A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

NCT02641652 | Unknown Phase 4 FDA Drug

• 1 other identifier: ATRAX
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

paroxysmal hypertension; pseudopheochromocytoma

Outcome Measures

Primary Outcomes (2)

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

  3 months of treatment

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

  3 months

Secondary Outcomes (2)

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

  3 months

• side effects of the treatment

  3 months

Study Arms (2)

Sertraline

ACTIVE COMPARATOR

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

Drug: Sertraline

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Sertraline DRUG

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

Sertraline

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Brno University Hospital: collaborator
• St. Anne: collaborator
• University Hospital Ostrava: collaborator
• Tomas Bata Hospital, Czech Republic: collaborator
• Prerov Hospital: collaborator
• Valasske Mezirici Hospital: collaborator
• Thomayer University Hospital: collaborator
• Vsetin Hospital: collaborator

Related Publications (4)

• 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.

  PMID: 10218745 BACKGROUND

• 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.

  PMID: 19120143 BACKGROUND

• 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.

  PMID: 18607143 BACKGROUND

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

  PMID: 18367021 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Hypertension

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Jan Vaclavik, MD. Ph.D. Assoc. Prof

  University Hospital Olomouc

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+420588442682; janvaclavik@yahoo.com

Irena Opavska, Bc.

CONTACT

+420588443716; irena.opavska@fnol.cz

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jan Václavík, MD. Ph.D. Assoc. Prof.

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 29, 2015
• Study Start: November 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 8, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share