April 3, 2020Diabetes CareOpen Access

Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial

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Why the study?

The study was designed to determine the effects of dapagliflozin on left ventricular remodeling using cardiac MRI in patients with heart failure and type 2 diabetes mellitus.

Does dapagliflozin 10 mg daily improve left ventricular remodeling in patients with type 2 diabetes mellitus and heart failure?

Population

56 patients with T2DM and HF with LV systolic dysfunction

Comparison

Dapagliflozin 10 mg daily vs placebo on top of usual therapy

Design

Randomized trial

Follow-up

1 year

Authors

JSJagdeep SinghNHS Fife IMIfy MordiHeart Failure / Cardiomyopathy KVKeeran VicknesonGuy's and St Thomas' NHS Foundation Trust

Discussion

Member takes

Implication

Do not expect reverse remodeling in mild HF plus T2DM; challenges remodeling as the driver of dapagliflozin’s proven outcome benefits.

Structured PICO

Does dapagliflozin 10 mg daily improve left ventricular remodeling in patients with type 2 diabetes mellitus and heart failure?

Population

56 patients with type 2 diabetes mellitus (T2DM) and symptomatic heart failure (HF) with previously documented reduction in left ventricular ejection fraction (LVEF). Mean age 67.1 years, 66.1% male. Key inclusion: stable therapy for at least 3 months, maximum loop diuretic dose of 80 mg/day, baseline eGFR ≥ 45 mls/min/1.73m2.

Intervention

Dapagliflozin 10 mg daily for 1 year, on top of usual therapy.

Comparator

Matching placebo for 1 year, on top of usual therapy.

Outcome

Change in left ventricular end-systolic volume (LVESV) using cardiac magnetic resonance (CMR) imaging at 1 year.surrogate

In patients with mild heart failure and type 2 diabetes, 1 year of dapagliflozin therapy did not significantly reverse left ventricular remodeling on CMR, suggesting its clinical benefits may be driven by other mechanisms such as diuresis.

Limitations

Mild severity of HF
Small sample size
Adjustment of loop diuretic dose may have affected ventricular volume/loading

Cite This Study

Singh et al. (2020) studied this question.

synapsesocial.com/papers/6a7f5aff9cb08e5f0c2ff637 https://doi.org/10.2337/dc19-2187

Topics

HFrEF treatment Heart failure SGLT2 inhibitors in heart failure

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Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial

Discussion

Member takes

Implication

Structured PICO

Limitations

Cite This Study

Topics

Dapagliflozin Versus Placebo on Left Ventricular Remodeling in Patients With Diabetes and Heart Failure: The REFORM Trial

Discussion

Member takes

Implication

Structured PICO

Limitations

Cite This Study

Also Consider

Topics

Also Consider