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Dapagliflozin With or Without Spironolactone for HFpEF

NCT05676684 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dapagliflozin

A: Dapagliflozin 10 mg once daily

DRUG

Spironolactone + Dapagliflozin

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

Sponsors & Collaborators

  • Centro Hospitalar De São João, E.P.E.

    collaborator OTHER

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

    collaborator OTHER_GOV

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • Adelino Leite-Moreira, MD, PhD · Universidade do Porto

  • Ricardo Fontes-Carvalho, MD, PhD · Unidade Local de Saúde Gaia/Espinho

  • João Ferreira, MD, PhD · Universidade do Porto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2024-11-29
Completion
2024-11-29

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05676684 on ClinicalTrials.gov