Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-28 @ 2:04 PM
Study NCT ID:
NCT04841304
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-18
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Arrhythmia in Patients with End-Stage Renal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in arrhythmias between patients with diabetes and patients without diabetes', 'timeFrame': '18 months', 'description': 'Difference in arrhythmias between patients with diabetes and patients without diabetes'}, {'measure': 'Arrhythmias during hypoglycemia compared to euglycemia/hyperglycemia', 'timeFrame': '18 months', 'description': 'Arrhythmias during hypoglycemia compared to euglycemia and hyperglycemia'}, {'measure': 'The temporal distribution of arrhythmias in relation to hypoglycemic events', 'timeFrame': '18 months', 'description': 'Arrhythmic events one hour prior to hypoglycemia, during hypoglycemia and one hour post hypoglycemia'}, {'measure': 'Difference in glycemic characteristics between patients with and without diabetes', 'timeFrame': '18 months', 'description': 'Difference in glycemic characteristics between patients with and without diabetes'}, {'measure': 'Correlation between pre-dialysis blood samples and arrhythmias', 'timeFrame': '18 months', 'description': 'Correlation between pre-dialysis blood samples and arrhythmias'}, {'measure': 'Correlation between dialysis parameters and arrhythmias', 'timeFrame': '18 months', 'description': 'Correlation between dialysis parameters (dialysate electrolyte concentrations and temperature) and arrhythmias'}, {'measure': 'Correlation between a decline in systolic blood pressure during dialysis and arrythmias', 'timeFrame': '18 months', 'description': 'Correlation between a decline in systolic blood pressure ≥20 mmHg during a dialysis session and arrythmias'}, {'measure': 'Correlation between ultrafiltration rate and arrhythmias', 'timeFrame': '18 months', 'description': 'Correlation between ultrafiltration rate and arrhythmias'}, {'measure': 'The temporal distribution of arrhythmias in relation to dialysis sessions', 'timeFrame': '18 months', 'description': 'Arrhythmic events eight hours prior to dialysis, during dialysis, eight hours post dialysis, and in the interval between dialysis sessions'}, {'measure': 'Correlation between baseline clinical variables and arrhythmias', 'timeFrame': '18 months', 'description': 'Correlation between baseline clinical variables (baseline demographic and comorbidity characteristics) and arrhythmias'}, {'measure': 'Correlation between baseline residual diuresis and arrhythmias', 'timeFrame': '18 months', 'description': 'Correlation between baseline residual diuresis and arrhythmias'}, {'measure': 'Correlation between baseline electrocardiographic and echocardiographic markers and arrhythmias', 'timeFrame': '18 months', 'description': 'Correlation between baseline electrocardiographic (assessed by 12-lead ECG) and echocardiographic markers (assessed by transthoracic echo) and arrhythmias'}, {'measure': 'Correlation between heart rate variability, daytime and nighttime heart rate, physical activity, and risk of arrhythmias', 'timeFrame': '18 months', 'description': 'Correlation between heart rate variability, daytime and nighttime heart rate, physical activity, and risk of arrhythmias'}], 'primaryOutcomes': [{'measure': 'Clinically significant arrhythmias', 'timeFrame': '18 months', 'description': 'Presence of one of the items in the combined endpoint of clinically significant arrhythmias defined as:\n\n* Significant bradyarrhythmia (pause \\> 3 seconds or ≥ 4 beats at rate \\< 30 beats/min)\n* Ventricular tachycardia (lasting ≥ 16 beats at rate ≥ 150 beats/min)\n* Ventricular fibrillation'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation', 'timeFrame': '18 months', 'description': 'Presence of atrial fibrillation (lasting ≥ 2 minutes)'}, {'measure': 'Supraventricular tachycardia other than atrial fibrillation', 'timeFrame': '18 months', 'description': 'Presence of supraventricular tachycardia other than atrial fibrillation (lasting ≥ 16 beats at rate ≥ 150 beats/min)'}, {'measure': 'Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively', 'timeFrame': '18 months', 'description': 'Time to clinically significant arrhythmias, atrial fibrillation, or supraventricular tachycardia, respectively'}, {'measure': 'Characterization of arrhythmias in terms of onset', 'timeFrame': '18 months', 'description': 'Characterization of arrhythmias in terms of onset'}, {'measure': 'Characterization of arrhythmias in terms of duration', 'timeFrame': '18 months', 'description': 'Characterization of arrhythmias in terms of duration'}, {'measure': 'Characterization of arrhythmias in terms of ventricular rate', 'timeFrame': '18 months', 'description': 'Characterization of arrhythmias in terms of ventricular rate'}, {'measure': 'Episodes of hypoglycemia', 'timeFrame': '18 months', 'description': 'Episodes of hypoglycemia \\<3.9 mmol/L (defined as sensor glucose below 3.9 mmol/L for ≥ 15 min)'}, {'measure': 'Time in range', 'timeFrame': '18 months', 'description': 'Time in range (percentage of time and amount of time with sensor glucose in range 3.9-10.0 mmol/L)'}, {'measure': 'Time below range (<3.9 mmol/L)', 'timeFrame': '18 months', 'description': 'Time below range (percentage time and amount of time with sensor glucose \\<3.9 mmol/L)'}, {'measure': 'Time below range (<3.0 mmol/L)', 'timeFrame': '18 months', 'description': 'Time below range (percentage of time and amount of time with sensor glucose \\<3.0 mmol/L)'}, {'measure': 'Time above range (>10.0 mmol/L)', 'timeFrame': '18 months', 'description': 'Time above range (percentage of time and amount of time with sensor glucose \\>10.0 mmol/L)'}, {'measure': 'Time above range (>13.9 mmol/L)', 'timeFrame': '18 months', 'description': 'Time above range (percentage of time and amount of time with sensor glucose \\>13.9 mmol/L)'}, {'measure': 'Mean sensor glucose', 'timeFrame': '18 months', 'description': 'Mean sensor glucose derived from continuous glucose monitoring'}, {'measure': 'Glycemic variability', 'timeFrame': '18 months', 'description': 'Glycemic variability (defined as coefficient of variation and standard deviation) derived from continuous glucose monitoring'}, {'measure': 'Arrhythmia leading to the implantation of a cardiac implantable electronic device', 'timeFrame': '18 months', 'description': 'Presence of any arrhythmia leading to the implantation of a cardiac implantable electronic device'}, {'measure': 'Arrhythmia leading to a medical intervention', 'timeFrame': '18 months', 'description': 'Presence of any arrhythmia leading to a medical intervention (defined as any change in prescribed medication)'}, {'measure': 'Adverse events', 'timeFrame': '18 months', 'description': 'Presence of adverse events, including procedure related adverse events'}, {'measure': 'Sudden cardiac death', 'timeFrame': '18 months', 'description': 'Sudden cardiac death'}, {'measure': 'Cardiovascular death', 'timeFrame': '18 months', 'description': 'Cardiovascular death'}, {'measure': 'All-cause mortality', 'timeFrame': '18 months', 'description': 'All-cause mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease on Dialysis', 'Cardiac Arrhythmia', 'Diabetes Mellitus', 'Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '40019498', 'type': 'DERIVED', 'citation': 'Kofod DH, Diederichsen SZ, Bomholt T, Andersen MO, Andersen A, Mannheimer E, Rix M, Liem YS, Lindhard K, Hansen HP, Rydahl C, Lindhardt M, Brosen J, Schandorff K, Lange T, Norgaard K, Almdal TP, Svendsen JH, Feldt-Rasmussen B, Hornum M. Cardiac arrhythmia and hypoglycaemia among individuals with and without diabetes receiving haemodialysis (the CADDY study): a Danish multicentre cohort study. Diabetologia. 2025 Jun;68(6):1126-1139. doi: 10.1007/s00125-025-06388-5. Epub 2025 Feb 28.'}, {'pmid': '37890966', 'type': 'DERIVED', 'citation': 'Kofod DH, Diederichsen SZ, Bomholt T, Orbaek Andersen M, Rix M, Liem Y, Lindhard K, Post Hansen H, Rydahl C, Lindhardt M, Schandorff K, Lange T, Norgaard K, Almdal TP, Svendsen JH, Feldt-Rasmussen B, Hornum M. Cardiac arrhythmia and hypoglycaemia in patients receiving haemodialysis with and without diabetes (the CADDY study): protocol for a Danish multicentre cohort study. BMJ Open. 2023 Oct 27;13(10):e077063. doi: 10.1136/bmjopen-2023-077063.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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 patients without diabetes.\n\nData collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.\n\nAfter the initial 18-month follow-up, heart rhythm monitoring will continue until the ILR battery runs out for those participants who wish to continue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '70 subjects receiving chronic hemodialysis therapy:\n\n* 35 subjects with diabetes\n* 35 subjects without diabetes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with diabetes:\n\n* Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization\n* Treated with glucose-lowering drugs at inclusion\n* Receiving in-center maintenance hemodialysis for more than 3 months\n* Age ≥ 18 years\n\nPatients without diabetes:\n\n* No known diagnosis of diabetes\n* No previous treatment with glucose-lowering drugs\n* HbA1c \\< 48 mmol/mol at screening\n* Receiving in-center maintenance hemodialysis for more than 3 months\n* Age ≥ 18 years\n\nExclusion Criteria:\n\nFor both groups:\n\n* Cardiac pacemaker or implantable cardioverter defibrillator (ICD)\n* Known permanent (chronic) atrial fibrillation\n* 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)\n* Known cardiac ion-channel disease (such as Long QT syndrome and Brugada syndrome)\n* Not suitable for implantation (left-sided dialysis catheter or other condition expected to interfere with implantation)\n* Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction\n* Inability to give written informed consent'}, 'identificationModule': {'nctId': 'NCT04841304', 'acronym': 'CADDY', 'briefTitle': 'Cardiac Arrhythmia in Patients with End-Stage Renal Disease', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Cardiac Arrhythmia in Patients with End-Stage Renal Disease', 'orgStudyIdInfo': {'id': 'H-20069767'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving hemodialysis with diabetes', 'description': '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', 'interventionNames': ['Device: Loop recorder (Reveal LINQ, Medtronic)', 'Device: Continuous Glucose Measurement (G6, Dexcom)']}, {'label': 'Patients receiving hemodialysis without diabetes', 'description': 'Patients receiving chronic hemodialysis without diabetes (no known diagnosis of diabetes, and HbA1c \\< 48 mmol/mol at inclusion)', 'interventionNames': ['Device: Loop recorder (Reveal LINQ, Medtronic)', 'Device: Continuous Glucose Measurement (G6, Dexcom)']}], 'interventions': [{'name': 'Loop recorder (Reveal LINQ, Medtronic)', 'type': 'DEVICE', 'description': 'Implantation of a loop-recorder', 'armGroupLabels': ['Patients receiving hemodialysis with diabetes', 'Patients receiving hemodialysis without diabetes']}, {'name': 'Continuous Glucose Measurement (G6, Dexcom)', 'type': 'DEVICE', 'description': 'Monitoring with a continuous glucose monitor', 'armGroupLabels': ['Patients receiving hemodialysis with diabetes', 'Patients receiving hemodialysis without diabetes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Nephrology, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Nephrology, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Department of Nephrology, North Zealand Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '4300', 'city': 'Holbæk', 'country': 'Denmark', 'facility': 'Department of Nephrology, Holbæk Sygehus', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herlev Hospital', 'class': 'OTHER'}, {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, {'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Hillerod Hospital, Denmark', 'class': 'OTHER'}, {'name': 'Holbaek Sygehus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bo Feldt-Rasmussen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}