Status:
UNKNOWN
Investigation of Biomarker Response to SGLT2 Inhibition in Heart Failure
Lead Sponsor:
Queen's University, Belfast
Collaborating Sponsors:
Belfast Health and Social Care Trust
Conditions:
Heart Failure
Eligibility:
All Genders
40-90 years
Brief 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 o...
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 p...
Eligibility Criteria
Inclusion
- Provision of signed informed consent prior to any study specific procedures.
- Male or female, between 40 and 90 years of age.
- LVEF \<50% on echocardiography or if \>50%, co-existing structural markers of diastolic dysfunction must be present;
- LA width (diameter) ≥3.8 cm or LA length ≥5.0 cm, or LA area ≥20 cm, or LA volume ≥55 mL or LA volume index ≥29 mL/m.
- Left ventricular hypertrophy.
- Markers of diastolic dysfunction as assessed by pulsed wave doppler echocardiography.
- N-terminal pro-B-type natriuretic peptide (NT-proBNP) of at least 125pg per millilitre (or ≥365pg per millilitre if co-existing atrial fibrillation).
- New York Heart Association (NYHA) class II, III, or IV symptoms.
- On optimal tolerated evidence-based HF medications.
- Patients may be ambulatory or recently hospitalized; however, must be \>6 weeks post-discharge on stable diuretic therapy.
Exclusion
- Receiving therapy with an SGLT2 inhibitor \> 6 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor.
- Severe (eGFR \<20 mL/min/1.73m2), unstable or rapidly progressing renal disease at the time of recruitment.
- Type 1 diabetes mellitus
- Recent hospitalisation \< 1 month.
- Symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements
- Symptomatic bradycardia or second or third-degree heart block without a pacemaker.
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after recruitment.
- Cardiomyopathy secondary to uncorrected primary valvular disease, infiltrative, arrhythmogenic or right ventricular dysplasia.
- Significant comorbidity including; pulmonary lung disease requiring home oxygen or non-invasive ventilation, CTEPH or primary pulmonary hypertension.
Key Trial Info
Start Date :
August 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT06140251
Start Date
August 21 2023
End Date
May 1 2025
Last Update
November 18 2023
Active Locations (1)
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1
Belfast Health and Social Care Trust
Belfast, United Kingdom