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.
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AHEPA University Hospital
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- MCR
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Quinapril (Q)
Patients receiving Quinapril
Intervention: Quinapril (Drug)
Losartan (L)
Patients receiving Losartan
Intervention: Losartan (Drug)
Quinapril + Losartan (Q+L)
Patients receiving both Quinapril and Losartan
Intervention: Quinapril + Losartan (Drug)
Outcomes
Primary Outcomes
MCR
Time Frame: 4 years
Mean Circular Resultant
AV
Time Frame: 4 years
Atrial contribution to ventricular filling
Secondary Outcomes
- 30:15 Index(4 years)
- Valsalva Index(4 years)
- Postural hypotension(4 years)
- SD(4 years)
- EF(4 years)
- TPF/FT(4 years)
- E/I Index(4 years)
- PER(4 years)
- 1/3 FF(4 years)
- PFR(4 years)
Investigators
Matthaios Didagelos
Consultant Cardiologist
AHEPA University Hospital