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Guideline-based Pacing Therapy for Reflex Syncope (SUP2)

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ClinicalTrials.gov Identifier: NCT01509534
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
Gruppo Italiano Multidisciplinare per lo Studio della Sincope

Brief Summary:
Study hypothesis: Dual-chamber pacemaker therapy with rate-hysteresis features is effective in preventing syncopal recurrences in patients affected by cardioinhibitory (CI) forms of reflex syncope diagnosed by means of carotid sinus massage, tilt table testing or implantable loop recorder (ILR). The outcome is measured either by the time to first syncopal recurrence or the total syncope burden.

Condition or disease

Detailed Description:

Background Divergence of opinion exists regarding the efficacy of cardiac pacing in patients affected by different forms of reflex syncope.


Severe syncope is defined when:

  • it is perceived by patient that it alters his/her quality of life, and
  • is unpredictable because occurs without, or with very short prodromes < 10 sec (thus exposing patients to risk of trauma) or, if preceded by prodromes, syncope recurs despite appropriate therapies (CPM or drugs).

Recurrent syncopes: at least 2 episodes during the last year (including the index episode) or 3 episodes during the last 2 years (including the index episode).

Suspected (undetermined) reflex syncope: the suspicion of reflex syncope is based on a history of uncertain syncope in the absence of (i) severe structural heart disease, significant ECG abnormalities, or rhythm disturbances; (ii) orthostatic hypotension; and (iii) non-syncopal causes of transient loss of consciousness.

Study protocol

  1. The eligible patients undergo firstly carotid sinus massage (according to the method of symptoms); if a diagnosis of cardioinhibitory carotid sinus syndrome (CI-CSS) is made, a pacemaker is implanted and follow-up immediately starts.
  2. If the carotid sinus massage is negative or vasodepressor, the patients undergo tilt table testing (with nitroglycerin or clomipramine drug challenge); if a diagnosis of VASIS 2B form is made, a pacemaker is implanted and follow-up immediately starts.
  3. If tilt table testing is negative or a form different from VASIS 2B is induced, the patients undergo ILR implantation. If a diagnosis of asystolic reflex syncope is made, a pacemaker is implanted and follow-up immediately starts.

End-points End-point of the study is syncope recurrence after pacemaker (PM) implantation. Syncope is defined as complete transient loss of consciousness. Pre-syncope is counted but it is not an end-point.

Primary end-points:

  1. Comparison of the time to first syncopal recurrence in CI-CSS and CI-TTT pts with PM and in control patients with ILR.
  2. Intra-patient comparison of the syncope burden in the year before and in the year following PM implant in all patients receiving a PM (CCS, TTT and ILR groups). Index syncope is not counted.

Follow-up One year after PM implantation for all enrolled patients for burden of syncope end-points Until the study end for time to first syncope recurrence end-points. Thus, the study ends one year after the enrollment of the last patient.

Study size Based on the sample size calculation the study will stop when 700 patients are enrolled.

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Study Type : Observational
Actual Enrollment : 281 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Guideline-based Pacing Therapy for Reflex Syncope
Study Start Date : January 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Primary Outcome Measures :
  1. syncope recurrence after PM implantation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. syncope burden after PM implantation [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients affected by reflex syncopes

Inclusion Criteria:

  • Patients affected by severe, recurrent, certain or suspected (undetermined) reflex syncopes, aged ≥ 40 years.

Exclusion Criteria:

  • Reflex syncopes due to reversible causes, e.g., vasoactive drugs, concomitant diseases, etc
  • Suspected of certain cardiac syncope
  • Syncope caused by orthostatic hypotension
  • Non-syncopal causes of transient loss of consciousness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509534

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Ospedale Generale Regionale
Bolzano, Italy
AO di Rilievo Nazionale e di Alta Specializzazione Garibaldi
Catania, Italy
PO S. Giuseppe
Empoli, Italy
AO Careggi
Firenze, Italy
Nuovo Ospedale S. Giovanni di Dio
Firenze, Italy
Department of Cardiology, Ospedali del Tigullio
Lavagna, Italy, 16033
Arcispedale S. Maria Nuova
Reggio Emilia, Italy
Ospedale SS. Annunziata
Taranto, Italy
Sponsors and Collaborators
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
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Principal Investigator: Michele Brignole, MD Ospedali del Tigullio, Lavagna, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gruppo Italiano Multidisciplinare per lo Studio della Sincope
ClinicalTrials.gov Identifier: NCT01509534    
Other Study ID Numbers: GIMSI-001-2011
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Keywords provided by Gruppo Italiano Multidisciplinare per lo Studio della Sincope:
implantable loop recorder
Additional relevant MeSH terms:
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Syncope, Vasovagal
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases