Atrial FibrillationPhase 4NCT01233635
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
A Phase 4 study testing no drug, start cozaar and continue cozaar in people with Atrial Fibrillation, run by University of Pittsburgh at 1 site in United States.
Trial summary
In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- no drug, start cozaar and continue cozaar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Nov 2007
- 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
- Subjects must be in atrial fibrillation confirmed by 12 lead EKG.
- blood pressure > 90 mmHg
- Patient without cardiopulmonary symptoms
- 18+ years of age
Who cannot join
- Contraindiction to warfarin
- Recent (within 6 months) MI or cardiac revascularization
- Recent (within 6 months) CVA or TIA
- NYHA Class IV CHF
- Active thyroid disease
- Major hepatic dysfunction
Show all 17Show fewer
- Renal dysfunction (>2 mg/dL)
- Hyperkalemia (>4.6 mEq/L)
- Hyponatremia (<130 mEq/L)
- Currently taking a Vaughn-Williams Type I or III antiarrhythmic drug
- History of ARB intolerance
- Contraindication to ARB therapy
- Pregnancy
- Female of childbearing age
- Age < 18 years of age
- Inability to give informed consent
- Other medical conditions calling 1 year survival into question
Trial locations and contacts
1 site in 1 country.
About this study
In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims:
- To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
- To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele.
- To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.
- Conditions
- Atrial Fibrillation
- Being tested
- no drug, start cozaar, continue cozaar
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no drugOther
none, no drug
start cozaarDrug
start cozaar
continue cozaarDrug
continue cozaar
| Study group | Role | What they receive |
|---|---|---|
| A Group 1 no drug | Experimental | Patients who have not taken ACE/ARB, randomized to no drug. Receives: Other: no drug |
| A Group 2 | Experimental | Patients who have not taken ACE/ARB, randomized to take cozaar. Receives: Drug: start cozaar |
| B | Experimental | Patients currently taking ACE/ARB will have their prescription changed to cozaar. Receives: Drug: continue cozaar |
What is being measured
The primary outcome is the main question the study is designed to answer.
AF burden
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startNov 2005
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: inadequate enrollment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233635
- Sponsor's protocol ID
- 0507061
- Status last verified
- Jan 2016
- First submitted
- 2 Nov 2010
- Last updated
- 23 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
- ClinicalTrials.gov ID
- NCT01233635
- Acronym / sponsor ID
- 0507061
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate enrollment rate
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 3 Nov 2010 (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.
In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims:
- To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
- To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele.
- To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A Group 1 no drug | Experimental | Other: no drugPatients who have not taken ACE/ARB, randomized to no drug. |
| A Group 2 | Experimental | Drug: start cozaarPatients who have not taken ACE/ARB, randomized to take cozaar. |
| B | Experimental | Drug: continue cozaarPatients currently taking ACE/ARB will have their prescription changed to cozaar. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be in atrial fibrillation confirmed by 12 lead EKG.
- blood pressure > 90 mmHg
- Patient without cardiopulmonary symptoms
- 18+ years of age
Key exclusion criteria (17 listed)
- Contraindiction to warfarin
- Recent (within 6 months) MI or cardiac revascularization
- Recent (within 6 months) CVA or TIA
- NYHA Class IV CHF
- Active thyroid disease
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 |
|---|---|---|
| no drugnone, no drug | Other | A Group 1 no drug |
| start cozaarstart cozaar | Drug | A Group 2 |
| continue cozaarcontinue cozaar | Drug | B |
Primary outcome
AF burden
Time frame: 1 year
Results and safety
The study was stopped early (reason given: inadequate enrollment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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Atrial Fibrillation (AF)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 no drug, start cozaar and continue cozaar in people with Atrial Fibrillation, run by University of Pittsburgh 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 4 inclusion and 17 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: stopped early, as of the sponsor's last update on 23 Mar 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 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. 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 was stopped early (reason given: inadequate enrollment rate). Results are not available in the source record.
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?
AF burden (time frame: 1 year). 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 23 Mar 2023.