Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure (NCT05885607) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure
United States40 participantsStarted 2023-06-27
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 woun…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess the impact of SGLT2i on systemic metabolomic and proteomic profiles