Diabetic Autonomic Neuropathy and Left Ventricular Function

Phase 4

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Quinapril + Losartan; Drug: Quinapril; Drug: Losartan

• Registration Number: NCT05713396
• Lead Sponsor: AHEPA University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-06-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Last Update Submitted: 2023-01-27
• Study First Posted: 2023-02-06
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quinapril + Losartan (Q+L)	Quinapril + Losartan	Patients receiving both Quinapril and Losartan
Quinapril (Q)	Quinapril	Patients receiving Quinapril
Losartan (L)	Losartan	Patients receiving Losartan

Primary Outcome Measures

Name	Time	Method
MCR	4 years	Mean Circular Resultant
AV	4 years	Atrial contribution to ventricular filling

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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