Abdominal Aortic AneurysmPhase 4TEDYNCT01683084
Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
A Phase 4 study testing Telmisartan in people with Abdominal Aortic Aneurysm, run by Palo Alto Veterans Institute for Research at 1 site in United States.
Trial summary
The purpose of this study is to determine if telmisartan is effective in slowing the progression of abdominal aortic aneurysms and reducing circulating concentrations of Abdominal Aortic Aneurysms (AAA) biomarkers. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Telmisartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2012to 10 Nov 2018
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-85 years of age and able to provide written informed consent
- AAA measuring a maximum diameter of 3.5-4.9 cm on CTA or ultrasound
- Stable medication regime for the last six months
- No current indication for AAA repair according to the treating physician or expectation that this will be revised within the next year
- High likelihood of compliance with treatment over 24 months
Who cannot join
- Renal impairment (i.e. creatinine >1.5x upper limit of normal [ULN])
- Known significant renal stenosis (>70%) of one or both renal arteries
- Chronic liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function (i.e. ALT 1.5xULN)
- Electrolyte imbalance
- Active gout
- Current or planned usage of an AT1 blocker or ACE inhibitor
- Previous abdominal aortic surgery
- Currently pregnant or intend to become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System
Palo Alto, California, 94304
About this study
The purpose of this study is to determine if telmisartan is effective in slowing the progression of abdominal aortic aneurysms and reducing circulating concentrations of Abdominal Aortic Aneurysms (AAA) biomarkers.
Read the detailed description
Currently, the only management options for AAA are surgical (open or endovascular) based on ongoing follow-up with imaging at regular intervals. Telmisartan is currently approved for use in the United States by the Food and Drug Administration for management of hypertension. If telmisartan is found to be effective in slowing the progression of abdominal aortic aneurysms, this would provide a new treatment option for patients with AAA disease.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Telmisartan, Placebo
- Keywords
- Abdominal Aortic Aneurysm, AAA, telmisartan
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Active comparator | One 40mg telmisartan pill given once daily for 24 months Receives: Drug: Telmisartan |
| Placebo | Placebo comparator | One 40mg placebo pill given once daily for 24 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA)
Measured: Patients will be followed for two years following enrollment, with AAA growth determined by comparing total AAA volume at baseline and at two years between control and treatment groups.
Secondary outcomes (3)
Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound
Interval assessments of ultrasound-determined diameter will also be performed to reduce the variability of individual ultrasound-derived aortic diameter measurements.
Measured: Comparison between two groups at baseline and two years.
Change in circulating concentrations of AAA biomarkers (serum OPG, OPN, MMP-9 and TGFB-1) on repeated samples
Measured: Comparison between baseline and 2 years (24 months) following enrollment
Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL)
Measured: Comparison between baseline and 24 months between the two groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study start19 Sep 2012
- Primary completion10 Nov 2018
- Study completion10 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, James Cook University, Queensland, Australia
- Responsible party
- Principal investigator, Ronald L. Dalman, MD, Palo Alto Veterans Institute for Research
- Investigators
- Ronald L Dalman, M.D., Principal investigator, PAIRE: Stanford University, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683084
- Sponsor's protocol ID
- DAL0041ARG
- Other IDs
- 22647
- Acronym
- TEDY
- Status last verified
- May 2020
- First submitted
- 5 Sep 2012
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Golledge J, Tsao PS, Dalman RL, Norman PE. Circulating markers of abdominal aortic aneurysm presence and progression. Circulation. 2008 Dec 2;118(23):2382-92. doi: 10.1161/CIRCULATIONAHA.108.802074. No abstract available.
PubMed 19047592Golledge J, Pinchbeck J, Tomee SM, Rowbotham SE, Singh TP, Moxon JV, Jenkins JS, Lindeman JH, Dalman RL, McDonnell L, Fitridge R, Morris DR; TEDY Investigators. Efficacy of Telmisartan to Slow Growth of Small Abdominal Aortic Aneurysms: A Randomized Clinical Trial. JAMA Cardiol. 2020 Dec 1;5(12):1374-1381. doi: 10.1001/jamacardio.2020.3524.
PubMed 32845283Xuan H, Xu B, Wang W, Tanaka H, Fujimura N, Miyata M, Michie SA, Dalman RL. Inhibition or deletion of angiotensin II type 1 receptor suppresses elastase-induced experimental abdominal aortic aneurysms. J Vasc Surg. 2018 Feb;67(2):573-584.e2. doi: 10.1016/j.jvs.2016.12.110. Epub 2017 Apr 20.
PubMed 28434702Morris DR, Cunningham MA, Ahimastos AA, Kingwell BA, Pappas E, Bourke M, Reid CM, Stijnen T, Dalman RL, Aalami OO, Lindeman JH, Norman PE, Walker PJ, Fitridge R, Bourke B, Dear AE, Pinchbeck J, Jaeggi R, Golledge J. TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial. Trials. 2015 Jun 17;16:274. doi: 10.1186/s13063-015-0793-z.
PubMed 26081587
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT01683084
- Acronym / sponsor ID
- TEDY / DAL0041ARG
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal Aortic Aneurysm, AAA, telmisartan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Collaborators
- Medtronic, James Cook University, Queensland, Australia
- Study start
- 19 Sep 2012 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- 10 Nov 2018 (actual)
- First posted
- 11 Sep 2012 (estimated)
- 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.
The purpose of this study is to determine if telmisartan is effective in slowing the progression of abdominal aortic aneurysms and reducing circulating concentrations of Abdominal Aortic Aneurysms (AAA) biomarkers.
Detailed description
Currently, the only management options for AAA are surgical (open or endovascular) based on ongoing follow-up with imaging at regular intervals. Telmisartan is currently approved for use in the United States by the Food and Drug Administration for management of hypertension. If telmisartan is found to be effective in slowing the progression of abdominal aortic aneurysms, this would provide a new treatment option for patients with AAA disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Active comparator | Drug: TelmisartanOne 40mg telmisartan pill given once daily for 24 months |
| Placebo | Placebo comparator | Drug: PlaceboOne 40mg placebo pill given once daily for 24 months |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 50-85 years of age and able to provide written informed consent
- AAA measuring a maximum diameter of 3.5-4.9 cm on CTA or ultrasound
- Stable medication regime for the last six months
- No current indication for AAA repair according to the treating physician or expectation that this will be revised within the next year
- High likelihood of compliance with treatment over 24 months
Key exclusion criteria (8 listed)
- Renal impairment (i.e. creatinine >1.5x upper limit of normal [ULN])
- Known significant renal stenosis (>70%) of one or both renal arteries
- Chronic liver disease (i.e. cirrhosis or hepatitis) or abnormal liver function (i.e. ALT 1.5xULN)
- Electrolyte imbalance
- Active gout
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 |
|---|---|---|
| Telmisartan | Drug | Telmisartan |
| Placebo | Drug | Placebo |
Primary outcome
Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA)
Time frame: Patients will be followed for two years following enrollment, with AAA growth determined by comparing total AAA volume at baseline and at two years between control and treatment groups.
3 secondary outcomes
Change in maximum infrarenal AAA diameter and aortic distensibility on repeat ultrasound
Time frame: Comparison between two groups at baseline and two years.
Change in circulating concentrations of AAA biomarkers (serum OPG, OPN, MMP-9 and TGFB-1) on repeated samples
Time frame: Comparison between baseline and 2 years (24 months) following enrollment
Quality of life assessed by the 12-item Assessment of Quality of Life (AQoL)
Time frame: Comparison between baseline and 24 months between the two groups.
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 26 May 2020.
- Background: PubMed 19047592Golledge J, Tsao PS, Dalman RL, Norman PE. Circulating markers of abdominal aortic aneurysm presence and progression. Circulation. 2008 Dec 2;118(23):2382-92. doi: 10.1161/CIRCULATIONAHA.108.802074. No abstract available.
- Derived from this study: PubMed 32845283Golledge J, Pinchbeck J, Tomee SM, Rowbotham SE, Singh TP, Moxon JV, Jenkins JS, Lindeman JH, Dalman RL, McDonnell L, Fitridge R, Morris DR; TEDY Investigators. Efficacy of Telmisartan to Slow Growth of Small Abdominal Aortic Aneurysms: A Randomized Clinical Trial. JAMA Cardiol. 2020 Dec 1;5(12):1374-1381. doi: 10.1001/jamacardio.2020.3524.
- Derived from this study: PubMed 28434702Xuan H, Xu B, Wang W, Tanaka H, Fujimura N, Miyata M, Michie SA, Dalman RL. Inhibition or deletion of angiotensin II type 1 receptor suppresses elastase-induced experimental abdominal aortic aneurysms. J Vasc Surg. 2018 Feb;67(2):573-584.e2. doi: 10.1016/j.jvs.2016.12.110. Epub 2017 Apr 20.
- Derived from this study: PubMed 26081587Morris DR, Cunningham MA, Ahimastos AA, Kingwell BA, Pappas E, Bourke M, Reid CM, Stijnen T, Dalman RL, Aalami OO, Lindeman JH, Norman PE, Walker PJ, Fitridge R, Bourke B, Dear AE, Pinchbeck J, Jaeggi R, Golledge J. TElmisartan in the management of abDominal aortic aneurYsm (TEDY): The study protocol for a randomized controlled trial. Trials. 2015 Jun 17;16:274. doi: 10.1186/s13063-015-0793-z.
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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.
Ronald L Dalman, M.D. principal investigator
PAIRE: Stanford University, VA Palo Alto Health Care System
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 Telmisartan in people with Abdominal Aortic Aneurysm, run by Palo Alto Veterans Institute for Research at 1 site in United States.
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 5 inclusion and 8 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 26 May 2020. 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 United States. 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.
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?
Rate of AAA growth assessed by total infrarenal aortic volume measured on computed tomography angiography (CTA) (time frame: Patients will be followed for two years following enrollment, with AAA growth determined by comparing total AAA volume at baseline and at two years between control and treatment groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683084, which also lists 4 linked publications.
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 26 May 2020.