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임상시험 NCT04841304 (CADDY)은(는) 투석 중인 말기 신장 질환, 심장 부정맥, 당뇨병, 저혈당증에 대해 진행중, 모집종료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Cardiac Arrhythmia in Patients with End-Stage Renal Disease (CADDY) 70
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임상시험 NCT04841304 (CADDY)은(는) 투석 중인 말기 신장 질환, 심장 부정맥, 당뇨병, 저혈당증에 대해 알아보는 관찰연구입니다. 현재 상태는 진행중, 모집종료이며, 연구는 2021년 6월 1일에 시작되어 70명의 참여자를 모집하고 있습니다. Rigshospitalet, Denmark이(가) 진행하며, 2026년 4월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 11월 18일에 갱신되었습니다.
간단한 개요
The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure.
The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 p...
더 보기공식 제목
Cardiac Arrhythmia in Patients with End-Stage Renal Disease
질환명
투석 중인 말기 신장 질환심장 부정맥당뇨병저혈당증출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- CADDY
- H-20069767
NCT 번호
실제 연구 시작일
2021-06-01
최신 업데이트 게시
2024-11-18
예상 연구 완료일
2026-04
계획된 등록 인원
70
연구종류
관찰연구
상태
진행중, 모집종료
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
Patients receiving hemodialysis with diabetes Patients receiving chronic hemodialysis with a diagnose of Type 1 diabetes or Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) and receiving glucose-lowering treatment | Loop recorder (Reveal LINQ, Medtronic) Implantation of a loop-recorder Continuous Glucose Measurement (G6, Dexcom) Monitoring with a continuous glucose monitor |
Patients receiving hemodialysis without diabetes Patients receiving chronic hemodialysis without diabetes (no known diagnosis of diabetes, and HbA1c \< 48 mmol/mol at inclusion) | Loop recorder (Reveal LINQ, Medtronic) Implantation of a loop-recorder Continuous Glucose Measurement (G6, Dexcom) Monitoring with a continuous glucose monitor |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Clinically significant arrhythmias | Presence of one of the items in the combined endpoint of clinically significant arrhythmias defined as:
* Significant bradyarrhythmia (pause \> 3 seconds or ≥ 4 beats at rate \< 30 beats/min)
* Ventricular tachycardia (lasting ≥ 16 beats at rate ≥ 150 beats/min)
* Ventricular fibrillation | 18 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Atrial fibrillation | Presence of atrial fibrillation (lasting ≥ 2 minutes) | 18 months |
Supraventricular tachycardia other than atrial fibrillation | Presence of supraventricular tachycardia other than atrial fibrillation (lasting ≥ 16 beats at rate ≥ 150 beats/min) | 18 months |
Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively | Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively | 18 months |
Characterization of arrhythmias in terms of onset | Characterization of arrhythmias in terms of onset | 18 months |
Characterization of arrhythmias in terms of duration | Characterization of arrhythmias in terms of duration | 18 months |
Characterization of arrhythmias in terms of ventricular rate | Characterization of arrhythmias in terms of ventricular rate | 18 months |
Episodes of hypoglycemia | Episodes of hypoglycemia \<3.9 mmol/L (defined as sensor glucose below 3.9 mmol/L for ≥ 15 min) | 18 months |
Time in range | Time in range (percentage of time and amount of time with sensor glucose in range 3.9-10.0 mmol/L) | 18 months |
Time below range (<3.9 mmol/L) | Time below range (percentage time and amount of time with sensor glucose \<3.9 mmol/L) | 18 months |
Time below range (<3.0 mmol/L) | Time below range (percentage of time and amount of time with sensor glucose \<3.0 mmol/L) | 18 months |
Time above range (>10.0 mmol/L) | Time above range (percentage of time and amount of time with sensor glucose \>10.0 mmol/L) | 18 months |
Time above range (>13.9 mmol/L) | Time above range (percentage of time and amount of time with sensor glucose \>13.9 mmol/L) | 18 months |
Mean sensor glucose | Mean sensor glucose derived from continuous glucose monitoring | 18 months |
Glycemic variability | Glycemic variability (defined as coefficient of variation and standard deviation) derived from continuous glucose monitoring | 18 months |
Arrhythmia leading to the implantation of a cardiac implantable electronic device | Presence of any arrhythmia leading to the implantation of a cardiac implantable electronic device | 18 months |
Arrhythmia leading to a medical intervention | Presence of any arrhythmia leading to a medical intervention (defined as any change in prescribed medication) | 18 months |
Adverse events | Presence of adverse events, including procedure related adverse events | 18 months |
Sudden cardiac death | Sudden cardiac death | 18 months |
Cardiovascular death | Cardiovascular death | 18 months |
All-cause mortality | All-cause mortality | 18 months |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
Patients with diabetes:
- Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization
- Treated with glucose-lowering drugs at inclusion
- Receiving in-center maintenance hemodialysis for more than 3 months
- Age ≥ 18 years
Patients without diabetes:
- No known diagnosis of diabetes
- No previous treatment with glucose-lowering drugs
- HbA1c < 48 mmol/mol at screening
- Receiving in-center maintenance hemodialysis for more than 3 months
- Age ≥ 18 years
For both groups:
- Cardiac pacemaker or implantable cardioverter defibrillator (ICD)
- Known permanent (chronic) atrial fibrillation
- History of sustained (> 30 seconds) ventricular tachycardia (more than 200 bpm) or ventricular fibrillation (note that ventricular premature beats is not considered an exclusion criterion)
- Known cardiac ion-channel disease (such as Long QT syndrome and Brugada syndrome)
- Not suitable for implantation (left-sided dialysis catheter or other condition expected to interfere with implantation)
- Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction
- Inability to give written informed consent
Rigshospitalet, Denmark- 🏥Herlev Hospital
연구 책임자
Bo Feldt-Rasmussen, 책임연구자, Professor, Rigshospitalet, Denmark
연락처 정보가 없습니다.
4 1개국에 임상시험 장소
Department of Nephrology, Rigshospitalet, Copenhagen, 2100, Denmark
Department of Nephrology, Herlev Hospital, Herlev, 2730, Denmark
Department of Nephrology, North Zealand Hospital, Hillerød, Denmark
Department of Nephrology, Holbæk Sygehus, Holbæk, 4300, Denmark