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Clinical Trial Details

Trial ID: L4703
Source ID: NCT02397421
Associated Drug: Dapagliflozin
Title: Safety and Effectiveness of SGLT-2 Inhibitors in Patients With Heart Failure and Diabetes
Acronym: REFORM
Status: COMPLETED
Study Results: NO
Results:
Conditions: Heart Failure|Diabetes
Interventions: DRUG: Dapagliflozin|DRUG: Placebo
Outcome Measures: Primary: Change in LV end systolic volume (absolute value and indexed for BSA) or LV end diastolic volume (absolute value and indexed for BSA), Cardiac MRI will be performed to determine the change in end systolic and diastolic volumes between both groups of patients, 1 year | Secondary: Change in LV mass, LV ejection fraction, RV end diastolic volume, RV end systolic volume, RV ejection fraction, atrial dimensions and volumes, and LV remodelling index (LV mass / LVEDV), MRI will be performed to study the effects of the intervention on various other cardiac parameters., 1 year|Fluid status (Bioelectrical Impedence Analysis (BIA), Bioelectrical Impedence Analysis (BIA) will be conducted to determine the effect of the study dug on overall fluid balance, 1 year|Objective functional capacity (6 Minute Walk Test (6MWT), 6 Minute Walk Test (6MWT) will be performed to objectively determine the functional capacity of participants, 1 year|Exercise capacity (Cardio-pulmonary Exercise Testing (CPET), Cardio-pulmonary Exercise Testing (CPET) will be performed to determine the exercise capacity of participants, 1 year|Quality of life (Minnesota Living with Heart Failure and SF-36 questionnaire), will be conducted to determine the impact of the intervention on subjective quality of life, 1 year|Cardiac and inflammatory biomarkers, Brain natriuretic peptide (BNP) and other inflammatory \& oxidative stress markers will be measured, 1 year|Diuretic requirement (total diuretic requirement to maintain euvolemia), The total diuretic requirement to maintain euvolemia will be compared between the beginning and end of the trial, 1 year|Change in degree of microalbuminuria, Urinary analysis will be performed to determine if there has been any change in the severity of microalbuminuria, 1 year|Quantify amount of natriuresis, Urinary analysis will be performed to quantify the amount of sodium excretion., 1 year|The safety of dapagliflozin use in diabetic, heart failure patients with regard to worsening HF, hospitalization and death will be evaluated, 1 year
Sponsor/Collaborators: Sponsor: University of Dundee | Collaborators: European Foundation for the Study of Diabetes
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 56
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-03
Completion Date: 2017-08
Results First Posted:
Last Update Posted: 2018-07-31
Locations: Ninewells Hospital and Medical School, Dundee, Angus, DD1 9SY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02397421