Clinical trial
Investigation of Biomarker Response to SGLT2 Inhibition Across Various Phenotypes of Heart Failure
Name
22063CW-UC
Description
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.
Trial arms
Trial start
2023-08-21
Estimated PCD
2024-09-01
Trial end
2025-05-01
Status
Recruiting
Treatment
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.
Other names:
SGLT2 inhibitors
Size
68
Primary endpoint
To evaluate whether SGLT2 inhibition in heart failure produces changes in novel cardiac biomarkers.
26 weeks
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva samples will be collected at both time points using a commercially available kit (SalivaBio Oral Swab Device, Salimetrics LLC, Carlsbad, CA, USA). Blood samples for novel biomarkers will be undergo centrifugation at 2500 g for 10 min with subsequent aliquoting and storage of plasma at -80 ∘C until required. Enzyme-linked immunosorbent assay (ELISA) based assays will be used to quantify levels of novel proteins as detailed below.'}, 'enrollmentInfo': {'count': 68, 'type': 'ESTIMATED'}}
Updated at
2023-11-18
1 organization
1 product
1 indication
Organization
Queen's University, BelfastIndication
Congestive Heart Failure