Diabetic Autonomic Neuropathy and Left Ventricular Function (DANEL)

January 27, 2023 updated by: Matthaios Didagelos, AHEPA University Hospital

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloníki, Greece, 54636
        • Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. >18 years old
  2. Diabetes mellitus
  3. Diabetic autonomic neuropathy

Exclusion Criteria:

  1. Coronary artery disease
  2. Arterial hypertension
  3. Heart failure with reduced ejection fraction LVEF<40%
  4. Any contraindication to undergo radionuclide ventriculography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Quinapril (Q)
Patients receiving Quinapril
Drug: Quinapril
Per os
EXPERIMENTAL: Losartan (L)
Patients receiving Losartan
Drug: Losartan
Per os
EXPERIMENTAL: Quinapril + Losartan (Q+L)
Patients receiving both Quinapril and Losartan
Drug: Quinapril + Losartan
Per os

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
E/I Index
Time Frame: 4 years
Expiration/Inspiration Index
4 years
SD
Time Frame: 4 years
Standard Deviation
4 years
Valsalva Index
Time Frame: 4 years
Valsalva Maneuver
4 years
30:15 Index
Time Frame: 4 years
Variation of R-R interval during postural change
4 years
Postural hypotension
Time Frame: 4 years
Variation of systolic blood pressure during postural change (standing)
4 years
EF
Time Frame: 4 years
Left ventricular ejection fraction
4 years
PER
Time Frame: 4 years
Peak emptying rate
4 years
PFR
Time Frame: 4 years
Peak filling rate Peak filling rate
4 years
1/3 FF
Time Frame: 4 years
Filling fraction during the first third of the diastole
4 years
TPF/FT
Time Frame: 4 years
Time to peak filling time/filling time
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Investigators

  • Principal Investigator: Triantafillos Didangelos, Professor, AHEPA University Hospital, Thessaloniki, Greece

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

June 1, 2022

Study Registration Dates

First Submitted

January 27, 2023

First Submitted That Met QC Criteria

January 27, 2023

First Posted (ACTUAL)

February 6, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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