Electrophysiological Mechanisms and Inhibitory Cardiac Syncope

NCT ID: NCT02861274

Last Updated: 2016-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-09-30

Brief Summary

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OBJECTIVES: To evaluate syncope recurrence at follow up in patients with a positive cardio inhibitory response to the head up tilt testing (HUT) evaluation.

METHODS: 36 consecutive patients affected by cardio inhibitory syncope to HUT without asystolia (2A type) have been enrolled in this study. These patients have been studied by electrophysiological study (ES). After ES patients have been differently treated (interventional treatment group A, v/s drug therapy group), and followed up during 360 days, to evaluate syncope recurrences.

Detailed Description

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Conditions

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Syncope Recurrent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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electrophysiological testing

Patients will receive a pacemaker.

Group Type ACTIVE_COMPARATOR

pacemaker

Intervention Type DEVICE

control group

These subjects will receive cardicor® (beta blockers).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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pacemaker

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age more than 18, normal heart function, more than 1 syncope event for year.

Exclusion Criteria

* age inferior 18 years, history of myocardial infarction, heart failure, structural heart disease.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Celestino Sardu

MD, MSc, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Sardu C, Marfella R, Testa G, Santamaria M, Sacra C, Ranauro A, Paolisso G, Rizzo MR, Barbieri M. ELectrophysiological mechanisms underlying the Inhibitory CArdiac syncope without asystolic significant pause: Therapeutic and prognostic implications. The ELICA randomized trial. Medicine (Baltimore). 2018 Aug;97(31):e11757. doi: 10.1097/MD.0000000000011757.

Reference Type DERIVED
PMID: 30075596 (View on PubMed)

Other Identifiers

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7.2016

Identifier Type: -

Identifier Source: org_study_id

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