A substantial proportion (probably 30-40%) of elderly persons are being treated with BP medications. The efficacy of BP drug therapy in older patients with diastolic or combined diastolic/systolic hypertension is well proven, but there is little doubt that such therapy can adversely effect quality of life and the biochemical profile. There is a compelling rationale to (1) identify what proportion of medicated, well-controlled elderly hypertensives can be maintained (long-term less than 30 months) in the normotensive state following withdrawal of BP medications, and (2) determine whether non-pharmacologic therapy can significantly increase the proportion with successful outcome.

Nine-hundred subjects (225 in each of four centers) 65-80 years with a SBP less than 160 and DBP less than 90 mmhg while receiving one BP medication will be enrolled in a trial to test the efficacy of weight loss and sodium restriction (alone and combined) in maintaining the normotensive state-following withdrawal of antihypertensive medication. 600 overweight participants will be randomly assigned to weight loss, sodium restriction, combined weight loss and sodium restriction, or attention control. 300 non-overweight participants will be randomly assigned to a sodium restriction or attention control group. Withdrawal of antihypertensive medications will be attempted following 6 weeks of intervention. The primary trial endpoint will be needed for recurrent antihypertensive drug therapy. Our findings may identify a non-pharmacologic approach that provides a safe and well tolerated method by which to discontinue antihypertensive drug therapy in the approximately 15 million persons greater than or equal to 65 years who are currently being treated with BP medications. In addition, our study will identify the proportion of elderly hypertensives who can be maintained in the normotensive state without any intervention following withdrawal from their BP medications.

A multidisciplinary team will function as the Data Coordinating Center (DCC) for this trial. It includes expertise in biostatistics, nutrition, data management, cardiovascular disease, epidemiology and the design, implementation and evaluation of clinical trials. This team will collaborate with other investigators in developing the study protocol and manuals, developing and monitoring quality control, training, reporting, and analyzing and publishing study results. Clinic data will be collected using a distributed data entry system. Excellent facilities exist for the DDC.

R01AG009773

1991-09-30

1997-02-27