2025-520550-11-00尚未招募2 期
Swedish Cardiac And Renal Failure study-1 (SCARF-1): An open-label pilot trial to evaluate the feasibility, safety and efficacy of eplerenone in patients with heart failure with reduced ejection fraction and severe chronic kidney disease.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary endpoint is the proportion of subjects who complete the entire treatment period with and without the need to use a potassium binder.
研究概览
简要总结
To conduct a pilot trial to evaluate the feasibility and safety of eplerenone in patients with HFrEF and severe CKD. An exploratory analysis of efficacy will also be performed.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The subject has given their written consent to participate
- •A diagnosis of HFrEF according to current criteria since at least three months prior to the screening visit
- •Echocardiography within 24 months of the screening visit with EF ≤ 40%
- •New York Heart Association class II-III
- •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
- •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
排除标准
- •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)
- •QTc(f) ≥ 550 msec, history of QT prolongation associated with any medication requiring medication discontinuation, or congenital long QT syndrome
- •Uncontrolled arrythmia as judged by the investigator
- •Acute cardiac hospitalization or procedure within four weeks
- •Acute cardiac hospitalization or procedure within four weeks before inclusion
- •Not suitable as judged by the investigator (presumed inability to participate, severe or terminal co-morbidity and expected survival < 12 months)
- •Previously enrolled in this trial or participation in another trial not approved for co-enrollment
- •eGFR < 10 ml/min/1.73m2 according to the revised Lund-Malmö method.
- •Ongoing/planned dialysis
- •Systolic blood pressure < 90 mmHg
- •Uncontrolled hypertension as judged by the investigator
- •Severe hepatic impairment (Child-Pugh C)
- •History of, or planned, heart transplantation or left ventricular assist device
- •Unwillingness to comply with highly effective contraceptive methos, or ongoing/planned pregnancy or breastfeeding
- •Previous allergic reaction to a MRA or a potassium binder
结局指标
主要结局
The primary endpoint is the proportion of subjects who complete the entire treatment period with and without the need to use a potassium binder.
The primary endpoint is the proportion of subjects who complete the entire treatment period with and without the need to use a potassium binder.
次要结局
- Safety endpoint: Cardiovascular (CV) death
- Safety endpoint: All cause death
- Safety endpoint: Hospitalization for hyperkalemia
- Safety endpoint: The occurrence of P-K < 3.0
- Safety endpoint: Hospitalization for hypokalemia
- Safety endpoint: Decrease in eGFR of ≥ 30% and ≥ 50%
- Safety endpoint: Hospitalization for renal failure
- Safety endpoint: Initiation of dialysis
- Safety endpoint: Subject-reported syncope
- Safety endpoint: All cause hospitalization
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) total symptom score
- Change in six-minute walk distance (6MWD)
- Change in N-terminal pro b-type natriuretic peptide (NTpro-BNP)
- Change in eGFR and urine-albumin-creatinine-ratio (UACR)
- Safety endpoint: The occurrence of plasma potassium (P-K) ≥ 5.5 and ≥ 6.0
- Safety endpoint: Subject-reported lightheadedness due to orthostatic hypotension as judged by the investigator
- Safety endpoint: Any subject-reported side effect
- Safety endpoint: Hospitalization for HF
研究者
Krister Lindmark
Scientific
Karolinska Institutet
研究点 (1)
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