Diabetic Autonomic Neuropathy and Left Ventricular Function
NCT ID: NCT05713396
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2017-01-01
2022-06-01
Brief Summary
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Patients-methods: Fifty-nine patients with definite DAN \[2 or more of the 4 Cardiovascular Reflex Tests (CRTs) were abnormal\] were studied for 4 years. Patients were randomly allocated in 3 groups receiving A, 20 mg Q, B, 100 mg L and C, 20 mg Q +100 mg L respectively. CRTs analyzed with Mean Circular Resultant (MCR), Valsalva index, 30:15 ratio and postural hypotension. LV function was investigated with radionuclide ventriculography (RNV) at rest. Ejection fraction was used to assess LV systolic function, while peak filling rate, first third filling fraction, and atrial contribution to ventricular filling were used to investigate LV diastolic function. CRTs and RNV were performed at baseline and after 4 years.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Quinapril (Q)
Patients receiving Quinapril
Quinapril
Per os
Losartan (L)
Patients receiving Losartan
Losartan
Per os
Quinapril + Losartan (Q+L)
Patients receiving both Quinapril and Losartan
Quinapril + Losartan
Per os
Interventions
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Quinapril
Per os
Losartan
Per os
Quinapril + Losartan
Per os
Eligibility Criteria
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Inclusion Criteria
2. Diabetes mellitus
3. Diabetic autonomic neuropathy
Exclusion Criteria
2. Arterial hypertension
3. Heart failure with reduced ejection fraction LVEF\<40%
4. Any contraindication to undergo radionuclide ventriculography
18 Years
ALL
No
Sponsors
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AHEPA University Hospital
OTHER
Responsible Party
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Matthaios Didagelos
Consultant Cardiologist
Principal Investigators
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Triantafillos Didangelos, Professor
Role: PRINCIPAL_INVESTIGATOR
AHEPA University Hospital, Thessaloniki, Greece
Locations
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Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital
Thessaloniki, , Greece
Countries
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Other Identifiers
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72405
Identifier Type: -
Identifier Source: org_study_id
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