A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension
A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension
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.
Inclusion Criteria:

 Study will enroll adult patients (age >18 years) with hypertensive paroxysms during the
 past 6 months (preferably during the past 6 weeks) - abrupt elevations of systolic blood
 pressure (BP) ≥20% compared to previous measured systolic BP value before paroxysm, or ≥20%
 compared to mean systolic BP on 24-hour ambulatory blood pressure monitoring (ABPM), or
 ≥20% compared to measured office systolic BP, documented by a clinician or home blood
 pressure monitor, requiring physician or emergency room visit or the use of any rescue
 antihypertensive medication. Hypertensive paroxysms may be accompanied by abrupt onset of
 one or more distressful physical symptoms, such as headache, chest pain, dizziness, nausea,
 palpitations, flushing, and diaphoresis.

 Exclusion Criteria:

 Pregnancy or breastfeeding, hypersensitivity to sertraline (Zoloft®) or of the the
 components of this drug. Current use of sertraline or any other selective serotonin
 reuptake inhibitor (SSRI), mono-amin oxidase (MAO) inhibitors, selegiline, moclobemide,
 linezolide, pimozide. Current use of other serotoninergic drugs (eg. tryptofane, triptane
 and other 5-HT agonists), tramadol or dopamine antagonists (including antipsychotics).