Endothelial DysfunctionRadialisNCT03488823
Flavonols and Endothelial Injury
A study testing with Flavanol and without Flavanol in people with Endothelial Dysfunction, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
Trial summary
With increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- with Flavanol and without Flavanol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 30 Apr 2018
- Phase
- Interventional
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planed catheterization, that has be done via Arteria radialis
Who cannot join
- acute infection (CRP>0.5 mg/dl)
- malignant diseases
- heart failure (NYHA III-IV)
- renal failure (GFR<60 ml/min)
- profoundly atrial fibrilation
- hypotension (≤100/60 mmHg)
- intolerance of nitroglycerin
Trial locations and contacts
1 site in 1 country.
Germany1 site
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Evaluation of Effects of Flavonols on Endothelial Function and Hyperplasia of Intima After Endothelium Injury During Transradial Catheter.
With increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. Recent studies suggest that flavanols may affect important endothelial regeneration response processes and possibly mediate long-term positive vascular effects. The aim of this study is to investigate age-dependent mechanisms of impaired endothelial regeneration and the influence of dietary flavanols on them. For this purpose, younger and old male patients, who are clinically indicated for elective transradial catheterization, will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols daily), or control drink. Administration of drinks is randomized and double-blind. The test drinks should be given one week before the elective catheter examination until 1 week later. The endothelial regeneration is to be investigated as endothelium-dependent vasodilation non-invasively in the area of the puncture site on the forearm and by means of biomarkers in the blood. The endothelial function of the Arteria radialis will be measured with Flow Mediated Dilation (FMD) before and 24 h after catheterization. One month after catheterization patients undergo ultrasound examination of arteria radialis, to include structural vessel wall changes as intimal media thickness.
- Conditions
- Endothelial Dysfunction
- Being tested
- with Flavanol, without Flavanol
- Keywords
- Endothelial Function, Flavonols, Intima Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with FlavanolDietary supplement
Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.
without FlavanolDietary supplement
Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.
| Study group | Role | What they receive |
|---|---|---|
| Young with Flavanol | Experimental | Young patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols). Receives: Dietary Supplement: with Flavanol |
| Young without Flavanol | Placebo comparator | Young patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols . Receives: Dietary Supplement: without Flavanol |
| Old with Flavanol | Experimental | Old patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols). Receives: Dietary Supplement: with Flavanol |
| Old without Flavanol | Placebo comparator | Young patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols. Receives: Dietary Supplement: without Flavanol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of Endothelial Function of Arteria radialis
Change from Baseline Endothelial Function of Arteria radialis measured with Flow Mediated Dilation (FMD) after catheterization
Measured: week 2
Secondary outcomes (1)
Degree of intimal Injury after Catheterization
Intimal Injury will be measured as intima media thickness with duplex sonography 1 month after catheterization
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Nov 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Roberto Sansone, MD, Principal investigator, Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488823
- Sponsor's protocol ID
- 12-012
- Acronym
- Radialis
- Status last verified
- May 2018
- First submitted
- 15 Feb 2018
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effects of Flavonols on Endothelial Function and Hyperplasia of Intima After Endothelium Injury During Transradial Catheter.
- ClinicalTrials.gov ID
- NCT03488823
- Acronym / sponsor ID
- Radialis / 12-012
- Conditions
- Endothelial Dysfunction
- Keywords
- Endothelial Function, Flavonols, Intima Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Klinik für Kardiologie, Pneumologie und AngiologieUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Apr 2018 (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.
With increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. Dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. Recent studies suggest that flavanols may affect important endothelial regeneration response processes and possibly mediate long-term positive vascular effects. The aim of this study is to investigate age-dependent mechanisms of impaired endothelial regeneration and the influence of dietary flavanols on them. For this purpose, younger and old male patients, who are clinically indicated for elective transradial catheterization, will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols daily), or control drink. Administration of drinks is randomized and double-blind. The test drinks should be given one week before the elective catheter examination until 1 week later. The endothelial regeneration is to be investigated as endothelium-dependent vasodilation non-invasively in the area of the puncture site on the forearm and by means of biomarkers in the blood. The endothelial function of the Arteria radialis will be measured with Flow Mediated Dilation (FMD) before and 24 h after catheterization. One month after catheterization patients undergo ultrasound examination of arteria radialis, to include structural vessel wall changes as intimal media thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young with Flavanol | Experimental | Dietary Supplement: with FlavanolYoung patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols). |
| Young without Flavanol | Placebo comparator | Dietary Supplement: without FlavanolYoung patients (< 45 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols . |
| Old with Flavanol | Experimental | Dietary Supplement: with FlavanolOld patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink with flavanols ( 2x400 mg Flavanols). |
| Old without Flavanol | Placebo comparator | Dietary Supplement: without FlavanolYoung patients (>60 years) will get twice daily from1 week vor catheterisation till one week after catheterisation drink without flavanols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- planed catheterization, that has be done via Arteria radialis
Key exclusion criteria (7 listed)
- acute infection (CRP>0.5 mg/dl)
- malignant diseases
- heart failure (NYHA III-IV)
- renal failure (GFR<60 ml/min)
- profoundly atrial fibrilation
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 |
|---|---|---|
| with FlavanolPatient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization. | Dietary supplement | Old with Flavanol, Young with Flavanol |
| without FlavanolPatient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization. | Dietary supplement | Old without Flavanol, Young without Flavanol |
Primary outcome
Increase of Endothelial Function of Arteria radialis
Time frame: week 2
Change from Baseline Endothelial Function of Arteria radialis measured with Flow Mediated Dilation (FMD) after catheterization
1 secondary outcome
Degree of intimal Injury after Catheterization
Time frame: 1 month
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 15 May 2018.
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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.
Roberto Sansone, MD principal investigator
Division of Cardiology, Pulmonology and Vascular Medicine, University Hospital Dusseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with Flavanol and without Flavanol in people with Endothelial Dysfunction, run by Klinik für Kardiologie, Pneumologie und Angiologie at 1 site in Germany.
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 1 inclusion and 7 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 15 May 2018. 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Increase of Endothelial Function of Arteria radialis (time frame: week 2). 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 15 May 2018.