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Diabetic Autonomic Neuropathy and Left Ventricular Function (DANEL)

Primary Purpose

Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Quinapril
Losartan
Quinapril + Losartan
Sponsored by
AHEPA University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Quinapril (Q)

Losartan (L)

Quinapril + Losartan (Q+L)

Arm Description

Patients receiving Quinapril

Patients receiving Losartan

Patients receiving both Quinapril and Losartan

Outcomes

Primary Outcome Measures

MCR
Mean Circular Resultant
AV
Atrial contribution to ventricular filling

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2023
Last Updated
January 27, 2023
Sponsor
AHEPA University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05713396
Brief Title
Diabetic Autonomic Neuropathy and Left Ventricular Function
Acronym
DANEL
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AHEPA University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quinapril (Q)
Arm Type
Experimental
Arm Description
Patients receiving Quinapril
Arm Title
Losartan (L)
Arm Type
Experimental
Arm Description
Patients receiving Losartan
Arm Title
Quinapril + Losartan (Q+L)
Arm Type
Experimental
Arm Description
Patients receiving both Quinapril and Losartan
Intervention Type
Drug
Intervention Name(s)
Quinapril
Intervention Description
Per os
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Description
Per os
Intervention Type
Drug
Intervention Name(s)
Quinapril + Losartan
Intervention Description
Per os
Primary Outcome Measure Information:
Title
MCR
Description
Mean Circular Resultant
Time Frame
4 years
Title
AV
Description
Atrial contribution to ventricular filling
Time Frame
4 years
Secondary Outcome Measure Information:
Title
E/I Index
Description
Expiration/Inspiration Index
Time Frame
4 years
Title
SD
Description
Standard Deviation
Time Frame
4 years
Title
Valsalva Index
Description
Valsalva Maneuver
Time Frame
4 years
Title
30:15 Index
Description
Variation of R-R interval during postural change
Time Frame
4 years
Title
Postural hypotension
Description
Variation of systolic blood pressure during postural change (standing)
Time Frame
4 years
Title
EF
Description
Left ventricular ejection fraction
Time Frame
4 years
Title
PER
Description
Peak emptying rate
Time Frame
4 years
Title
PFR
Description
Peak filling rate Peak filling rate
Time Frame
4 years
Title
1/3 FF
Description
Filling fraction during the first third of the diastole
Time Frame
4 years
Title
TPF/FT
Description
Time to peak filling time/filling time
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Triantafillos Didangelos, Professor
Organizational Affiliation
AHEPA University Hospital, Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital
City
Thessaloníki
ZIP/Postal Code
54636
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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Diabetic Autonomic Neuropathy and Left Ventricular Function

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