Stop Vasodepressor Drugs in Reflex Syncope (STOP-VD)

December 28, 2015 updated by: Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope

Investigate clinical effects (reduction of number of syncope and associate symptoms) of suspension of vasoactive drugs in patients affected by vasodepressor reflex syncope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Several drugs which are commonly used in clinical practice, such as antihypertensive, antiarrhythmic and psychiatric drugs, are associated with orthostatic hypotension and syncope. This phenomenon is much more evident in the elderly and with multiple therapies. The present study was aimed to investigate, in patients affected by reflex syncope, the clinical effects (reduction in syncope recurrence and associated symptoms) and the laboratory tests (negativization of carotid sinus massage and tilt table test) when such drugs are discontinued or reduced

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Lavagna, Italy, 16032
        • Dipartimento di Cardiologia, Ospedali del Tigullio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients assuming chronic (>1 year) vasoactive therapy affected by reflex recurrent (>2 episodes) syncopes who have a positive dominant vasodepressor or mixed response to tilt table test and/or carotid sinus massage

Exclusion Criteria:

  1. Orthostatic hypotension defined as fall in systolic blood pressure >20 mmHg during the first 3 minutes of active standing
  2. Competing diagnosis of syncope different from hypotensive reflex syncope
  3. Reflex syncope with negative response to carotid sinus massage and tilt table test
  4. Cardioinhibitory reflex syncope which requires permanent cardiac pacing
  5. Severe hypertension which requires treatment (>150/95)
  6. Structured heart disease which requires hypotensive therapy in order to prevent acute heart failure
  7. Cardiac hypotensive therapy in order to prevent recurrences
  8. Previous stroke or transient ischemic attacks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stop/reduce vasoactive drugs
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment
Other: Stop/reduce vasoactive drugs
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.
Other Names:
  • Diuretics
  • Nitrates
  • Antihypertensive
  • Alpha-antagonists
  • Neuroleptic antidepressant
  • L-dopa antagonists
Experimental: Vasoactive drug therapy
Continue current vasoactive therapy
Drug: Vasoactive drug therapies
Continue current vasoactive therapy
Other Names:
  • Diuretics
  • Nitrates
  • Antihypertensive
  • Alpha-antagonists
  • Neuroleptic antidepressant
  • L-dopa antagonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of syncope or presyncope and adverse events
Time Frame: From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years
Combined end-point of rate of patients with recurrence of (pre)syncope and adverse events
From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Syncope
Time Frame: From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years
Recurrence of syncope
From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years
Presyncope
Time Frame: From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years
Burden of presyncope, measured as number of episodes of presyncope/s per month assessed up to 2 years by mean of a patient's diary
From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute study
Time Frame: 1 month
Quality of life assessed by means of the Specific symptom Scale - Orthostatic Hypotension questionnaire. Results of carotid sinus massage and tilt table test
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 10, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 28, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASL4/CARD/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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