Diabetic Autonomic Neuropathy and Left Ventricular Function

NCT ID: NCT05713396

Last Updated: 2023-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2022-06-01

Brief Summary

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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

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quinapril (Q)

Patients receiving Quinapril

Group Type EXPERIMENTAL

Quinapril

Intervention Type DRUG

Per os

Losartan (L)

Patients receiving Losartan

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

Per os

Quinapril + Losartan (Q+L)

Patients receiving both Quinapril and Losartan

Group Type EXPERIMENTAL

Quinapril + Losartan

Intervention Type DRUG

Per os

Interventions

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Quinapril

Per os

Intervention Type DRUG

Losartan

Per os

Intervention Type DRUG

Quinapril + Losartan

Per os

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AHEPA University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthaios Didagelos

Consultant Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Triantafillos Didangelos, Professor

Role: PRINCIPAL_INVESTIGATOR

AHEPA University Hospital, Thessaloniki, Greece

Locations

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

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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72405

Identifier Type: -

Identifier Source: org_study_id

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