Evaluating the effects of SGLT2 inhibitors on heart failure biomarkers

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

This study is testing if a new type of diabetes medication can improve heart health and symptoms in people with heart failure over 26 weeks.

Quick facts

• Study type: Observational
• Enrollment: 68 (estimated)
• Ages: 40 Years to 90 Years
• Sex: All
• Sponsor: Queen's University, Belfast (Academic / other)
• Locations: 1 site (Belfast)
• Trial ID: NCT06140251 on ClinicalTrials.gov

What this trial studies

This observational study investigates the impact of sodium-glucose cotransporter 2 (SGLT2) inhibition on cardiac biomarkers and myocardial remodeling in patients with heart failure. Over a 26-week period, participants will receive SGLT2 inhibitors while their cardiac health is monitored through echocardiography and patient-reported outcomes. The study aims to explore novel cardiac pathways and assess changes in both standard and new biomarkers associated with heart failure. The findings may provide insights into the therapeutic mechanisms of SGLT2 inhibition in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 90 with heart failure and specific echocardiographic markers indicating impaired or preserved left ventricular function.

Not a fit: Patients currently receiving SGLT2 inhibitors or those with contraindications to this therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for heart failure patients by identifying effective biomarkers for monitoring therapy.

How similar studies have performed: Previous studies have shown promising results with SGLT2 inhibitors in heart failure, indicating potential for success in this exploratory approach.

Eligibility criteria

Inclusion Criteria:

1. Provision of signed informed consent prior to any study specific procedures.
2. Male or female, between 40 and 90 years of age.
3. 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).
4. New York Heart Association (NYHA) class II, III, or IV symptoms.
5. On optimal tolerated evidence-based HF medications.
6. Patients may be ambulatory or recently hospitalized; however, must be \>6 weeks post-discharge on stable diuretic therapy.

Exclusion Criteria:

1. Receiving therapy with an SGLT2 inhibitor \> 6 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor.
2. Severe (eGFR \<20 mL/min/1.73m2), unstable or rapidly progressing renal disease at the time of recruitment.
3. Type 1 diabetes mellitus
4. Recent hospitalisation \< 1 month.
5. Symptomatic hypotension or systolic BP \<95 mmHg at 2 out of 3 measurements
6. Symptomatic bradycardia or second or third-degree heart block without a pacemaker.
7. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after recruitment.
8. Cardiomyopathy secondary to uncorrected primary valvular disease, infiltrative, arrhythmogenic or right ventricular dysplasia.
9. Significant comorbidity including; pulmonary lung disease requiring home oxygen or non-invasive ventilation, CTEPH or primary pulmonary hypertension.

Where this trial is running

Belfast

• Belfast Health and Social Care Trust — Belfast, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Lana Dixon, MD — Belfast Health and Social Care Trust
• Study coordinator: Patrick Savage, MB BChBAO Bsc

Conditions Heart Failure; Heart failure; Cardiac imaging; SGLT2; Biomarkers