Diabetic Autonomic Neuropathy and Left Ventricular Function

Study Overview
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Brief Summary
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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.

Official Title
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Long - Term Effect of Quinapril or Losartan or Their Combination on Diabetic Autonomic Neuropathy and Left Ventricular Function Over a Period of 4 Years. A Radionuclide Ventriculography Study.

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Quinapril
* Drug: Losartan
* Drug: Quinapril + Losartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old Diabetes mellitus Diabetic autonomic neuropathy Exclusion Criteria: Coronary artery disease Arterial hypertension Heart failure with reduced ejection fraction LVEF<40% Any contraindication to undergo radionuclide ventriculography

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quinapril (Q)<br>Patients receiving Quinapril | Drug: Quinapril<br>* Per os<br>|
| Experimental: Losartan (L)<br>Patients receiving Losartan | Drug: Losartan<br>* Per os<br>|
| Experimental: Quinapril + Losartan (Q+L)<br>Patients receiving both Quinapril and Losartan | Drug: Quinapril + Losartan<br>* Per os<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MCR | Mean Circular Resultant | 4 years | 
| AV | Atrial contribution to ventricular filling | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| E/I Index | Expiration/Inspiration Index | 4 years | 
| SD | Standard Deviation | 4 years | 
| 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 |