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Purpose: To investigate the effect of Quinapril (Q) or Losartan (L) or their combination on definite Diabetic Autonomic Neuropathy (DAN) and left ventricular systolic and diastolic function (LVF) over a period of 4 years.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quinapril (Q) | Experimental | Patients receiving Quinapril |
|
| Losartan (L) | Experimental | Patients receiving Losartan |
|
| Quinapril + Losartan (Q+L) | Experimental | Patients receiving both Quinapril and Losartan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quinapril | Drug | Per os |
| |
| Losartan |
| Measure | Description | Time Frame |
|---|---|---|
| MCR | Mean Circular Resultant | 4 years |
| AV | Atrial contribution to ventricular filling | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| E/I Index | Expiration/Inspiration Index | 4 years |
| SD | Standard Deviation | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Triantafillos Didangelos, Professor | AHEPA University Hospital, Thessaloniki, Greece | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital | Thessaloniki | 54636 | Greece |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077583 | Quinapril |
| D019808 | Losartan |
| ID | Term |
|---|---|
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
Per os |
|
| Quinapril + Losartan | Drug | Per os |
|
| Valsalva Index | Valsalva Maneuver | 4 years |
| 30:15 Index | Variation of R-R interval during postural change | 4 years |
| Postural hypotension | Variation of systolic blood pressure during postural change (standing) | 4 years |
| EF | Left ventricular ejection fraction | 4 years |
| PER | Peak emptying rate | 4 years |
| PFR | Peak filling rate Peak filling rate | 4 years |
| 1/3 FF | Filling fraction during the first third of the diastole | 4 years |
| TPF/FT | Time to peak filling time/filling time | 4 years |
| D006571 | Heterocyclic Compounds |
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D013777 | Tetrazoles |