Heart Failure
Conditions
Keywords
Finerenone, SGLT2 inhibitor, Dapagliflozin, Heart failure therapy, Cardioprotection
Brief summary
The goal of this clinical study is to evaluate whether adding finerenone to standard treatment with a sodium-glucose cotransporter-2 (SGLT2) inhibitor provides additional benefits in patients with heart failure. The main question this study aims to answer is whether the combination of finerenone and an SGLT2 inhibitor improves clinical outcomes and is safe compared to treatment with an SGLT2 inhibitor alone. Participants will receive standard therapy with an SGLT2 inhibitor, with or without the addition of finerenone and will be followed to assess clinical outcomes and safety.
Detailed description
Heart failure is a chronic clinical syndrome associated with significant morbidity, mortality and healthcare burden worldwide, despite advances in pharmacological therapy. Sodium-glucose cotransporter-2 (SGLT2) inhibitors have become an important component of standard treatment for patients with heart failure due to their demonstrated cardiovascular benefits. However, a substantial residual cardiovascular risk persists, indicating the need for additional therapeutic strategies. Finerenone is a nonsteroidal mineralocorticoid receptor antagonist with a distinct mechanism of action that targets mineralocorticoid receptor activation in cardiac and renal tissues. Previous clinical studies have demonstrated that finerenone reduces inflammation and fibrosis and provides cardiovascular benefits in patients with chronic cardiovascular and renal diseases. These findings support the potential for finerenone to offer complementary cardioprotective effects when combined with established heart failure therapies. This prospective controlled pilot study is designed to evaluate the clinical effects and safety of adding finerenone to standard therapy with an SGLT2 inhibitor in patients with heart failure, compared with treatment using an SGLT2 inhibitor alone. Patients receiving stable SGLT2 inhibitor therapy will be managed according to the assigned treatment strategy and followed throughout the study period to evaluate overall clinical outcomes and safety parameters. The findings of this pilot study are expected to provide preliminary evidence regarding the potential benefits and tolerability of combining finerenone with SGLT2 inhibitors in patients with heart failure and to inform the design of future larger-scale clinical studies.
Interventions
DRUGFinerenone
Finerenone administered orally at a dose of 10 mg once daily.
DRUGdapagliflozine
Dapagliflozin administered orally at a dose of 10 mg once daily.
Sponsors
Mansoura University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged 18 - 65 years. * Newly diagnosed with HFrEF or HFpEF. * Clinically stable and eligible to start SGLT2 inhibitors ± Finerenone therapy.
Exclusion criteria
* Patients with stroke. * eGFR \<25 mL/min. * HF secondary to congenital heart disease or pulmonary hypertension * Use intravenous inotropes. * Patients needing cardiac transplantation. * Known allergy to study medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Mortality and Heart Failure Hospitalization | Up to 12 weeks (assessed at Baseline, Week 4, and Week 12) | Incidence of cardiovascular mortality and hospitalization due to heart failure in each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Mortality | Up to 12 weeks (assessed at Baseline, Week 4, and Week 12) | Number of participants with all-cause mortality in each treatment group. |
| Change in NYHA Functional Class | Up to 12 weeks (assessed at Baseline, Week 4, and Week 12) | Change in New York Heart Association (NYHA) functional class in each treatment group. |
| Change in Serum Potassium Level | Up to 12 weeks (assessed at Baseline, Week 4, and Week 12) | Serum potassium concentration (mmol/L) measured at baseline, Week 4 and Week 12 in each treatment group. |
| Change in Estimated Glomerular Filtration Rate (eGFR) | Up to 12 weeks (assessed at Baseline, Week 4, and Week 12) | Estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) measured at baseline, Week 4 and Week 12 in each treatment group. |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | Baseline and Week 12 | Change in health-related quality of life assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score in each treatment group. Scores range from 0 to 100, with higher scores indicating better quality of life. |
Countries
Egypt
Contacts
CONTACTMansour Saad Alqahtani, PhD Candidate
CONTACTMoheb Magdy Wadie, Phd
PRINCIPAL_INVESTIGATORMansour Saad Alqahtani, PhD Candidate
Faculty of pharmacy, Mansoura university
Outcome results
None listed