DANEL: Diabetic Autonomic Neuropathy and Left Ventricular Function

• Sponsor: AHEPA University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05713396
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 3
• Actual Duration (Months): 65
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Quinapril; Drug: Losartan; Drug: Quinapril + Losartan	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jun 1, 2022
• Actual Study Completion Date: Jun 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. MCR [4 years]

   Mean Circular Resultant

2. AV [4 years]

   Atrial contribution to ventricular filling

Secondary Outcome Measures

1. E/I Index [4 years]

   Expiration/Inspiration Index

2. SD [4 years]

   Standard Deviation

3. Valsalva Index [4 years]

   Valsalva Maneuver

4. 30:15 Index [4 years]

   Variation of R-R interval during postural change

5. Postural hypotension [4 years]

   Variation of systolic blood pressure during postural change (standing)

6. EF [4 years]

   Left ventricular ejection fraction

7. PER [4 years]

   Peak emptying rate

8. PFR [4 years]

   Peak filling rate Peak filling rate

9. 1/3 FF [4 years]

   Filling fraction during the first third of the diastole

10. TPF/FT [4 years]

    Time to peak filling time/filling time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital	Thessaloníki		Greece	54636

Sponsors and Collaborators

• AHEPA University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthaios Didagelos, Consultant Cardiologist, AHEPA University Hospital
• ClinicalTrials.gov Identifier: NCT05713396
• Other Study ID Numbers: 72405
• First Posted: Feb 6, 2023
• Last Update Posted: Feb 6, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetic Neuropathies; Losartan; Quinapril

Study Results

No Results Posted as of Feb 6, 2023