Diabetic Autonomic Neuropathy and Left Ventricular Function

Diabetes Mellitus Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05713396
• Other study ID #: 72405
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: January 2023
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies

Intervention

Drug:
• Quinapril
Per os
• Losartan
Per os
• Quinapril + Losartan
Per os

Locations

Country	Name	City	State
Greece	Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MCR	Mean Circular Resultant	4 years
Primary	AV	Atrial contribution to ventricular filling	4 years
Secondary	E/I Index	Expiration/Inspiration Index	4 years
Secondary	SD	Standard Deviation	4 years
Secondary	Valsalva Index	Valsalva Maneuver	4 years
Secondary	30:15 Index	Variation of R-R interval during postural change	4 years
Secondary	Postural hypotension	Variation of systolic blood pressure during postural change (standing)	4 years
Secondary	EF	Left ventricular ejection fraction	4 years
Secondary	PER	Peak emptying rate	4 years
Secondary	PFR	Peak filling rate Peak filling rate	4 years
Secondary	1/3 FF	Filling fraction during the first third of the diastole	4 years
Secondary	TPF/FT	Time to peak filling time/filling time	4 years