Altizide; Micronised spironolactone for Heart failure with reduced ejection fraction | Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- The subject has given their written consent to participate"}
• {"criterion_text":"- Age ≥ 18"}
• {"criterion_text":"- A diagnosis of HFrEF according to current criteria since at least three months prior to the screening visit"}
• {"criterion_text":"- Echocardiography within 24 months of the screening visit with EF ≤ 40%"}
• {"criterion_text":"- New York Heart Association class II-III"}
• {"criterion_text":"- Optimally treated and stable HFrEF (according to the investigator) since at least four weeks before the screening visit. Treatment should include BBs, SGLT2Is, ACEIs, or ARBs if eGFR ≥ 20 ml/min/1.73m2 according to the revised Lund-Malmö method. 20 Participants should also have cardiac resynchronization therapy or an implantable cardioverter-defibrillator if the indication exists according to current guidelines"}
• {"criterion_text":"- eGFR < 30 ml/min/1.73m2 according to the revised Lund-Malmö method at least once during the 12 months prior to the screening visit and eGFR < 45 ml/min/1.73m2 at the time of inclusion"}

Exclusion criteria

• {"criterion_text":"- P-K ≥ 5.5"}
• {"criterion_text":"- Ongoing treatment with lithium, cyclosporine, tacrolimus, nonsteroidal anti-inflammatory drugs, trimethoprim or strong CYP3A inhibitors (ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone) or inducers (rifampicin, carbamazepine, phenytoin, phenobarbital and St. John’s worth)"}
• {"criterion_text":"- QTc(f) ≥ 550 msec, history of QT prolongation associated with any medication requiring medication discontinuation, or congenital long QT syndrome"}
• {"criterion_text":"- Uncontrolled arrythmia as judged by the investigator"}
• {"criterion_text":"- Acute cardiac hospitalization or procedure within four weeks"}
• {"criterion_text":"- Acute cardiac hospitalization or procedure within four weeks before inclusion"}
• {"criterion_text":"- Not suitable as judged by the investigator (presumed inability to participate, severe or terminal co-morbidity and expected survival < 12 months)"}
• {"criterion_text":"- Previously enrolled in this trial or participation in another trial not approved for co-enrollment"}
• {"criterion_text":"- eGFR < 10 ml/min/1.73m2 according to the revised Lund-Malmö method."}
• {"criterion_text":"- Ongoing/planned dialysis"}
• {"criterion_text":"- Systolic blood pressure < 90 mmHg"}
• {"criterion_text":"- Uncontrolled hypertension as judged by the investigator"}
• {"criterion_text":"- Severe hepatic impairment (Child-Pugh C)"}
• {"criterion_text":"- History of, or planned, heart transplantation or left ventricular assist device"}
• {"criterion_text":"- Unwillingness to comply with highly effective contraceptive methos, or ongoing/planned pregnancy or breastfeeding"}
• {"criterion_text":"- Previous allergic reaction to a MRA or a potassium binder"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the proportion of subjects who complete the entire treatment period with and without the need to use a potassium binder.","definition_or_measurement_approach":"Measured as the proportion of subjects who complete the entire treatment period, reported with and without the need to use a potassium binder."}

Secondary endpoints

• {"endpoint_text":"- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Change in six-minute walk distance (6MWD)","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Change in N-terminal pro b-type natriuretic peptide (NTpro-BNP)","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Change in eGFR and urine-albumin-creatinine-ratio (UACR)","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: The occurrence of plasma potassium (P-K) ≥ 5.5 and ≥ 6.0","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Hospitalization for hyperkalemia","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: The occurrence of P-K < 3.0","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Hospitalization for hypokalemia","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Decrease in eGFR of ≥ 30% and ≥ 50%","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Hospitalization for renal failure","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Initiation of dialysis","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Subject-reported syncope","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Subject-reported lightheadedness due to orthostatic hypotension as judged by the investigator","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Any subject-reported side effect","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Hospitalization for HF","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: All cause hospitalization","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: Cardiovascular (CV) death","definition_or_measurement_approach":"Not specified"}
• {"endpoint_text":"- Safety endpoint: All cause death","definition_or_measurement_approach":"Not specified"}

Sweden

Latest Decision Or Authorization Date

26-01-2026

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Karolinska Institutet

Organisation Type

Educational Institution

Country Of Registered Address

Sweden