2024-513971-42-00招募中3 期
A Randomized Clinical Trial, Multicentre, Open-label, Parallel-group, to define the best Strategy for the management of hEart failure aNd chronic kidney disease among elderly patients with or at high risk of hyperKalemia in spAin by optimizing the use of RAASi with SZC: SENEKA Study
Hospital Clinico Universitario De Valencia6 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年8月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 6
- 主要终点
- Number of patients increasing at least 25% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9), considering the target dose of each RAASi drug in the ESC guidelines (1).
研究概览
简要总结
To comparethe number of patients achieving an increase of at least 25% of RAASi according to guideline-recommended target doses, in the arm treated with Lokelma plus RAASi versus the arm treated with RAASi without K+ binder, at 3 months after study inclusion.
研究设计
- 分配方式
- Randomized
- 主要目的
- Seneka Trial
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Hyperkalemic patients (sK+ 5.1–5.9 mmol/L at screening / study enrolment) or Normokalemic
- •Provision of informed consent form prior to any study specific procedures, sampling and analysis.
- •Individuals must be ≥ 70 years of age at the time of signing the informed consent form.
- •Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).
- •Individuals must have previously been admitted to hospital due to HF decompensation requiring intravenous diuretics.
- •Individuals must have been stabilised for at least 24-48h of their HF decompensation before randomisation.
- •Individuals must have a confirmed diagnosis of Chronic Kidney Disease defined as a renal impairment of eGFR less than 60ml/min/1.73 m
- •Individuals receiving background standard of care for HF and treated according to international guidelines. Specific treatment should include RAASi and/or MRA treatment and at least should have been stable for ≥ 4 weeks at maximum tolerated doses.
- •Patients on RAASi blocker treatment with less than or equal to 75% of the maximum recommended dose.
排除标准
- •Limited life expectancy (less than 1 year) according to clinician’s criteria, such as but not limited to malignancy, with life expectancy of less than 2 years based on investigator’s clinical judgement.
- •Congenital long QT syndrome.
- •Prior history of hypersensitivity to a RAAS blocker drug, including but not limited to development of angioedema, icterus, hepatitis, or neutropenia or thrombocytopenia requiring treatment modification. Addison’s disease or other causes of hypoaldosteronism.
- •Patients with a known hypersensitivity to SZC or any of the excipients of the product.
- •Individuals treated with potassium binding resins such as sodium polystyrene sulfonate (SPS, e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®) within 7 days prior to the first dose of study drug.
- •Treated with potassium supplements within 7 days prior to randomization.
- •Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.
- •Known to have tested positive for human immunodeficiency virus.
- •Known history of drug or alcohol abuse within 3 year of screening.
- •Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
- •Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
- •sK >6 mEq/litre or <4.5mEq/litre or history of hypokalemic episodes (S-K<3.5 mEq/L) during the last year.
- •Previous enrolment in the present study.
- •Participation in another clinical study with an investigational product during the last 3 months.
- •Patients on haemodialysis or haemofiltration
- •NYHA functional class IV
- •Patients undergoing treatment with potassium binders.
- •Active tumour undergoing chemotherapy or metastasis or malignancy requiring treatment.
- •Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
- •QTc(f) > 550 msec.
- •History of QT prolongation associated with other medications that required discontinuation of that medication.
结局指标
主要结局
Number of patients increasing at least 25% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9), considering the target dose of each RAASi drug in the ESC guidelines (1).
Number of patients increasing at least 25% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9), considering the target dose of each RAASi drug in the ESC guidelines (1).
次要结局
- Proportion of patients in each group requiring down titration of RAASi and/or MRA over the study period.
- Number of patients achieving the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9), considering the target dose of each RAASi drug recommended in the ESC guidelines
- Proportion of patients presenting more than one clinical event over the study period
- Number of patients achieving at least 50% of the target doses of RAASi since the screening visit (V0) to 3 months after study inclusion (V9), considering the target dose of each RAASi drug recommended in the ESC guidelines.
- Number of patients increasing 50% of RAASi doses since the screening visit (0) to 3 months after study inclusion (V9), considering the target dose of each RAASi drug recommended in the ESC guidelines.
- Number of patients achieving at least 50% of the target doses of MRA since the screening visit (V0) to 3 months after study inclusion (V9), considering the target dose of each MRA drug recommended in the ESC guidelines.
- Number of patients increasing 50% of MRA doses since the screening visit (V0) to 3 months after study inclusion (V9), considering the target dose of each MRA drug recommended in the ESC guidelines
- Number of patients achieving at least 50% of the target doses of MRA and RAASi since the screening visit (0) to 3 months after study inclusion (V9), considering the target dose recommended in the ESC guidelines
- Number of patients increasing 50% of MRA and RAASi doses since the screening visit (V0) to 3 months after study inclusion (V9), considering the target dose of each drug recommended in the ESC guidelines
- Proportion of patients in each group that required up titration of RAASi and/or MRA following down titration of RAASi and/or MRA.
- Proportion of patients in each group requiring discontinuation of RAASi and/or MRA over the study period.
- Number of patients achieving at least 50% of the target doses of RAASi since the screening visit (V0) to 1 month after study inclusion, considering the target dose of each RAASi drug recommended in the ESC guidelines
- Number of patients increasing 50% of RAASi doses since the screening visit (V0) to 1 month after study inclusion, considering the target dose of each RAASi drug recommended in the ESC guidelines
- Number of patients achieving a decrease of at least 5% in NT-proBNP levels since the baseline visit (V1) to 3 months after study inclusion (V9).
- Mean Change in NT-proBNP levels since the baseline visit (V1) to 3 months after study inclusion (V9).
- Number of patients achieving a decrease of at least 5% in CA125 levels since the baseline visit (V1) to 3 months after study inclusion (V9).
- Mean Change in CA125 levels since the baseline visit (V1) to 3 months after study inclusion (V9).
- Mean change on Systolic arterial blood pressure measurement from baseline visit (V1) to 3 months after study inclusion (V9).
- Mean change from baseline visit (V1) measured at 3 months after study inclusion (V9) in the overall summary score of KKCQ, as a specific HF patient reported outcome questionnaire.
- To determine the change in renal function the following variables will be calculated between baseline visit (V1) and 3 months after study inclusion (V9): Mean Change in UACR and Mean change in HCO3
- Number of patients decreasing at least 40% the eGFR since the screening visit (0) to 3 months after study inclusion (V9).
- Mean change from baseline visit (V1) measured at 3 months after study inclusion (V9) (V9) in the overall summary score of KDQoL, as a specific CKD patient reported outcome questionnaire.
- Number of visits for HF/HK/impaired renal function/hypertension or hyperkalemia diagnosed in the outpatient clinic.
- Proportion of patients requiring hospitalization for HF/HK/impaired renal function over the study period.
- Mean number of hospitalizations per patient for HF/HK/impaired renal function over the study period.
- Proportion of patients presenting at least one clinical event over the study period
- Proportion of patients presenting all clinical events over the study period
- Percentage of patients treated with and without sodium-glucose cotransporter-2 (SGLT2) inhibitors over the study period in both arms
- Mean Change in Mg levels since the baseline visit (V1) to 3 months after study inclusion (V9).
研究者
Clara Bonanad Lozano
Scientific
Hospital Clinico Universitario De Valencia
研究点 (6)
Loading locations...
相似试验
招募中
2 期
A phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with Tafasitamab (MOR208) for patients aggressive Lymphoma.2024-514775-17-00Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR64
招募中
2 期
Study that aims to investigate how effective and safe the use of a novel modified release tablet formulation of Colesevelam hydrochloride-MMX is for patients with idiopathic bile acid diarrhoea (BAD), randomly allocated to 2 different dose regimens of the active product or to the inactive placebo formulation.2024-511993-55-00Cosmo Technologies Limited120
撤回
3 期
A phase III, randomised, double-blind, multicentre study comparing the efficacy, safety, and immunogenicity of proposed tocilizumab biosimilar (DRL_Tocilizumab) with tocilizumab reference product (RoActemra®) administered by the subcutaneous route as an add-on to methotrexate in the treatment of patients with moderate to severe rheumatoid arthritis2022-501361-44-00Dr. Reddy's Laboratories Limited357
招募中
2 期
A Phase II Study of PEG-rhGH Injection for Short Children Born Small for Gestational Age: Efficacy, Safety, and PharmacokineticsNCT07260500Changchun GeneScience Pharmaceutical Co., Ltd.72
招募中
4 期
Efficacy, tolerability and preferences of per oral or subcutaneous methotrexate in patients with early rheumatoid arthritis – a randomised register based multicentre studyRheumatoid arthritis2024-512453-25-00Region Vaesterbotten212