Dapagliflozin With or Without Spironolactone for HFpEF

Sponsor
Universidade do Porto
Study ID
NCT05676684
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 15, 2022
Status verified
Mar 2025
Primary completion
Nov 29, 2024
Completion
Nov 29, 2024

Study Design

Enrollment
108 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: [Dapagliflozin] - [Dapagliflozin + Spironolactone]
    Drug will be administered according to sequence: Dapagliflozin \[week 1-12\] - Dapagliflozin + Spironolactone \[week 13-25\]
  • Experimental: [Dapagliflozin + Spironolactone] - [Dapagliflozin]
    Drug will be administered according to sequence: Dapagliflozin + Spironolactone \[week 1-12\] - Dapagliflozin \[week 13-25\]

Primary Outcome Measure

Blood levels of NT-pro BNP (Log transformed) [ Time Frame: Visit 1 Day 0 / Visit 2 Day 84 [Day 77 to Day 91] / Visit 3 Day 175 [Day 168 to Day 182] ]

Related Studies