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SyncopeSUP2NCT01509534

Guideline-based Pacing Therapy for Reflex Syncope

An observational study of Syncope, run by Gruppo Italiano Multidisciplinare per lo Studio della Sincope at 8 sites 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

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). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Syncope
How many people
281 participants
Where
8 sitesItaly
Study dates
Jan 2012to Jul 2015
Phase
Observational
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients affected by reflex syncopes

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • Ospedale Generale Regionale

    Bolzano

  • AO di Rilievo Nazionale e di Alta Specializzazione Garibaldi

    Catania

  • PO S. Giuseppe

    Empoli

  • AO Careggi

    Florence

  • Nuovo Ospedale S. Giovanni di Dio

    Florence

  • Department of Cardiology, Ospedali del Tigullio

    Lavagna, 16033

  • Arcispedale S. Maria Nuova

    Reggio Emilia

  • Ospedale SS. Annunziata

    Taranto

Other trials in Italy

About this study

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.

Read the detailed description

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

Definitions.

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.

Conditions
Syncope
Keywords
pacemaker, implantable loop recorder, syncope
Medical subject headings
Syncope

What is being measured

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

  1. syncope recurrence after PM implantation

    Measured: 1 year

Secondary outcomes (1)

  1. syncope burden after PM implantation

    Measured: 1 year

Timeline

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

  1. First posted13 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
281 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01509534
Sponsor's protocol ID
GIMSI-001-2011
Acronym
SUP2
Status last verified
Jul 2015
First submitted
5 Dec 2011
Last updated
29 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Solari D, Tesi F, Unterhuber M, Gaggioli G, Ungar A, Tomaino M, Brignole M. Stop vasodepressor drugs in reflex syncope: a randomised controlled trial. Heart. 2017 Mar;103(6):449-455. doi: 10.1136/heartjnl-2016-309865. Epub 2016 Sep 23.

    PubMed 27664002

  • Brignole M, Arabia F, Ammirati F, Tomaino M, Quartieri F, Rafanelli M, Del Rosso A, Rita Vecchi M, Russo V, Gaggioli G; Syncope Unit Project 2 (SUP 2) investigators. Standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncope: 3-year insights from the Syncope Unit Project 2 (SUP 2) study. Europace. 2016 Sep;18(9):1427-33. doi: 10.1093/europace/euv343. Epub 2015 Nov 26.

    PubMed 26612880

  • Brignole M, Ammirati F, Arabia F, Quartieri F, Tomaino M, Ungar A, Lunati M, Russo V, Del Rosso A, Gaggioli G; Syncope Unit Project (SUP) Two Investigators. Assessment of a standardized algorithm for cardiac pacing in older patients affected by severe unpredictable reflex syncopes. Eur Heart J. 2015 Jun 21;36(24):1529-35. doi: 10.1093/eurheartj/ehv069. Epub 2015 Mar 29.

    PubMed 25825044

Questions about this trial

What is this clinical trial studying?

An observational study of Syncope, run by Gruppo Italiano Multidisciplinare per lo Studio della Sincope at 8 sites in Italy.

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 4 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 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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.

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?

syncope recurrence after PM implantation (time frame: 1 year). 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 NCT01509534, which also lists 3 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 Jul 2015.

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