Heart Failure Clinical Trial
— EMAS-HFOfficial title:
Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure
Verified date | June 2023 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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
Status | Enrolling by invitation |
Enrollment | 40 |
Est. completion date | June 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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)## |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Amgen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the impact of SGLT2i on systemic metabolomic and proteomic profiles | 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. | 4-8 weeks | |
Secondary | Assess the impact of SGLT21 on ambulation | Differences in distance traveled during a standardized 6-minute walk test. Changes in systemic or skeletal muscle metabolism may improve walking distance. | 4-8 weeks | |
Secondary | Assess the impact of SGLT2i on skeletal muscle oxidative phosphorylation capacity (SkM OxPhos) | OxPhos as assessed using CrCEST MRI spectroscopy. SkM OxPhos is a major topic of interest for this proposal. We hypothesize that SGLT2i may improve skeletal muscle OxPhos. | 4-8 weeks | |
Secondary | Assess the impact of SGLT2i on skeletal muscle perfusion during exercise | MRI-based assessment of SkM Perfusion: Differences in conduit artery blood flow and intramuscular perfusion using vPIVOT MRI imaging. Changes in dynamic responses of SkM blood flow may be a contributor to the improvements in exercise tolerance we hypothesize will occur with SGLT2i | 4-8 weeks |
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