Trial | NCT02641652  Report issue

Title

A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension
A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension (ATRAX Trial)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    sertraline ...

  • Study Participants

    136
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 Started
Nov 30
2017
Anticipated
Primary Completion
Jun 30
2018
Anticipated
Study Completion
Dec 31
2018
Anticipated
Last Update
Sep 08
2017

Drug Sertraline

25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial

Drug Placebo

1/2 tablet once daily for first 7 days, then 1 tablet once daily for the rest of the trial

Sertraline Active Comparator

sertraline, 25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial

Placebo Placebo Comparator

placebo

Criteria 

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).
No Results Posted