Heart Failure Clinical Trial
— SCARFOfficial title:
SCARF: Saxagliptin on CArdiac StRucture and Function
NCT number | NCT02481479 |
Other study ID # | 14-267 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | August 2018 |
Verified date | March 2019 |
Source | St. Michael's Hospital, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 18 |
Est. completion date | August 2018 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult (=18 years old) men or women with type 2 diabetes diagnosed for = 6 months 2. HbA1c 7.5 - 9.5% 3. Receiving background therapy with metformin (additional anti-hyperglycemic agents are permitted) 4. Clinical decision to initiate saxagliptin to improve glycemic control, as per treating physician Exclusion Criteria: 1. GLP-1 receptor agonist or DPP4 inhibitor treatment within the past 6 months, or known intolerance 2. eGFR <30 3. Baseline LVEF <40% 4. NYHA Class III-IV or recent hospitalization for decompensated HF (<3 months) 5. Unstable coronary syndromes or recent revascularization within the past 3 months, or planned revascularization in the next 6 months 6. Significant (moderate or severe, or symptomatic) valvular disease 7. Pregnancy/childbearing potential 8. Routine contraindications to CMR Subjects who drop out from the study will have a repeat CMR examination as soon as possible after drug discontinuation. |
Country | Name | City | State |
---|---|---|---|
Canada | St Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
St. Michael's Hospital, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in LVEF from baseline to 6 months | assess LVEF at baseline and at 6 months following treatment. CMR based LVEF assessment using Cvi 42. | baseline, 6 months | |
Secondary | The change in E/e' from baseline to 6 months | Echocardiography assessed E and E', to determine ratio, and assess change from baseline to 6 months. | baseline, 6 months | |
Secondary | change in class indicators of signs and symptoms of heart failure at each visit | assess NYHA class at baseline and at 6 months | baseline, 6 months | |
Secondary | Change in log-scale in NT-pro BNP | assess NT-ProBNP at baseline and at 6 months | baseline, 6 months |
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