A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

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.

Conditions

• Hypertension

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

Sponsors & Collaborators

• Brno University Hospital

  collaborator OTHER

• St. Anne

  collaborator UNKNOWN

• University Hospital Ostrava

  collaborator OTHER

• Tomas Bata Hospital, Czech Republic

  collaborator OTHER

• Prerov Hospital

  collaborator UNKNOWN

• Valasske Mezirici Hospital

  collaborator UNKNOWN

• Thomayer University Hospital

  collaborator OTHER

• Vsetin Hospital

  collaborator UNKNOWN

• University Hospital Olomouc

  lead OTHER

Principal Investigators

• Jan Vaclavik, MD. Ph.D. Assoc. Prof · University Hospital Olomouc

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-30

Primary Completion

2018-06-30

Completion

2018-12-31

FDA Drug

Yes