MedTrace Logo

Saxagliptin and Cardiac Structure and Function

NCT02481479 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-03-30

No results posted yet for this study

Summary

Diabetes is associated with a substantially increased risk of heart failure, which is associated with substantial morbidity and mortality. Despite the development of new therapeutic strategies to improve glycemic control, recent clinical data from the saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus-thrombolysis in myocardial infarction (SAVOR-TIMI) 53 study observed an unexpected finding of an excess of adjudicated heart failure hospitalizations. This excess occurred in the setting of pre-existing heart failure (HF) hospitalization and in those with elevated biomarkers for heart failure such as N terminal pro Brain type natriuretic peptide (NT-pro BNP). A wealth of preclinical data did not suggest a mechanistic basis for an excess of heart failure events, however these preclinical studies primarily focused upon prevention based strategies as opposed to regression studies once established heart failure was present. This proposal seeks to understand if and how dipeptidyl peptidase-4 inhibitors (DPP4i,specifically saxagliptin) may influence the development of heart failure, by evaluating changes in cardiac structure and function using cardiac magnetic resonance imaging (MRI).

Conditions

Interventions

DRUG

Saxagliptin

Eligible patients will undergo baseline CMR, commence treatment and then after 6 months undergo repeat CMR

DRUG

Saxagliptin

Eligible patients will undergo baseline echocardiogram, commence treatment and then after 6 months undergo repeat echocardiogram

DRUG

saxagliptin

Eligible patients will undergo baseline venipuncture, commence treatment and then after 6 months undergo repeat venipuncture

Sponsors & Collaborators

  • Unity Health Toronto

    lead OTHER

Principal Investigators

  • Subodh Verma, MD · Professor of Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02481479 on ClinicalTrials.gov