Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Assess the impact of SGLT2i on systemic metabolomic and proteomic profiles
研究概览
简要总结
The goal of this observational study is to learn about SGLT2 inhibition medications in patients with symptomatic heart failure who are clinically prescribed FDA-approved SGLT2 inhibitors. The main question it aims to answer is:
- What are the impacts of SGLT2 inhibition on systemic metabolomic and proteomic profiles? Participants will be asked to do the following before and after being prescribed a SGLT2i.
- Six-minute walk testd
- Calf MRI with plantar flexion exercise
- Blood sample collection
详细描述
Schema
Total anticipated enrollment: 40 participants This is an observational study in patients being initiated on an FDA-approved SGLT2i treatment for symptomatic HF (on-label use). This observational study involves supplemental research testing before and after SGLT2i initiation to help define how the treatment affects the body.
Study Design
This will be a single-center study that will characterize early changes in systemic metabolic and proteomic profiles, skeletal muscle oxidative capacity and six-minute walk distance before and after initiation of SGLT2i treatment. The paired study design will specifically target patients with symptomatic heart failure whose physicians are prescribing FDA-approved SGLT2i treatment. Pre- vs. post-treatment profiling will be performed during the first 4-8 weeks of therapy. Eligibility is not limited to a particular range of LVEF or affected by prior LVEF.
Visit Procedures
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Clinically diagnosed HF documented in the patient's medical record
- •NYHA Class II-III functional status, according to the most recent clinical evaluation
- •Availability of an echocardiogram or cardiac MRI within the prior year
- •Stable HF medical therapy (no change in beta-blocker, ACE/ARB, ARNI or MRA for at least 4 weeks prior to screening) with the exception of diuretics
- •Planned initiation of on-label SGLT2i therapy
排除标准
- •Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance to an SGLT2 inhibitor
- •Subject inability/unwillingness to perform a six-minute walk test
- •Acute coronary syndrome or unstable angina within the past month
- •Previous cardiac transplantation or implantation of a ventricular assist device
- •Any condition that will interfere with the completion of the study. This may include comorbid conditions or logistical factors that may impede successful completion of the protocol (e.g. inability to travel for follow-up visits)
- •Absolute Exclusions for the Leg MRI Assessment (may still participate in blood sampling and six-minute walk testing):
- •ANY intracranial implants of any type other than dental fillings
- •ANY non-removable piercings, jewelry, or medicinal patch
- •ANY personal history of intraocular injury or fragment in or around the orbit that cannot be cleared through radiologic examination
- •ANY personal history of bullet, shrapnel, or stabbing wounds that cannot be cleared through radiologic evaluation.
- •ANY non-removable life assist device, pump, or prosthetic
- •Possible Exclusions** for the Leg MRI Assessment (may still participate in blood sampling and six-minute walk testing):
- •An intra-luminal implant, filter, stent, or valve replacement
- •A vascular clip or clamp
- •A surgically placed clip, clamp or band on visceral organs
- •A cardiac pacemaker or implanted cardiac defibrillator (ICD)##
结局指标
主要结局
Assess the impact of SGLT2i on systemic metabolomic and proteomic profiles
时间窗: 4-8 weeks
We will measure changes in venous concentrations of metabolic substrates and intermediates, along with circulating proteomic regulators using both targeted and untargeted surveys. SGLT2i has been shown to impact glucose, fatty acid, and ketone metabolism.
次要结局
- Assess the impact of SGLT21 on ambulation(4-8 weeks)
- Assess the impact of SGLT2i on skeletal muscle perfusion during exercise(4-8 weeks)
- Assess the impact of SGLT2i on skeletal muscle oxidative phosphorylation capacity (SkM OxPhos)(4-8 weeks)
研究者
Kenneth B Margulies
M.D.
University of Pennsylvania