Exercise effects of Dapagliflozin in type II diabetes and heart failure

Phase 3

• Conditions: Heart Failure; Cardiovascular - Other cardiovascular diseases; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618001981213
• Lead Sponsor: Flinders Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-10
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

•Patients with previously diagnosed T2DM for which they are on prescribed glucose lowering therapy.
•Admission with an episode of decompensated heart failure.
•Heart failure with reduced ejection fraction (HFrEF) (documented EF <=40%)
•Qualify for add on SGLT2 inhibitor glucose lowering therapy for DM according to current guidelines
•Patients who are being prescribed an add-on SGLT2 inhibitor (long term) by the responsible hospital medical team on the basis of their medical judgment (independent of the trial) for the approved PBS indication of suboptimal glycaemic control.
•On guideline-recommended therapy for their heart failure (or documented reason why not)
•Clinically stable at the time of recruitment
•Live within a geographically accessible area for follow-up

Exclusion Criteria

•Age less than 18 years
•Unable to provide written informed consent to participate in the study (this includes the inability to communicate fluently with the investigator and cognitive incompetence)
•Valvular stenosis of > moderate severity
•Valvular regurgitation >=severe and planning corrective invasive therapy
•Oncologic (or other) life expectancy <12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not medically appropriate for the patient to participate in this trial
•eGFR <60 ml/min/1.73m2
•Past history of ketoacidosis
•Past history of frequent or significant genital candidiasis
•Already taking or past intolerance to an SGLT2 inhibitor
•Pregnant, breastfeeding or women of child bearing potential without adequate contraception
•Elective surgery in the next 8 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in 6-minute walk test [The patient will be consented at time 0, At 2 weeks they will have all assessments (baseline) and commence randomised drug or placebo. At 4 weeks they will again have all assessments and stop trial drug. They will then have a 2 week washout period and then crossover to drug or placebo for 2 weeks. they will then have their 3rd and final assessment (week 8). <br>To be clear baseline assessment is at 2 weeks, assessments are done again on all patients at week 4 and week 8 (each of which is after 2 weeks of drug or placebo treatment).]