Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 55 of 1197 for:    Adenosine

Theophylline for Low Adenosine Syncope (THEO-USA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803215
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborator:
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Information provided by (Responsible Party):
Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella

Tracking Information
First Submitted Date January 10, 2019
First Posted Date January 14, 2019
Last Update Posted Date January 14, 2019
Actual Study Start Date May 11, 2016
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2019)
Asystolic syncope [ Time Frame: 24 months ]
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 11, 2019)
  • Time to first syncope recurrence [ Time Frame: 24 months ]
    Months from enrolment to the first recurrence of syncope
  • Asystolic syncope in the subgroup with low adenosine plasmatic values [ Time Frame: 24 months ]
    Number of patients with asystolic syncope during follow-up
  • Asystolic syncope in patients without prodrome, normal heart and normal ECG [ Time Frame: 24 months ]
    Number of patients with asystolic syncope during follow-up
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Theophylline for Low Adenosine Syncope
Official Title Theophylline in Patients With Unexplained Syncope and Low Adenosine. Study Verified by ICM, Controlled by Propensity-score Matching
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.
Detailed Description

Theophylline has been used for 3 decades in ordinary medical practice to tentatively prevent syncopal recurrences in patients affected by neurally-mediated syncope. Observational studies report a recurrence rate with this drug ranging between 12% and 22%. Theophylline was much more effective in selected patients with syncope without prodromes and normal heart who had ECG documentation of long pauses at the time of syncopal attack and low values of baseline plasmatic adenosine. Since theophylline is a non-selective antagonist of purinergic receptors, it has been hypothesized that purinergic receptors are involved in the mechanism of syncope in such patients. Conversely, theophylline was suspected to be ineffective (or less effective) in patients affected by other forms of neurally-mediated syncope.

The present 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.

This will be a multicenter, non interventional study, verified by ICM, with 2 predefined subgroups:

Subgroup #1

  • Low adenosine group: Patients with Low Adenosine values (<0.40 μmol/L)
  • Normal/high adenosine (≥0.40 μmol/L) group: any other patient Subgroup #2
  • Patients with no prodromes or very short prodromes (≤5 sec), normal heart and normal ECG (No prodrome group)
  • Any other form of atypical neurally-mediated syncope with prodromes >5 sec. Remote or in-hospital periodic follow-up will be done according to centre's clinical practice for ICM monitoring.

Patients will be followed up until the first primary endpoint event with a maximum follow-up of 24 months since start of theophylline treatment.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who have received an implantable cardiac monitor (ICM) for diagnosis of unexplained or atypical reflex syncope
Condition Syncope
Intervention Drug: Theophylline
Oral theophylline initially 600 mg bid and then titrated at the maximum tolerated dose
Study Groups/Cohorts
  • Theophylline group
    Patients who have electrocardiographic documentation of asystolic syncope will be treated with oral theophylline at tailored dosage
    Intervention: 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 11, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Typical vaso-vagal syncope with long prodromes and situational syncope
  2. Any other form of syncope/T-LOC different from reflex syncope
  3. Pregnant or breast-feeding patients -
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Michele Brignole, MD +390185329567 mbrignole@ASL4.liguria.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03803215
Other Study ID Numbers CPM 30102018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
Study Sponsor Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
Collaborators Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Investigators
Principal Investigator: Michele Brignole, MD Department of Cardiology, Ospedali del Tigullio
PRS Account Centro Prevenzione Malattie Cardiovascolari N. e V. Corbella
Verification Date January 2019