drugset / Trial / NCT05713396

Diabetic Autonomic Neuropathy and Left Ventricular Function

NCT05713396

Phase 4 Completed 59 enrolled AHEPA University Hospital
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-01-01
Primary completion
2022-06-01
Completion
2022-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Losartan Other / unclassified 100 mg Oral
Subject Quinapril Small molecule 20 mg Oral

Indications