EFFECT OF THE USE OF DAPAGLIFLOZIN IN DIURESIS, NATRIURIESIS AND IN ULTRAFILTRATION AND PERITONEAL ELIMINATION OF SODIUM, IN PATIENTS WITH REFRACTORY HEART FAILURE (DAPA-DP study)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- For the primary endpoint, we assume a mean sum between the natriuresis in 24 hours and the daily peritoneal dialytic sodium removal of 122 mEq. Treatment is estimated to increase values by an average of 15% to 140 mEq after treatment. Standard deviation from pretreatment and post treatment is 30 mEq. Assuming a two-sided paired t-test with alfa error of 0.05, power of 80% correlation between pre-post treatment of 0.7 and drop-out rate of 25%, the total sample size required is 30 patients.
研究概览
简要总结
To explore the effect of iSGLT2 in natriuresis and the peritoneal elimination of sodium in patients with CKD and refractory HF treated with peritoneal dialysis.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 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.
- •Provision of informed consent form prior to any study specific procedures, sampling and analysis.
- •Individuals must be ≥ 18 years of age at the time of signing the informed consent
- •Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).
- •In treatment with Peritoneal Dialysis technique
- •Chronic Kidney Disease (eGFR < 60 ml/min/m2 CKD-EPI formula)
- •PD vintage of more than 30 days
- •On stable doses of furosemide, or alternative loop diuretic for 14 days
- •On stable HF therapy for at least 1 month prior to consent
- •No hospitalizations for HF for at least 1 month prior to consent
排除标准
- •Limited life expectancy (less than 1 year) based on investigator’s clinical judgement.
- •Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information.
- •Malignancy (with active treatment) or other life-threatening disease
- •Patients in whom proper study compliance cannot be guaranteed
- •Rejection or revocation of informed consent
- •Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 1 month prior to enrollment.
- •Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement) within 1 month prior to enrollment or planned to undergo any of these operations after randomization.
- •Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 1 month prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.
- •Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
- •Pregnant or breast-feeding women
- •Type 1 Diabetes
- •Residual urine volume less than 500ml daily or reduction in urinary output by 24 hours (< 30% compared to previous routine control) within 30 days prior to consent
- •Patients with amputated limbs will be excluded of bioimpedance analysis.
- •Participation in another clinical study with an investigational product during the last 3 months.
- •Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product.
- •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.
- •Previous enrolment in the present study.
结局指标
主要结局
For the primary endpoint, we assume a mean sum between the natriuresis in 24 hours and the daily peritoneal dialytic sodium removal of 122 mEq. Treatment is estimated to increase values by an average of 15% to 140 mEq after treatment. Standard deviation from pretreatment and post treatment is 30 mEq. Assuming a two-sided paired t-test with alfa error of 0.05, power of 80% correlation between pre-post treatment of 0.7 and drop-out rate of 25%, the total sample size required is 30 patients.
For the primary endpoint, we assume a mean sum between the natriuresis in 24 hours and the daily peritoneal dialytic sodium removal of 122 mEq. Treatment is estimated to increase values by an average of 15% to 140 mEq after treatment. Standard deviation from pretreatment and post treatment is 30 mEq. Assuming a two-sided paired t-test with alfa error of 0.05, power of 80% correlation between pre-post treatment of 0.7 and drop-out rate of 25%, the total sample size required is 30 patients.
次要结局
未报告次要终点
研究者
UICEC
Scientific
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA