Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:59 AM
Study NCT ID:
NCT07086560
Status:
RECRUITING
Last Update Posted:
2025-08-03
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PERceptions of Diltiazem Versus ADEnosine for Treatment of Supraventricular Tachycardia in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D004110', 'term': 'Diltiazem'}], 'ancestors': [{'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D001552', 'term': 'Benzazepines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction with SVT treatment', 'timeFrame': 'Primary outcome will be assessed during ED visit', 'description': 'Patient satisfaction with treatment will be assessed using a Likert scale questionnaire of 1-5. Participants will indicate their satisfaction with treatment by indicating a score of 1-5, 1 being "not at all satisfied" and 5 being "extremely satisfied".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diltiazem', 'adenosine', 'emergency medicine', 'supraventricular tachycardia'], 'conditions': ['Supraventricular Tachycardia (SVT)']}, 'descriptionModule': {'briefSummary': 'Supraventricular tachycardia (SVT) is a dysrhythmia characterized rapid heart rate, typically with rapid onset. SVT accounts for over 50,000 emergency department visits per year. Of patients with regular, narrow-complex SVT, the mainstay of therapy includes adenosine and diltiazem. Adenosine is recommend by American and European guidelines as first-line therapy, however adenosine carries unique side effects that are potentially distressing to patients, including: "feeling of impending death or doom", flushing, anxiety, shortness of breath, and chest discomfort. Diltiazem does not carry this side effect profile, but has typically been reserved as second-line treatment due to side effects of low blood pressure associated with this class of medications. Diltiazem and adenosine have not been well studied head-to-head to compare safety and efficacy of their treatment for SVT. The purpose of this study is to evaluate safety and efficacy of adenosine and diltiazem for SVT in the ED (as completed through chart review of specific patient-level outcomes) and capture patient and clinician perspectives of medication satisfaction (through administration of questionnaires).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥18 years of age) treated for SVT in the ED. The investigators will screen a convenience sample of adult patients presenting with stable SVT in the ED for study eligibility while study investigators (most often emergency medicine clinical pharmacists) are available to enroll participants and administer study questionnaires.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ED encounter for acute SVT\n2. Age \\>/= 18 years\n3. Receipt of IV adenosine and/or IV diltiazem for SVT in the ED or prehospital setting\n\nExclusion Criteria:\n\n1. Neurologic status precluding survey participation due to medical instability\n2. Pregnant\n3. Incarcerated\n4. Non-English speaking'}, 'identificationModule': {'nctId': 'NCT07086560', 'acronym': 'PERVADE-ED', 'briefTitle': 'PERceptions of Diltiazem Versus ADEnosine for Treatment of Supraventricular Tachycardia in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'PERceptions of Diltiazem Versus ADEnosine for Treatment of Supraventricular Tachycardia in the Emergency Department: PERVADE-ED Study', 'orgStudyIdInfo': {'id': '202411431'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adenosine', 'interventionNames': ['Drug: IV adenosine']}, {'label': 'Diltiazem', 'interventionNames': ['Drug: IV diltiazem']}], 'interventions': [{'name': 'IV adenosine', 'type': 'DRUG', 'description': 'Patients will not be randomized to intervention but will be categorized based on the exposure of IV adenosine for treatment of SVT received prior to study enrollment', 'armGroupLabels': ['Adenosine']}, {'name': 'IV diltiazem', 'type': 'DRUG', 'description': 'Patients will not be randomized to intervention but will be categorized based on the exposure of IV diltiazem for treatment of SVT received prior to study enrollment', 'armGroupLabels': ['Diltiazem']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anne Zepeski', 'role': 'CONTACT', 'email': 'anne-zepeski@uiowa.edu', 'phone': '651-207-9357'}], 'facility': 'University of Iowa Health Care', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'centralContacts': [{'name': 'Anne Zepeski, PharmD', 'role': 'CONTACT', 'email': 'anne-zepeski@uiowa.edu', 'phone': '651-207-9357'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Iowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Anne E. Zepeski', 'investigatorAffiliation': 'University of Iowa'}}}}