Left Atrial VolumePhase 4NCT00517322
Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan
A Phase 4 study testing ramipril and irbesartan in people with Left Atrial Volume and Hypertensive Heart Disease, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial summary
Aim of the study is to compare in hypertensive patients the effect of one year therapy with ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial remodelling and diastolic function. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Left Atrial Volume, Hypertensive Heart Disease, Antihypertensive Drugs
- What is being tested?
- ramipril and irbesartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2007to Aug 2010
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mild to moderate essential hypertension
- no antihypertensive treatment
- good quality echocardiogram
Who cannot join
- cardiovascular diseases (AMI, stroke o TIA)
- heart failure, valvular heart disease
- diabetes
- secondary hypertension
- atrial fibrillation
- hepatic and renal severe failure
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University of Insubria-Department of Clinical Medicine
Varese, 21100
anna maria grandi, MD, +39+332 278594, amgrandi@libero.it
anna maria grandi, MD, +39 + 332 278594, amgrandi@libero.it
About this study
Aim of the study is to compare in hypertensive patients the effect of one year therapy with ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial remodelling and diastolic function.
- Conditions
- Left Atrial Volume, Hypertensive Heart Disease, Antihypertensive Drugs, Diastolic Function, Renin Angiotensin System
- Being tested
- ramipril, irbesartan
- Keywords
- left atrial volume, hypertension, ramipril, irbesartan, diastolic function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ramiprilDrug
ramipril 2.5- 5 mg once daily
irbesartanDrug
irbesartan 150-300 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | treatment with ramipril Receives: Drug: ramipril |
| 2 | Experimental | treatment with irbesartan Receives: Drug: irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
left atrial volume
Measured: one year
diastolic function
Measured: one year
Secondary outcomes (1)
systolic and diastolic blood pressure
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2007 (estimated)
- Study startAug 2007
- Study completionAug 2010 (estimated)
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 Left Atrial VolumeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Investigators
- anna maria grandi, MD, Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00517322
- Sponsor's protocol ID
- 1112
- Status last verified
- Aug 2007
- First submitted
- 15 Aug 2007
- Last updated
- 16 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Matsuda M, Matsuda Y. Mechanism of left atrial enlargement related to ventricular diastolic impairment in hypertension. Clin Cardiol. 1996 Dec;19(12):954-9. doi: 10.1002/clc.4960191211.
PubMed 8957600Tsang TS, Barnes ME, Gersh BJ, Bailey KR, Seward JB. Left atrial volume as a morphophysiologic expression of left ventricular diastolic dysfunction and relation to cardiovascular risk burden. Am J Cardiol. 2002 Dec 15;90(12):1284-9. doi: 10.1016/s0002-9149(02)02864-3.
PubMed 12480035Healey JS, Baranchuk A, Crystal E, Morillo CA, Garfinkle M, Yusuf S, Connolly SJ. Prevention of atrial fibrillation with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: a meta-analysis. J Am Coll Cardiol. 2005 Jun 7;45(11):1832-9. doi: 10.1016/j.jacc.2004.11.070.
PubMed 15936615Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.
PubMed 16376782
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Remodelling in Hypertension: Effects of Ramipril or Irbesartan
- ClinicalTrials.gov ID
- NCT00517322
- Acronym / sponsor ID
- 1112
- Conditions
- Left Atrial Volume, Hypertensive Heart Disease, Antihypertensive Drugs, Diastolic Function, Renin Angiotensin System
- Keywords
- left atrial volume, hypertension, ramipril, irbesartan, diastolic function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- Aug 2007
- Study completion
- Aug 2010 (estimated)
- First posted
- 16 Aug 2007 (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.
Aim of the study is to compare in hypertensive patients the effect of one year therapy with ACE-inhibitor (RAMIPRIL) or angiotensin II receptor blocker (IRBESARTAN) on left atrial remodelling and diastolic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ramipriltreatment with ramipril |
| 2 | Experimental | Drug: irbesartantreatment with irbesartan |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mild to moderate essential hypertension
- no antihypertensive treatment
- good quality echocardiogram
Key exclusion criteria (7 listed)
- cardiovascular diseases (AMI, stroke o TIA)
- heart failure, valvular heart disease
- diabetes
- secondary hypertension
- atrial fibrillation
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 |
|---|---|---|
| ramiprilramipril 2.5- 5 mg once daily | Drug | 1 |
| irbesartanirbesartan 150-300 mg once daily | Drug | 2 |
Primary outcome
left atrial volume
Time frame: one year
diastolic function
Time frame: one year
1 secondary outcome
systolic and diastolic blood pressure
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2007.
- Background: PubMed 8957600Matsuda M, Matsuda Y. Mechanism of left atrial enlargement related to ventricular diastolic impairment in hypertension. Clin Cardiol. 1996 Dec;19(12):954-9. doi: 10.1002/clc.4960191211.
- Background: PubMed 12480035Tsang TS, Barnes ME, Gersh BJ, Bailey KR, Seward JB. Left atrial volume as a morphophysiologic expression of left ventricular diastolic dysfunction and relation to cardiovascular risk burden. Am J Cardiol. 2002 Dec 15;90(12):1284-9. doi: 10.1016/s0002-9149(02)02864-3.
- Background: PubMed 15936615Healey JS, Baranchuk A, Crystal E, Morillo CA, Garfinkle M, Yusuf S, Connolly SJ. Prevention of atrial fibrillation with angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: a meta-analysis. J Am Coll Cardiol. 2005 Jun 7;45(11):1832-9. doi: 10.1016/j.jacc.2004.11.070.
- Background: PubMed 16376782Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.
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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.
anna maria grandi, MD principal investigator
Università degli Studi dell'Insubria
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 ramipril and irbesartan in people with Left Atrial Volume and Hypertensive Heart Disease, run by Università degli Studi dell'Insubria at 1 site in Italy.
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 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: status not confirmed, as of the sponsor's last update on 16 Aug 2007. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left atrial volume (time frame: one year). 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?
On the ClinicalTrials.gov record for NCT00517322, 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 16 Aug 2007.