The Effect of Beta-blockers in Substance P Levels and the Swallowing Function
BETASP
1 other identifier
observational
60
1 country
1
Brief Summary
A non-randomised, prospective study to assess the effects of beta-blockers on substance P levels and the swallowing function. The study is going to be carry out in the Gastrointestinal Physiology Laboratory of the Hospital de Mataró (Spain). All participants will be actively recruited from a Linked hospital and primary care database. We include two groups: the first group (group 1) are participants taking beta-blockers and the second group (group 2) are participants not-taking beta-blockers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2017
CompletedFirst Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
October 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFebruary 22, 2018
February 1, 2018
1.5 years
September 22, 2017
February 21, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Substance P levels
In blood and saliva
1 year
Study Arms (2)
BETA-BLOCKERS
Patients taking beta-blockers with or without dysphagia
NO BETA-BLOCKERS
Patients not taking beta-blockers with or without dysphagia
Interventions
An overall assessment is going to be carry out by a multidisciplinary team during the visit. Swallowing assessment is going to be performed during the visit. We are going to use: (i) the Eating Assessment Tool (EAT-10), which is a short 10-item, easy to use, self-administered questionnaire \[4\]. Although the EAT-10 is considered to be predominantly a questionnaire on FHS, some items on HR-QoL are also included. The sum score of this 10-item questionnaire ranges from 0 to 40, and (ii) the Sydney Swallowing Questionnaire (SSQ) to clinically assess the severity of the symptoms of dysphagia, if present. All subjects are going to be submitted to the volume-viscosity swallow test (V- VST)
Eligibility Criteria
All population.
You may qualify if:
- \- Patients taking and not taking beta-blockers
You may not qualify if:
- Participants with heat and neck or esophageal cancer
- Participants with stroke or neurological disease
- Participants with central nervous system disease
- Participants with concomitant treatment with Angiotensin converting enzyme inhibitors (ACEI), Angiotensin II receptor antagonists (ARA-II), Antipsychotics, Dopamine agonists, Capsaicine.
- Participants with severe clinical signs of aspiration, including oxygen desaturation ≥3%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mataró Hospital
Mataró, Barcelona, 08304, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marta Miarons
Mataró Hospital
Central Study Contacts
Laia Rofes
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical pharmacist
Study Record Dates
First Submitted
September 22, 2017
First Posted
October 10, 2017
Study Start
June 5, 2017
Primary Completion
November 25, 2018
Study Completion
December 31, 2018
Last Updated
February 22, 2018
Record last verified: 2018-02