A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

Hypertension Clinical Trial

— ATRAX  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02641652
• Other study ID #: ATRAX
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 22, 2015
• Last updated: September 5, 2017
• Start date: November 2017
• Est. completion date: December 2018

Study information

• Verified date: September 2017
• Source: University Hospital Olomouc
• Contact: Jan Vaclavik, MD. Ph.D. Assoc. Prof.
• Phone: +420588442682
• Email: janvaclavik[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Sertraline
25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial
• Placebo
1/2 tablet once daily for first 7 days, then 1 tablet once daily for the rest of the trial

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
University Hospital Olomouc	Brno University Hospital, Prerov Hospital, St. Anne, Thomayerova Teaching Hospital, Tomas Bata Hospital, Czech Republic, University Hospital Ostrava, Valasske Mezirici Hospital, Vsetin Hospital

References & Publications (5)

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. — View Citation

Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma). Curr Hypertens Rep. 2008 Feb;10(1):12-8. Review. — View Citation

Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma): understanding the cause and treatment. Arch Intern Med. 1999 Apr 12;159(7):670-4. Review. — View Citation

Pickering TG, Clemow L. Paroxysmal hypertension: the role of stress and psychological factors. J Clin Hypertens (Greenwich). 2008 Jul;10(7):575-81. Review. — View Citation

Vaclavik J, Krenkova A, Kocianova E, Vaclavik T, Kamasova M, Taborsky M. 7B.04: EFFECT OF SERTRALINE IN PAROXYSMAL HYPERTENSION. J Hypertens. 2015 Jun;33 Suppl 1:e93. doi: 10.1097/01.hjh.0000467601.49032.62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups		3 months of treatment
Primary	difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups		3 months
Secondary	difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups		3 months
Secondary	side effects of the treatment		3 months

External Links

•   Faculty of Medicine and Dentistry, Palacký University
•   University Hospital Olomouc