Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 11:23 AM
Study NCT ID:
NCT05059769
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2020-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Ambulatory Arterial Stiffness Index and Left Ventricular Diastolic Function in Patients With HFpEF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2020-10-10', 'studyFirstSubmitQcDate': '2021-09-26', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Left ventricular diastolic function', 'timeFrame': '1 day On admission', 'description': "the ratio of mitral peak velocity of early filling to early diastolic mitral annular velocity(E/e')"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. There is no report on whether AASI is associated with left ventricular diastolic dysfunction in patients with HFpEF.', 'detailedDescription': 'Heart failure with preserved ejection fraction (HFpEF) is related to various complications, such as hypertension, obesity and arteriosclerosis. Ambulatory arterial stiffness index (AASI) is associated with arteriosclerosis and hypertension. AASI is especially associated with left ventricular diastolic dysfunction in patients with hypertension. Patients with HFpEF have obvious left ventricular diastolic insufficiency. However, there is still no research investigating the the relationship between AASI and left ventricular diastolic dysfunction in patients with HFpEF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Heart failure patients with preserved ejection fraction (HFpEF)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult aged \\>=18years old; Diagnosed with HFpEF.\n\nExclusion Criteria:\n\nLVEF less than 45% at any time; Severe liver failure; Other causes of shortness of breath, such as severe pulmonary disease or severe Severe valvular disease of the left heart; Chronically bedridden or incapacitated; Age \\<18 years old.'}, 'identificationModule': {'nctId': 'NCT05059769', 'briefTitle': 'Relationship Between Ambulatory Arterial Stiffness Index and Left Ventricular Diastolic Function in Patients With HFpEF', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'Relationship Between Ambulatory Arterial Stiffness Index and Left Ventricular Diastolic Function in Patients With HFpEF', 'orgStudyIdInfo': {'id': '2020-09-21'}}, 'contactsLocationsModule': {'locations': [{'zip': '400042', 'city': 'Chongqing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dongying Zhang', 'role': 'CONTACT', 'email': 'zdy.chris@qq.com', 'phone': '+8613608398395'}], 'facility': 'The first affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Zhang Dongying', 'role': 'CONTACT', 'email': 'zdy.chris@qq.com', 'phone': '+8613608398395'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongying Zhang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Dongying Zhang', 'investigatorAffiliation': 'Chongqing Medical University'}}}}