NCT06140251

Investigation of Biomarker Response to SGLT2 Inhibition in Heart Failure

Investigation of Biomarker Response to SGLT2 Inhibition Across Various Phenotypes of Heart Failure

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 68 (estimated)
• Sponsor: Queen's University, Belfast · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: —

Summary

This is a 26-week, open label, single-arm prospective evaluation of the effects of sodium glucose cotransporter 2 (SGLT2) inhibition on cardiac biomarkers, myocardial remodeling and patient reported outcomes in heart failure with both impaired and preserved left ventricular fraction.

Detailed description

The primary aims of this study are to evaluate whether SGLT2 inhibition in patients with heart failure effects changes in novel cardiac biomarkers. This is an exploratory evaluation of novel cardiac pathways which may serve to establish, as of yet unknown, therapeutic mechanisms of action of SGLT2 inhibition in heart failure. Secondary aims include evaluation of changes in standard of care biomarkers following SGLT2 inhibition and changes in markers of cardiac remodeling as identified on echocardiography. Further exploratory analysis will seek to correlate changes in quantitative and qualitative heart failure outcomes with changes in both novel and standard of care cardiac biomarkers.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DRUG	Sodium-glucose cotransporter 2 inhibitor	Patients identified with heart failure (both reduced ejection fraction and preserved) who are on optimal standard therapy and are candidates for treatment with SGLT2 inhibition will be identified from local heart failure databases, and local heart failure clinics. Following signed, informed consent and screening, patients will be allocated a first appointment where baseline clinical assessment and biomarker analysis will be obtained along with commencement on a SGLT2 inhibitor. Repeat assessment will be performed following a minimum period of 26 weeks.

Timeline

• Start date: 2023-08-21
• Primary completion: 2024-09-01
• Completion: 2025-05-01
• First posted: 2023-11-18
• Last updated: 2023-11-18

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study