Hypertension Clinical Trial
To test the efficacy of weight loss and sodium restriction, alone and combined, in maintaining the normotensive state following withdrawal of antihypertensive medications in an elderly cohort. Conducted in collaboration with the National Institute on Aging.
BACKGROUND:
An estimated 30 to 40 percent of elderly persons are treated with blood pressure
medications. The efficacy of blood pressure drug therapy in older patients with diastolic or
combined diastolic/systolic hypertension is well proven, but such therapy can adversely
affect quality of life and biochemical profile. In 1992 when the study started, there was a
compelling rationale to identify what proportion of medicated, well-controlled elderly
hypertensives could be maintained long-term or greater than 30 months in the normotensive
state following withdrawal of blood pressure medications. There was also a need to determine
whether nonpharmacologic therapy could significantly increase the proportion with a
successful outcome.
DESIGN NARRATIVE:
Randomized. A total of 585 overweight subjects were assigned in a 2 x 2 factorial design to
weight loss, sodium reduction, combined weight loss and sodium reduction, or usual
life-style control. The remaining 390 subjects of normal weight were assigned in a 2-armed
design to a sodium reduction or an attention control group. The control groups were engaged
in a series of non-blood pressure related health encounters designed to control for
non-specific effects of groups contacts. Withdrawal of antihypertensive medication was
attempted following three months of intervention. The primary endpoint was a blood pressure
of 150/90 mm Hg or greater, resumption of antihypertensive drug therapy, or the occurrence
of a blood pressure-related clinical complication during two to three years of follow-up.
Recruitment ended in June, 1994. Follow-up ended in December, 1995. NHLBI support for the
trial ended in March, 1997. The NIA supported the Coordinating Center and two clinical
centers through February 1998.
The study completion date listed in this record was obtained from the "Completed Date"
entered from the old format in the Protocol Registration and Results System (PRS).
;
Allocation: Randomized, Intervention Model: Factorial Assignment, Primary Purpose: Treatment
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