There is currently no established treatment for paroxysmal hypertension, but selective serotonin reuptake inhibitors showed good effect in previous reports. This double-blind, placebo controlled, prospective multicenter clinical trial will assess the efficacy of sertraline on cessation or reduction of symptoms of paroxysmal arterial hypertension. 136 patients with documented hypertensive paroxysms with abrupt elevations of blood pressure and distressful physical symptoms will be randomized in a 1:1 ratio to receive sertraline, 50 mg daily, or matching placebo as an add-on to their chronic medication. Effect of the treatment on patient symptoms, office and ambulatory blood pressure and side effects will be evaluated after 3 months. If proven effective, sertraline might become a standard treatment for this condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
136
25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial
1/2 tablet once daily for first 7 days, then 1 tablet once daily for the rest of the trial
difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups
Time frame: 3 months of treatment
difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups
Time frame: 3 months
difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups
Time frame: 3 months
side effects of the treatment
Time frame: 3 months
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