Chewing gum to relieve thirst in chronic heart failure

• Conditions: Chronic heart failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12614000943640
• Lead Sponsor: niversity of Technology, Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

1.Aged >18 years old
2.Heart failure as either primary or secondary diagnosis (as per NHFA and ESC guidelines)
Definition:
CHF: Is a complex syndrome characterised by underlying cardiac dysfunction (either associated with impaired or preserved systolic function) and typical symptoms of exercise intolerance.
CHF with diastolic dysfunction: CHF with normal or near normal left ventricular (LV) ejection fraction (EF), normal or near normal LV volume, and evidence of diastolic dysfunction (e.g. abnormal pattern of LV filling and elevated filling pressures)[R][R].
3.On oral loop diuretics
4.Able to safely chew and swallow
5.Able to provide informed consent
6.Able to read, speak and understand English

Exclusion Criteria

1.On intravenous inotropes. Patients will be eligible once they have been weaned off the intravenous inotrope.
2.Unable to provide informed consent
3.People using chewing gum regularly
4.Restricted chewing and/or swallowing (i.e. due to dysphagia or other impairment)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the level of perceived thirst in the short term (average of 24 hours each day for 4 days). This outcome will be assessed using a 100mm visual analogue scale and a numeric rating scale (0-10). [Daily for days 1-4 of treatment (chewing gum)/control period]

Secondary Outcome Measures

Name	Time	Method
Change in the level of perceived thirst in the longer term (7 days, 2 weeks and 4 weeks). This outcome will be assessed using a 100mm visual analogue scale and a numeric rating scale (0-10). <br>[At days 7, 14 and 28];Improvements in health related quality of life (HRQoL). This outcome will be assessed using the Kansas City Cardiomyopathy Questionnaire. <br><br>[At 4 weeks after randomisation];Effect of chewing gum on weight stability over the study period. This will be assessed using weight measurements provided by the participants. [Daily for days 1-4, at day 7, 14 and 28 of treatment/control period];Views and perception of CHF patients on the use of chewing gum. Participants will be asked what their views and perception of the use of chewing gum over the phone. [At 4 weeks after randomisation ]