Dapagliflozin With or Without Spironolactone for HFpEF

Inclusion Criteria

• •1. Provision of informed consent prior to any study specific procedures
• •2. HFpEF diagnosis\* (irrespective of time since diagnosis)
• •3. Male or female patients, aged ≥50 years
• •4. NYHA Class II-IV
• •5. LVEF \> 40%
• •6. NT-pro BNP ≥220 pg/mL or BNP ≥80 pg/mL if in sinus rhythm (SR)
• •7. NT-pro BNP ≥660 pg/mL or BNP ≥240 pg/mL if in atrial fibrillation (AF)
• •8. Echocardiography with at least one of the following criteria:
• •1. LAVI ≥29 ml/m2 (≥34 ml/m2 if AF)
• •2. Lateral E/e' ≥9
• •3. LVMI ≥115 g/m2 If male or ≥95 g/m2 if female
• •4. LV wall thickness ≥12mm
• •9. eGFR ≥30 ml/min/1.73m2 (CKD-EPI formula)
• •10. Blood Potassium ≤5.5 mmol/L
• •11. Not treated with MRAs and/or SGLT2i within the previous two weeks before inclusion and have no history of diabetic ketoacidosis while in treatment with SGLT2 inhibitors
• •12. Stable/chronic ambulatory patients i.e., patients without need for hospitalization within the last 30 days due to heart failure decompensation episodes
• •13. If female, she must be a woman of non-childbearing potential. That is, she must be:
• •1. Surgically sterilized (e.g. underwent hysterectomy, bilateral salpingectomy or bilateral oophorectomy)
• •2. Clinically diagnosed infertile
• •3. In a post-menopausal state, defined as no menses for 12 months without an alternative medical cause.
• •14. A female patient of childbearing potential must have a negative serum pregnancy test at Visit 1 (Day 0) and must agree to use consistently and correctly (from 28 days prior to first study treatment administration until at least 7 days after last study treatment administration) one of the following highly effective methods of contraception:
• •1. Abstinence of heterosexual intercourse (when this is in line with preferred and usual lifestyle of the subject)
• •2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
• •3. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
• •4. Intrauterine device
• •5. Intrauterine hormone-releasing system
• •6. Bilateral tubal occlusion
• •7. Vasectomized partner, who has received medical assessment of the surgical success, or clinically diagnosed infertile partner