Hypotensive SyncopePhase 3STOP-VDNCT02137278

Stop Vasodepressor Drugs in Reflex Syncope

A Phase 3 study testing Vasoactive drug therapies and Stop/reduce vasoactive drugs in people with Hypotensive Syncope, run by Gruppo Italiano Multidisciplinare per lo Studio della Sincope at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypotensive Syncope
What is being tested?: Vasoactive drug therapies and Stop/reduce vasoactive drugs
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteItaly
Study dates: Mar 2014to Dec 2015
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

Dipartimento di Cardiologia, Ospedali del Tigullio
Lavagna, 16032

Other trials in Italy

About this study

Official title: 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.

Read the 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

Conditions: Hypotensive Syncope
Being tested: Vasoactive drug therapies, Stop/reduce vasoactive drugs
Keywords: Syncope, Presyncope, Vasoactive drugs, Hypotension, Carotid sinus massage, Tilt table test
Medical subject headings: Syncope, Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vasoactive drug therapiesDrug
Also called Antihypertensive, Nitrates, Alpha-antagonists, Diuretics
Continue current vasoactive therapy
Stop/reduce vasoactive drugsOther
Also called Antihypertensive, Nitrates, Alpha-antagonists, Diuretics
Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.

Study groups in NCT02137278
Study group	Role	What they receive
Stop/reduce vasoactive drugs	Active comparator	Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment Receives: Other: Stop/reduce vasoactive drugs
Vasoactive drug therapy	Experimental	Continue current vasoactive therapy Receives: Drug: Vasoactive drug therapies

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

Syncope
Recurrence of syncope
Measured: From date of randomization until the date of first documented syncope or adverse event, whichever come first, assessed up to 2 years
Presyncope
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
Measured: From date of randomization until the date of first documented syncope or adverse event, whichever came first, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Dec 2015

First posted13 May 2014 (estimated)
Study startMar 2014
Primary completionDec 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Hypotensive SyncopeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02137278
Sponsor's protocol ID: ASL4/CARD/01
Acronym: STOP-VD
Status last verified: Dec 2015
First submitted: 1 May 2014
Last updated: 29 Dec 2015
Results posted: No
Data monitoring committee: No

Publications

Gaggioli G, Brignole M, Menozzi C, Devoto G, Oddone D, Gianfranchi L, Gostoli E, Bottoni N, Lolli G. A positive response to head-up tilt testing predicts syncopal recurrence in carotid sinus syndrome patients with permanent pacemakers. Am J Cardiol. 1995 Oct 1;76(10):720-2. doi: 10.1016/s0002-9149(99)80207-0. No abstract available.
PubMed 7572635
Solari D, Maggi R, Oddone D, Solano A, Croci F, Donateo P, Brignole M. Clinical context and outcome of carotid sinus syndrome diagnosed by means of the 'method of symptoms'. Europace. 2014 Jun;16(6):928-34. doi: 10.1093/europace/eut283. Epub 2013 Sep 20.
PubMed 24058183
Podoleanu C, Maggi R, Brignole M, Croci F, Incze A, Solano A, Puggioni E, Carasca E. Lower limb and abdominal compression bandages prevent progressive orthostatic hypotension in elderly persons: a randomized single-blind controlled study. J Am Coll Cardiol. 2006 Oct 3;48(7):1425-32. doi: 10.1016/j.jacc.2006.06.052. Epub 2006 Sep 14.
PubMed 17010806
Brignole M, Menozzi C, Gaggioli G, Musso G, Foglia-Manzillo G, Mascioli G, Fradella G, Bottoni N, Mureddu R. Effects of long-term vasodilator therapy in patients with carotid sinus hypersensitivity. Am Heart J. 1998 Aug;136(2):264-8. doi: 10.1053/hj.1998.v136.89911.
PubMed 9704688

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial on Discontinuation of Vasoactive Drugs in Patients With Hypotensive Reflex Syncope
ClinicalTrials.gov ID: NCT02137278
Acronym / sponsor ID: STOP-VD / ASL4/CARD/01
Conditions: Hypotensive Syncope
Keywords: Syncope, Presyncope, Vasoactive drugs, Hypotension, Carotid sinus massage, Tilt table test
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Gruppo Italiano Multidisciplinare per lo Studio della SincopeUniversity, hospital or other
Study start: Mar 2014
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 13 May 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Stop/reduce vasoactive drugs	Active comparator	Other: Stop/reduce vasoactive drugsDiscontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment
Vasoactive drug therapy	Experimental	Drug: Vasoactive drug therapiesContinue current vasoactive therapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

Orthostatic hypotension defined as fall in systolic blood pressure >20 mmHg during the first 3 minutes of active standing
Competing diagnosis of syncope different from hypotensive reflex syncope
Reflex syncope with negative response to carotid sinus massage and tilt table test
Cardioinhibitory reflex syncope which requires permanent cardiac pacing
Severe hypertension which requires treatment (>150/95)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vasoactive drug therapiesAlso: Antihypertensive, Nitrates, Alpha-antagonists, DiureticsContinue current vasoactive therapy	Drug	Vasoactive drug therapy
Stop/reduce vasoactive drugsAlso: Antihypertensive, Nitrates, Alpha-antagonists, DiureticsDiscontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.	Other	Stop/reduce vasoactive drugs

Primary outcome

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

2 secondary outcomes

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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
Background: PubMed 7572635Gaggioli G, Brignole M, Menozzi C, Devoto G, Oddone D, Gianfranchi L, Gostoli E, Bottoni N, Lolli G. A positive response to head-up tilt testing predicts syncopal recurrence in carotid sinus syndrome patients with permanent pacemakers. Am J Cardiol. 1995 Oct 1;76(10):720-2. doi: 10.1016/s0002-9149(99)80207-0. No abstract available.
Results publication: PubMed 24058183Solari D, Maggi R, Oddone D, Solano A, Croci F, Donateo P, Brignole M. Clinical context and outcome of carotid sinus syndrome diagnosed by means of the 'method of symptoms'. Europace. 2014 Jun;16(6):928-34. doi: 10.1093/europace/eut283. Epub 2013 Sep 20.
Results publication: PubMed 17010806Podoleanu C, Maggi R, Brignole M, Croci F, Incze A, Solano A, Puggioni E, Carasca E. Lower limb and abdominal compression bandages prevent progressive orthostatic hypotension in elderly persons: a randomized single-blind controlled study. J Am Coll Cardiol. 2006 Oct 3;48(7):1425-32. doi: 10.1016/j.jacc.2006.06.052. Epub 2006 Sep 14.
Results publication: PubMed 9704688Brignole M, Menozzi C, Gaggioli G, Musso G, Foglia-Manzillo G, Mascioli G, Fradella G, Bottoni N, Mureddu R. Effects of long-term vasodilator therapy in patients with carotid sinus hypersensitivity. Am Heart J. 1998 Aug;136(2):264-8. doi: 10.1053/hj.1998.v136.89911.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02137278, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.