NCT03803215

Brief Summary

The study aims at assessing that theophylline is effective in patients with no prodromes, normal heart and with low values of plasmatic adenosine compared with a propensity-score matched untreated control population who have received an implantable cardiac monitor (ICM) for diagnosis of unexplained or atypical reflex syncope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

May 11, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2020

Enrollment Period

4.6 years

First QC Date

January 10, 2019

Last Update Submit

January 18, 2021

Conditions

Syncope

Keywords

theophyllineasystoleimplantable loop recorder

Outcome Measures

Primary Outcomes (1)

  • Asystolic syncope

    Number of patients. The primary objective aims to test the hypothesis that theophylline is able to reduce asystolic events in the Low-Adenosine subgroup compared with the propensity-score matched control group

    24 months

Secondary Outcomes (3)

  • Time to first syncope recurrence

    24 months

  • Asystolic syncope in the subgroup with low adenosine plasmatic values

    24 months

  • Asystolic syncope in patients without prodrome, normal heart and normal ECG

    24 months

Study Arms (2)

Theophylline group

Patients who have electrocardiographic documentation of asystolic syncope will be treated with oral theophylline at tailored dosage

Drug: Theophylline

Control untreated group

A propensity-score matched control group is generated from the large database of patients who had received an implantable loop recorder

Interventions

TheophyllineDRUG

Oral theophylline initially 600 mg bid and then titrated at the maximum tolerated dose

Theophylline group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have received an implantable cardiac monitor (ICM) for diagnosis of unexplained or atypical reflex syncope

You may qualify if:

  • Male or female gender with age \>18 years
  • Unexplained syncope without prodrome or neurally-mediated syncope with atypical prodrome, with normal heart and normal ECG
  • Two syncopes /last year or 3 syncopes /last 2 years before start of theophylline treatment
  • Having received an ICM according to conventional guideline-based indications
  • Being treated with oral theophylline therapy, while been waiting for ICM diagnosis
  • Having signed a written informed consent to the study participation and to the treatment of personal data

You may not qualify if:

  • Typical vaso-vagal syncope with long prodromes and situational syncope
  • Any other form of syncope/T-LOC different from reflex syncope
  • Pregnant or breast-feeding patients -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Ospedali del Tigullio

Lavagna, 16033, Italy

Location

Related Publications (1)

  • Brignole M, Iori M, Strano S, Tomaino M, Rivasi G, Ungar A, Carretta D, Solari D, Napoli P, Deharo JC, Guieu R. Theophylline in patients with syncope without prodrome, normal heart, and normal electrocardiogram: a propensity-score matched study verified by implantable cardiac monitor. Europace. 2022 Jul 21;24(7):1164-1170. doi: 10.1093/europace/euab300.

    PMID: 34849728DERIVED

MeSH Terms

Conditions

SyncopeHeart Arrest

Interventions

Theophylline

Condition Hierarchy (Ancestors)

UnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Michele Brignole, MD

    Department of Cardiology, Ospedali del Tigullio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 14, 2019

Study Start

May 11, 2016

Primary Completion

November 30, 2020

Study Completion

December 30, 2020

Last Updated

January 20, 2021

Record last verified: 2020-01

Locations

IT(1)