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Completed

NCT Number: NCT05713396

Diabetic Autonomic Neuropathy and Left Ventricular Function

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Thessaloniki, 54636, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years old
  • Diabetes mellitus
  • Diabetic autonomic neuropathy

Exclusion criteria

  • Coronary artery disease
  • Arterial hypertension
  • Heart failure with reduced ejection fraction LVEF<40%
  • Any contraindication to undergo radionuclide ventriculography

Treatment and study plan

Quinapril

Drug

Per os

Losartan

Drug

Per os

Quinapril + Losartan

Drug

Per os

Primary outcomes

  1. MCR

    Time frame: 4 years

    Mean Circular Resultant

  2. AV

    Time frame: 4 years

    Atrial contribution to ventricular filling

Secondary outcomes

  1. E/I Index

    Time frame: 4 years

    Expiration/Inspiration Index

  2. SD

    Time frame: 4 years

    Standard Deviation

  3. Valsalva Index

    Time frame: 4 years

    Valsalva Maneuver

  4. 30:15 Index

    Time frame: 4 years

    Variation of R-R interval during postural change

  5. Postural hypotension

    Time frame: 4 years

    Variation of systolic blood pressure during postural change (standing)

  6. EF

    Time frame: 4 years

    Left ventricular ejection fraction

  7. PER

    Time frame: 4 years

    Peak emptying rate

  8. PFR

    Time frame: 4 years

    Peak filling rate Peak filling rate

  9. 1/3 FF

    Time frame: 4 years

    Filling fraction during the first third of the diastole

  10. TPF/FT

    Time frame: 4 years

    Time to peak filling time/filling time

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Registry information

Official study 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.

Acronym: DANEL

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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