Back to results

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

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sertraline

Placebo

About this trial

This is an interventional treatment trial for Hypertension focused on measuring paroxysmal hypertension, pseudopheochromocytoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sertraline

Placebo

Arm Description

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

placebo

Outcomes

Primary Outcome Measures

difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups

difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups

Secondary Outcome Measures

difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups

side effects of the treatment

Full Information

NCT ID

NCT02641652

First Posted

December 22, 2015

Last Updated

September 5, 2017

Sponsor

University Hospital Olomouc

Collaborators

Brno University Hospital, St. Anne, University Hospital Ostrava, Tomas Bata Hospital, Czech Republic, Prerov Hospital, Valasske Mezirici Hospital, Thomayer University Hospital, Vsetin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02641652

Brief Title

A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

Acronym

ATRAX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 2017 (Anticipated)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital Olomouc

Collaborators

Brno University Hospital, St. Anne, University Hospital Ostrava, Tomas Bata Hospital, Czech Republic, Prerov Hospital, Valasske Mezirici Hospital, Thomayer University Hospital, Vsetin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

paroxysmal hypertension, pseudopheochromocytoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sertraline

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

Sertraline

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

difference in the rate of paroxysmal hypertension symptoms cessation between sertraline and placebo groups

Time Frame

3 months of treatment

Title

difference in the rate of paroxysmal hypertension symptoms reduction between sertraline and placebo groups

Time Frame

3 months

Secondary Outcome Measure Information:

Title

difference in the fall of mean office and ambulatory systolic and diastolic blood pressure between groups

Time Frame

3 months

Title

side effects of the treatment

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jan Vaclavik, MD. Ph.D. Assoc. Prof.

Phone

+420588442682

janvaclavik@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Irena Opavska, Bc.

Phone

+420588443716

irena.opavska@fnol.cz

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Vaclavik, MD. Ph.D. Assoc. Prof

Organizational Affiliation

University Hospital Olomouc

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10218745

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.

Results Reference

background

PubMed Identifier

19120143

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.

Results Reference

background

PubMed Identifier

18607143

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.

Results Reference

background

PubMed Identifier

18367021

Citation

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

Results Reference

background

Links:

URL

http://www.fnol.cz

Description

University Hospital Olomouc

URL

http://www.lf.upol.cz/en/

Description

Faculty of Medicine and Dentistry, Palacký University

Learn more about this trial

A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

We'll reach out to this number within 24 hrs