Heart Failure Clinical Trial
— SiN-HFOfficial title:
Investigation of Biomarker Response to SGLT2 Inhibition Across Various Phenotypes of Heart Failure
NCT number | NCT06140251 |
Other study ID # | 22063CW-UC |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 21, 2023 |
Est. completion date | May 1, 2025 |
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.
Status | Recruiting |
Enrollment | 68 |
Est. completion date | May 1, 2025 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Belfast Health and Social Care Trust | Belfast |
Lead Sponsor | Collaborator |
---|---|
Queen's University, Belfast | Belfast Health and Social Care Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Exploratory evaluation of correlation of effect of SGLT2 inhibition on novel cardiac biomarkers with markers of cardiac remodeling. | Correlation of log transformed delta change in novel cardiac biomarkers with global longitudinal strain [GLS (%)] and left ventricular ejection fraction [LVEF (%)]. | 26 weeks. | |
Other | Exploratory evaluation of correlation of effect of SGLT2 inhibition on novel cardiac biomarkers with markers of cardiac remodeling. | Correlation of log transformed delta change in novel cardiac biomarkers with change in left ventricular end systolic volume index [LVESVi (mls/m2)], left ventricular end diastolic volume [LVEDVi (mls/m2)] and left atrial volume [LAVi (mls/m2)]. | 26 weeks. | |
Other | Exploratory evaluation of correlation of effect of SGLT2 inhibition on novel cardiac biomarkers with qualitive markers of heart failure outcomes. | Correlation of log transformed delta change in novel cardiac biomarkers with change in Kansas-City Cardiomyopathy Questionnaire (KCCQ). | 26 weeks. | |
Other | Exploratory evaluation of correlation of effect of SGLT2 inhibition on novel cardiac biomarkers with qualitive markers of heart failure outcomes. | Correlation of log transformed delta change in novel cardiac biomarkers with change in Change in New York Heart Association (NYHA) score. | 26 weeks. | |
Primary | To evaluate whether SGLT2 inhibition in heart failure produces changes in novel cardiac biomarkers. | Assessment of changes in levels of novel biomarkers associated with heart failure, cardiac remodeling, or response to SGLT2i, including; KIM-1, IGFBP7, TNFR, IL-6, collagen IV, MMP7, FN1, sST2, LRG1, Tetranectin, collagen XIV (Olink and ELISA based analysis). Additional novel biomarkers may be added to this investigatory panel as the trial continues. | 26 weeks | |
Secondary | To evaluate if SGLT2 inhibition produces changes in markers of cardiac remodeling as assessed by echocardiography. | Changes in global longitudinal strain (GLS) (%) and left ventricular systolic function [LVEF (%)] as assessed on strain echocardiography. | 26 weeks | |
Secondary | To evaluate if SGLT2 inhibition produces changes in markers of cardiac remodeling as assessed by echocardiography. | Change in left ventricular end systolic volume index [LVESVi (mls/m2)], left ventricular end diastolic volume [LVEDVi (mls/m2)] and left atrial volume [LAVi (mls/m2)]. | 26 weeks | |
Secondary | To evaluate if SGLT2 inhibition produces changes in markers of cardiac remodeling as assessed by diastolic parameters on echocardiography. | Change in left ventricular lateral e' (cm/s), septal e' (cm/s) and E/e' ratio obtained from echocardiography. | 26 weeks | |
Secondary | To evaluate changes in quantitative markers of heart failure outcomes following initiation of SGLT2 inhibition in heart failure. | Changes in standard care cardiac biomarkers following SGLT2 inhibition including, N-terminal prohormone of brain natriuretic peptide [NT-proBNP (ng/L)] and high sensitivity troponin [hs-TnT (ng/L)]. | 26 weeks | |
Secondary | To evaluate changes in quantitative markers of heart failure outcomes following initiation of SGLT2 inhibition in heart failure. | Changes in standard care biomarker of inflammation following SGLT2 inhibition by measurement of serum C-reactive protein [CRP (mg/dL). | 26 weeks | |
Secondary | To evaluate changes in quantitative markers of heart failure outcomes following initiation of SGLT2 inhibition in heart failure. | Changes in standard care cardiac of diabetic biomarkers following SGLT2 inhibition using measurement of glycosylated haemoglobin [HbA1c (mmol/mol)]. | 26 weeks | |
Secondary | To evaluate changes in quantitative markers of heart failure outcomes following initiation of SGLT2 inhibition in heart failure. | Changes in standard care biomarkers of cardiovascular risk following SGLT2 inhibition including lipid profile as assessed by serum cholesterol (mmol/L) and serum low density lipoprotein [LDL (mmol/L)]. | 26 weeks | |
Secondary | To evaluate changes in qualitative markers of heart failure outcomes. | Change in New York Heart Association (NYHA) score, classified on a scale I to IV, with a higher number indicating a worse outcome. | 26 weeks. | |
Secondary | To evaluate changes in qualitative markers of heart failure outcomes. | Change in Kansas-City Cardiomyopathy Questionnaire (KCCQ) score following initiation of SGLT2 inhibition in heart failure. It contains four subdomains: Physical Limitation, Symptom Frequency, Quality of Life, and Social Limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status. A change of 5 points on the scale scores, either as a group mean difference or an intra-individual change is defined as clinically significant. | 26 weeks. |
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