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Diabetic Autonomic Neuropathy and Left Ventricular Function

NCT05713396 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-02-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Quinapril

Per os

DRUG

Losartan

Per os

DRUG

Quinapril + Losartan

Per os

Sponsors & Collaborators

  • AHEPA University Hospital

    lead OTHER

Principal Investigators

  • Triantafillos Didangelos, Professor · AHEPA University Hospital, Thessaloniki, Greece

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05713396 on ClinicalTrials.gov