     Principal Investigator: Henry Smith, MD, Hennepin Faculty Associates   Berman Center Site Coordinator     Shirley Conn, RN 612-341-7909   Description     Individuals with untreated, high-normal blood pressure (130 mmHg ≤ SBP ≤ 139 mmHg and/or 85 mmHg ≤ DBP ≤ 89 mmHg) are believed to be at elevated risk for developing more severe hypertension and its cardiovascular disease complications. This multi-site, placebo-controlled, double-blinded trial investigates the efficacy of Candesartan for lowering blood pressure in such individuals.   Role of the Berman Center     The Berman Center enrolled 10 participants between August 1999 and October 2000. Participants visited the Berman Center every three months for four years to provide blood pressure measurements and complete adverse event questionnaires. Every two years, a Berman Center study physician conducted a physical examination; every year, Berman Center laboratory technicians drew blood for a complete panel analysis. Four participants completed the trial by December 1, 2003; the others are expected to complete the trial by Fall 2004.   Abstract     Individuals with untreated, high-normal blood pressure (130 mmHg ≤ SBP ≤ 139 mmHg and/or 85 mmHg ≤ DBP ≤ 89 mmHg) are believed to be at elevated risk for developing more severe hypertension and its cardiovascular disease complications. This trial is being conducted at 60 sites throughout the U.S., and has enrolled 700 participants. Participants must have “high-normal BP”, defined as (130 mmHg ≤ SBP ≤ 139 mmHg and/or 85 mmHg ≤ DBP ≤ 89 mmHg), must not be taking any antihypertensive medication, and must not have a history of cardiovascular disease and/or diabetes mellitus. They are randomized to receive either Candesartan or placebo for four years, providing BP measurements every three months during that time. The endpoints of interest are: 1) SBP > 189 mmHg at least three times and/or DBP > 89 mmHG at least three times; 2) fatal or non-fatal CVD event; 3) Diagnosis of Type II Diabetes. If a participant exceeds the BP limits at least three times, he or she is placed on an open-label adjunct therapy, while blinded treatment with study medication continues.