NCT05885607Active, not recruiting
Early Metabolic Adaptations to SGLT2 Inhibition in Heart Failure
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 10 May 2023
- Start date
- 27 Jun 2023
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- University of Pennsylvania
- Diseases
- Heart failure
- NCT number
- NCT05885607
What you commit to
- Study type: Observational
- Planned participants: 40
- From 27 Jun 2023 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance to an SGLT2 inhibitor
- Previous cardiac transplantation or implantation of a ventricular assist device
- ANY intracranial implants of any type other than dental fillings
- An intra-luminal implant, filter, stent, or valve replacement
Other illness
- Acute coronary syndrome or unstable angina within the past month
- 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 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.
- A cardiac pacemaker or implanted cardiac defibrillator (ICD)##
Other
- Subject inability/unwillingness to perform a six-minute walk test
- ANY non-removable piercings, jewelry, or medicinal patch
- 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):
- A vascular clip or clamp
- A surgically placed clip, clamp or band on visceral organs
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.