Investigation of Biomarker Response to SGLT2 Inhibition Across Various Phenotypes of Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- To evaluate whether SGLT2 inhibition in heart failure produces changes in novel cardiac biomarkers.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate whether SGLT2 inhibition in heart failure produces changes in novel cardiac biomarkers.
时间窗: 26 weeks
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.
次要结局
- To evaluate if SGLT2 inhibition produces changes in markers of cardiac remodeling as assessed by echocardiography.(26 weeks)
- To evaluate if SGLT2 inhibition produces changes in markers of cardiac remodeling as assessed by diastolic parameters on echocardiography.(26 weeks)
- To evaluate changes in quantitative markers of heart failure outcomes following initiation of SGLT2 inhibition in heart failure.(26 weeks)
- To evaluate changes in qualitative markers of heart failure outcomes.(26 weeks.)
研究者
Chris Watson
Dr
Queen's University, Belfast