A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

Overview

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.

Full Title of Study: “A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension (ATRAX Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2018

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: Sertraline
    • sertraline, 25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial
  • Placebo Comparator: Placebo
    • placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Olomouc
  • Collaborator
    • Brno University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jan Vaclavík, Jan Václavík, MD. Ph.D. Assoc. Prof. – Palacky University
  • Overall Official(s)
    • Jan Vaclavik, MD. Ph.D. Assoc. Prof, Study Chair, University Hospital Olomouc
  • Overall Contact(s)
    • Jan Vaclavik, MD. Ph.D. Assoc. Prof., +420588442682, janvaclavik@yahoo.com

References

Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma): understanding the cause and treatment. Arch Intern Med. 1999 Apr 12;159(7):670-4. doi: 10.1001/archinte.159.7.670.

Eisenhofer G, Sharabi Y, Pacak K. Unexplained symptomatic paroxysmal hypertension in pseudopheochromocytoma: a stress response disorder? Ann N Y Acad Sci. 2008 Dec;1148:469-78. doi: 10.1196/annals.1410.019.

Pickering TG, Clemow L. Paroxysmal hypertension: the role of stress and psychological factors. J Clin Hypertens (Greenwich). 2008 Jul;10(7):575-81. doi: 10.1111/j.1751-7176.2008.07844.x.

Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma). Curr Hypertens Rep. 2008 Feb;10(1):12-8. doi: 10.1007/s11906-008-0005-2.

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