CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 108 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05676684
NCT05676684Phase 3Completed

SOdium-Glucose Cotransporter 2 Inhibitor With and Without an ALDosterone AntagonIst for Heart Failure With Preserved Ejection Fraction: a Two-centre Randomised Crossover Trial

Universidade do Porto·interventional·Posted Jan 9, 2023·Updated Aug 17, 2025

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin and Spironolactone + Dapagliflozin for Heart Failure With Preserved Ejection Fraction. Completed, enrolled 108 participants across 2 sites.

Detailed Summary

Heart failure (HF) is a condition in which the heart does not contract ("pump") or relax well, leading to insufficient perfusion of vital organs. Ankle swelling, fatigue, and breathlessness are some of the features of this syndrome. There are different causes for HF (eg., infarct and hypertension) and two distinct types: HFrEF - HF with reduced ejection fraction - where the heart does not "pump" properly, and HFpEF - HF with preserved ejection fraction - the heart "pumps" but does not relax well. Treatment for HFrEF is better established than for HFpEF. In HFpEF, only mineralocorticoid receptors antagonists (MRAs) have been shown to reduce hospitalizations, circulating markers of cardiac dysfunction and fibrosis, and blood pressure. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are a therapeutic class that reduces morbidity and mortality in patients with high cardiovascular risk and diabetes and in patients with HFrEF with and without diabetes. Trials are underway to test whether SGLT2i may also be useful for the treatment of HFpEF. This work aims to compare the effects of SGLT2i alone and in combination in an MRA in patients with HFpEF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPortugal

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJan 9, 2023
Enrollment StartSep 15, 2022
Primary CompletionNov 29, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 3.5 years ago

Interventions

Dapagliflozindrug

A: Dapagliflozin 10 mg once daily

Spironolactone + Dapagliflozindrug

C: Dapagliflozin 10 mg once daily plus Spironolactone 25mg/every other day or 25mg/day (can be adjusted according to potassium and renal function)