Clinical trial NCT02641652: A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension
Official title: A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension (ATRAX Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: paroxysmal hypertension
pseudopheochromocytoma
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
name: St. Anne
name: University Hospital Ostrava
name: Tomas Bata Hospital, Czech Republic
name: Prerov Hospital
name: Valasske Mezirici Hospital
name: Thomayer University Hospital
name: Vsetin Hospital
First posted: 2015-12-29
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups
timeFrame: 3 months of treatment
measure: difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups
timeFrame: 3 months
Secondary outcomes:
measure: difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups
timeFrame: 3 months
measure: side effects of the treatment
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Olomouc
name: Jan Vaclavik, MD. Ph.D. Assoc. Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Mann SJ. Severe paroxysmal hypertension (pseudopheochromocytoma). Curr Hypertens Rep. 2008 Feb;10(1):12-8. doi: 10.1007/s11906-008-0005-2.