A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

Phase 4

• Conditions: Hypertension
• Interventions: Drug: Placebo; Drug: Sertraline

• Registration Number: NCT02641652
• Lead Sponsor: University Hospital Olomouc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-08
• Study Start: 2017-11
• Primary Completion: 2018-06
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo
Sertraline	Sertraline	sertraline, 25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial

Primary Outcome Measures

Name	Time	Method
difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups	3 months of treatment
difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups	3 months

Secondary Outcome Measures

Name	Time	Method
side effects of the treatment	3 months
difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups	3 months