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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Dapagliflozin in PRESERVED Ejection Fraction Heart Failure (PRESERVED-HF Trial)

Phase 4
Waitlist Available
Research Sponsored by Saint Luke's Health System
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 baseline to week 12
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial will compare the effect of dapagliflozin to placebo on heart failure, biomarkers, symptoms, health status, and quality of life in patients with chronic heart failure with preserved systolic function.

Eligible Conditions
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS)
Secondary study objectives
Effect of Dapagliflozin, as Compared With Placebo, on 6 Minute Walk Test Distance
Nesiritide
Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS)
+7 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: DapagliflozinActive Control1 Intervention
Dapagliflozin 10 mg oral tablet, once daily, for 12 weeks
Group II: PlaceboPlacebo Group1 Intervention
Dapagliflozin matching placebo oral tablet, once daily, for 12 weeks

Find a Location

Who is running the clinical trial?

Saint Luke's Health SystemLead Sponsor
41 Previous Clinical Trials
12,622 Total Patients Enrolled
7 Trials studying Heart Failure
829 Patients Enrolled for Heart Failure
Mikhail Kosiborod, MDStudy ChairSaint Luke's Mid America Heart Institute
4 Previous Clinical Trials
4,817 Total Patients Enrolled
2 Trials studying Heart Failure
328 Patients Enrolled for Heart Failure
~37 spots leftby Jan 2026
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