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SGLT2 Inhibitor

The Effect of Inflammation in Heart Failure

Phase 2
Waitlist Available
Led By Wunan Y Zhou, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2.5 years
Awards & highlights
No Placebo-Only Group

Summary

Background: Heart failure is a serious health condition. Researchers believe inflammation plays a role. They want to see if adding an additional heart drug to a person s treatment can help treat heart failure with preserved ejection fraction (HFpEF). Objective: To learn if chronic inflammation is high in heart failure and if taking dapagliflozin along with the standard of care medicines for 6 months will reduce inflammation and improve heart function in people with HFpEF. Eligibility: People aged 18 and older who have heart failure and qualify for dapagliflozin therapy. Healthy adult volunteers are also needed. Design: * Participants will be screened with: * Medical history * Physical exam * Heart function tests * X-ray scans of the heart and blood vessels. They may receive medicines to slow their heart rate or make their heart blood vessels bigger. An intravenous (IV) catheter will be placed in their arm to inject contrast. * Blood and urine tests * Participants will have up to 3 study visits. Some screening tests will be repeated. Participants will take one tablet of the study drug daily for 6 months. -Participants will have an imaging scan of their heart and blood vessels. They will receive a contrast and stress medicine through an IV to view blood supply. Participants will have a stress test that measures exercise ability. They will wear sticky pads on their chest, a blood pressure cuff, and a mask. They will also have a 6-Minute Walk Test. Participants will complete questionnaires about their symptoms and their health. Participants may be on the study for up to 6 months. They will have a follow-up phone call 1 month after treatment ends. ...

Eligible Conditions
  • Congestive Heart Failure
  • Inflammation and Pain
  • Heart Failure
  • Inflammation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
IL-1 beta levels
Secondary study objectives
Change in CMR, ECHO in affected vs healthy individuals
Immunological profiles in affected vs healthy individuals

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subjects with HFpEFExperimental Treatment3 Interventions
Subjects are defined as patients with a diagnosis of HFpEF clinically confirmed by a licensed physician or advanced practitioner who meet the inclusion and exclusion criteria and are able to provide informed consent.
Group II: ControlExperimental Treatment2 Interventions
Healthy volunteers who are age and sex matched
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI scan
2022
Completed Phase 4
~2710
Dapagliflozin
2014
Completed Phase 4
~64440

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,942 Previous Clinical Trials
47,793,238 Total Patients Enrolled
Wunan Y Zhou, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
1 Previous Clinical Trials
16 Total Patients Enrolled
~0 spots leftby Dec 2025