Diabetic Autonomic Neuropathy and Left Ventricular Function (DANEL)

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: Diabetes Mellitus
• Intervention / Treatment: Drug: Quinapril; Drug: Losartan; Drug: Quinapril + Losartan

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	Mean Circular Resultant	4 years
AV	Atrial contribution to ventricular filling	4 years

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Losartan; Quinapril
• 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