Diabetes MellitusPhase 4DANELNCT05713396
Diabetic Autonomic Neuropathy and Left Ventricular Function
A Phase 4 study testing Quinapril, Losartan and Quinapril + Losartan in people with Diabetes Mellitus, run by AHEPA University Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Quinapril, Losartan and Quinapril + Losartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2017to 1 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years old
- Diabetes mellitus
- Diabetic autonomic neuropathy
Who cannot join
- Coronary artery disease
- Arterial hypertension
- Heart failure with reduced ejection fraction LVEF<40%
- Any contraindication to undergo radionuclide ventriculography
Trial locations and contacts
1 site in 1 country.
Greece1 site
Diabetes Center, 1st Propeudetic Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, "AHEPA'' Hospital
Thessaloniki, 54636
About this study
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.
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Quinapril, Losartan, Quinapril + Losartan
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuinaprilDrug
Per os
LosartanDrug
Per os
Quinapril + LosartanDrug
Per os
| Study group | Role | What they receive |
|---|---|---|
| Quinapril (Q) | Experimental | Patients receiving Quinapril Receives: Drug: Quinapril |
| Losartan (L) | Experimental | Patients receiving Losartan Receives: Drug: Losartan |
| Quinapril + Losartan (Q+L) | Experimental | Patients receiving both Quinapril and Losartan Receives: Drug: Quinapril + Losartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCR
Mean Circular Resultant
Measured: 4 years
AV
Atrial contribution to ventricular filling
Measured: 4 years
Secondary outcomes (10)
E/I Index
Expiration/Inspiration Index
Measured: 4 years
SD
Standard Deviation
Measured: 4 years
Valsalva Index
Valsalva Maneuver
Measured: 4 years
30:15 Index
Variation of R-R interval during postural change
Measured: 4 years
Postural hypotension
Variation of systolic blood pressure during postural change (standing)
Measured: 4 years
EF
Left ventricular ejection fraction
Measured: 4 years
PER
Peak emptying rate
Measured: 4 years
PFR
Peak filling rate Peak filling rate
Measured: 4 years
1/3 FF
Filling fraction during the first third of the diastole
Measured: 4 years
TPF/FT
Time to peak filling time/filling time
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Jan 2017
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHEPA University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthaios Didagelos, AHEPA University Hospital
- Investigators
- Triantafillos Didangelos, Professor, Principal investigator, AHEPA University Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713396
- Sponsor's protocol ID
- 72405
- Acronym
- DANEL
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05713396
- Acronym / sponsor ID
- DANEL / 72405
- Conditions
- Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- AHEPA University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quinapril (Q) | Experimental | Drug: QuinaprilPatients receiving Quinapril |
| Losartan (L) | Experimental | Drug: LosartanPatients receiving Losartan |
| Quinapril + Losartan (Q+L) | Experimental | Drug: Quinapril + LosartanPatients receiving both Quinapril and Losartan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old
- Diabetes mellitus
- Diabetic autonomic neuropathy
Key exclusion criteria (4 listed)
- Coronary artery disease
- Arterial hypertension
- Heart failure with reduced ejection fraction LVEF<40%
- Any contraindication to undergo radionuclide ventriculography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuinaprilPer os | Drug | Quinapril (Q) |
| LosartanPer os | Drug | Losartan (L) |
| Quinapril + LosartanPer os | Drug | Quinapril + Losartan (Q+L) |
Primary outcome
MCR
Time frame: 4 years
Mean Circular Resultant
AV
Time frame: 4 years
Atrial contribution to ventricular filling
10 secondary outcomes
E/I Index
Time frame: 4 years
SD
Time frame: 4 years
Valsalva Index
Time frame: 4 years
30:15 Index
Time frame: 4 years
Postural hypotension
Time frame: 4 years
EF
Time frame: 4 years
PER
Time frame: 4 years
PFR
Time frame: 4 years
1/3 FF
Time frame: 4 years
TPF/FT
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Triantafillos Didangelos, Professor principal investigator
AHEPA University Hospital, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quinapril, Losartan and Quinapril + Losartan in people with Diabetes Mellitus, run by AHEPA University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCR (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.