NCT02861274

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

5 years

First QC Date

August 1, 2016

Last Update Submit

August 5, 2016

Conditions

Syncope Recurrent

Outcome Measures

Primary Outcomes (1)

  • syncope recurrence

    360 days

Study Arms (2)

electrophysiological testing

ACTIVE COMPARATOR

Patients will receive a pacemaker.

Device: pacemaker

control group

NO INTERVENTION

These subjects will receive cardicor® (beta blockers).

Interventions

pacemakerDEVICE
electrophysiological testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • age inferior 18 years, history of myocardial infarction, heart failure, structural heart disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30075596DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc, PHD

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 10, 2016

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

September 1, 2015

Last Updated

August 10, 2016

Record last verified: 2016-08