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NCT03877224 · ClinicalTrials.gov registry record · Phase 3

DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
504
Enrollment target

NCT03877224: Completed Phase 3 study, sponsored by AstraZeneca.

NCT03877224 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 504 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03877224, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
504 participants
Enrollment target

Study Summary

International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)

Primary Outcome

Change from baseline in KCCQ-TSS was defined as the endpoint value at week 16 minus the baseline value. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ-TSS incorporates symptom frequency (4 items) and symptom burden (3 items) domains into a single score. The score is transformed to a range of 0-100 (higher score reflects better health status

Interventions

  • OTHER Placebo
  • DRUG Dapagliflozin

Trial Details

FieldValue
Enrollment Target 504 participants
Start Date 2019-04-04
Est. Completion 2020-07-09
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT03877224 record still lists

NCT03877224 is an interventional study that assigns participants to a tested intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03877224 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03877224 about?

NCT03877224 is a clinical study titled "DETERMINE-preserved - Dapagliflozin Effect on Exercise Capacity Using a 6-minute Walk Test in Patients With Heart Failure With Preserved Ejection Fraction". International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)

What is the current status of trial NCT03877224?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 504 participants. The study started on 2019-04-04. Estimated completion is 2020-07-09.

What interventions are being tested in trial NCT03877224?

The interventions under investigation include: Placebo (OTHER), Dapagliflozin (DRUG).

Who is sponsoring clinical trial NCT03877224?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03877224's enrollment target sits among peer trials

504 742nd of 2000 higher than 1,258 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03877224, the US trial registry maintained by the National Library of Medicine. NCT03877224 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.