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Extend Release Exenatide Versus Placebo in Diabetic Patients With Type 4 Cardiorenal Syndrome

Research area:
Cardiorenal Syndrome
Principal investigator:
Peter A. McCullough, MD, MPH, FACC, FACP, FAHA, FCCP, FNKF, FNLA, FCRSA
Type of study:
Interventional

Study synopsis:
Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with impaired relaxation of the heart mildly reduced kidney filtration function (Type 4 cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of treatment with exenatide extended-release injections versus placebo on the outcome of an integrated cardiac biomarker blood test score, myocardial tissue characterization seen on magnetic resonance scanning, cardiac strain identified by ultrasonography and strain rate imaging, and an integration kidney urine biomarker score derived from multiple protein markers.

EXTEND-CRS is Baylor Scott & White’s largest investigator-initiated grant funding an original randomized trial in which patients are testing an established medication, exenatide for diabetes, and undergoing extensive cardiac testing, including advanced magnetic resonance imaging and strain rate echocardiography. The goal of this study is to understand how diabetes medications affect the heart in terms of is morphology and its protein expression. Baylor Scott & White is helping to identify potential unique measures of cardiac health that could tell doctors if the heart is improving or worsening over time through specific studies done within the EXTEND-CRS program. EXTEND-CRS has been funded by Astra Zeneca and a diabetes consortium over the past five years and will conclude in 2020,” says Peter McCullough, MD, principal investigator.

Study objective:
The primary aim of the study is to evaluate the quantitative impact on the MISS (myocardial injury summary score) cardiac biomarker score, cardiac fibrosis by MRI, cardiac strain by ultrasonography and strain rate imaging, and KISS (kidney injury summary score) kidney biomarker score after 38 weeks of treatment with exenatide extended-release or placebo. The study will evaluate this impact among adult individuals with type 2 diabetes mellitus (T2DM) and at risk for diastolic heart failure (DHF) and mildly reduced renal filtration function (Type 4 cardiorenal syndrome).

Main/critical inclusion and exclusion criteria: A complete list of inclusion and exclusion criteria can be found at https://www.clinicaltrials.gov/ct2/show/NCT02251431?cond=NCT02251431&rank=1

Study contact:
Jessica Propps, BS, ACRP-CP, Jessica.Propps@BSWHealth.org, 214.820.7762.

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