Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function
Key facts
- Where
- Angeles City, Cebu City, City of Taguig, Davao City, Iloilo City, Las Piñas, Mabalacat, Makati, Manadaluyong City, Manila, Marikina City, Pasig, Quezon City, Roxas City és West San Juan City, Fülöp-szigetekSee the 15 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 130 years old?
Forrás: NCT06307652: ki vehet részt
Where in Fülöp-szigetek
- Angeles CityAngeles City, Fülöp-szigetekTaking people
- Cebu CityCebu City, Fülöp-szigetekNo longer taking part
- City of TaguigCity of Taguig, Fülöp-szigetekTaking people
- Davao CityDavao City, Fülöp-szigetekTaking people
- Iloilo CityIloilo City, Fülöp-szigetekTaking people
- Las PiñasLas Piñas, Fülöp-szigetekTaking people
- MabalacatMabalacat, Fülöp-szigetekTaking people
- MakatiMakati, Fülöp-szigetekTaking people
- Manadaluyong CityManadaluyong City, Fülöp-szigetekTaking people
- ManilaManila, Fülöp-szigetekNo longer taking part
- Marikina CityMarikina City, Fülöp-szigetekTaking people
- PasigPasig, Fülöp-szigetekTaking people
- Quezon CityQuezon City, Fülöp-szigetekTaking people
- Roxas CityRoxas City, Fülöp-szigetekTaking people
- West San Juan CityWest San Juan City, Fülöp-szigetekTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06307652EU 2023-508162-15-00
- Record updated
- 2026. október 13.
- Original description
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.Read full original descriptionShow less
A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function
This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.
Inclusion: Age ≥ 18 years; Documented diagnosis of symptomatic HF (NYHA functional class II-IV); Having had a recent HF event within 6 months (hospitalization or urgent visit); Have a LVEF value from an assessment within the last 12 months; Managed with SoC therapy for HF and renal impairment according to local guidelines; NT-proBNP must be >300 pg/mL (>600 pg/mL if concomitant atrial fibrillation or atrial flutter); Not taking an MRA; An eGFR ≥ 20 to < 60 mL/min/1.73 m2; Serum/plasma potassium ≤ 5.0 mmol/L.
Exclusion: Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period; Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations; Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment; Kidney replacement therapy in the past 4 weeks, currently requiring kidney replacement or imminent plan to start kidney replacement therapy; Treatment with strong or moderate CYP3A4 inhibitor or inducer; History of hypertrophic obstructive cardiomyopathy; Complex congenital heart disease or severe uncorrected primary valvular disease; Symptomatic bradycardia or second- or third-degree heart block without a pacemaker; Type 1 diabetes mellitus; Acute or chronic liver disease with severe impairment of liver function, eg, ascites, oesophageal varices, coagulopathy, and encephalopathy; Suspected or confirmed COVID-19 infection within the last 4 weeks or hospitalisation for COVID-19 within the last 12 weeks; Systolic BP < 90 mmHg, or symptomatic hypotension within the past 24 hours.