CTIS2023-505571-78-00招募中1 期
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)
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA0 个研究点目标入组 1 人开始时间: 2023年6月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. 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. 2. Provision of informed consent form prior to any study specific procedures, sampling and analysis. 3. Individuals must be = 18 years of age at the time of signing the informed consent 4. Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF). 5. In treatment with Peritoneal Dialysis technique 6. Chronic Kidney Disease (eGFR < 60 ml/min/m2 CKD-EPI formula) 7. PD vintage of more than 30 days 8. On stable doses of furosemide, or alternative loop diuretic for 14 days 9. On stable HF therapy for at least 1 month prior to consent 10. No hospitalizations for HF for at least 1 month prior to consent
排除标准
- •1. Limited life expectancy (less than 1 year) based on investigator’s clinical judgement. 2. Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information. 3. Malignancy (with active treatment) or other life-threatening disease 4. Patients in whom proper study compliance cannot be guaranteed 5. Rejection or revocation of informed consent 6. Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 1 month prior to enrollment. 7. 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. 8. 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. 9. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization 10. Pregnant or breast-feeding women 11. Type 1 Diabetes 12. 9. 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 13. Patients with amputated limbs will be excluded of bioimpedance analysis. 14. Participation in another clinical study with an investigational product during the last 3 months. 15. Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product. 16. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site). 17. 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. 18. Previous enrolment in the present study.
研究者
相似试验
进行中（未招募）
4 期
Effect of the Use of Dapagliflozin in Patients With Refractory Heart FailureHeart FailureNCT06578520Fundación para la Investigación del Hospital Clínico de Valencia31
尚未招募
Unknown
TO ASSESS EFFICACY OF DAPAGLIFLOZIN IN PATIENTS WITH CIRRHOSIS WITH DIABETES AS COMPARED TO STANDARD MEDICAL REGIMECTRI/2023/06/054459Pt BD Sharma Institute of Medical Science, Rohtak
进行中（未招募）
3 期
DAPAgliflozin Versus Thiazide Diuretic in Patients With Heart Failure and Diuretic RESISTanceHeart FailureNCT04860011NHS Greater Glasgow and Clyde61
已完成
不适用
The effect of empagliflozin on diuresis and neurohumoral factors in the patients with decompensated heart failure and diabetes mellitus: pilot studydecompensated heaat failure type 2 diabetes mellitusJPRN-UMIN000027431Department of Cardiology, National Hospital Organization Yokohama Medical Center15
招募中
4 期
Dapagliflozin in Chronic Heart failure patientChronic Heart Failure.Chronic combined systolic (congestive) and diastolic (congestive) heart failureI50.42IRCT20230331057788N1ational University of Medical Sciences170