Atrial FibrillationPhase 4NCT00343499
The Use of DIOVAN to Reduce Post-Cardioversion Recurrence of Atrial Fibrillation Trial (the DRAFT Trial)
A Phase 4 study testing valsartan in people with Atrial Fibrillation, run by Intermountain Health Care, Inc. at 3 sites in United States.
Trial summary
24 week, single center, prospective, randomized, double-blind treatment study of valsartan (80 mg/bid, increased to 160 mg/bid) or placebo in addition to other general medical therapy in patients with persistent atrial fibrillation (AF) undergoing electrical cardioversion to restore normal sinus rhythm (SR). 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?
- valsartan
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2004to Jul 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
- The patient (male or non-pregnant female) must be >18 years of age
- Have ECG documented AF at the time of enrollment into the study
- Require (be scheduled for) electrical cardioversion
- Female patients of childbearing potential must have a documented negative pregnancy test during the index hospitalization.
- The patient or legally authorized representative willing to give written informed consent, prior to the procedure, using the ICF approved by the UCR Institutional Review Board. Surrogate consent must be given per CV Research SOP.
- Have a serum potassium level between 3.5 and 5.5 meq/L
- If diabetic, have a hemoglobin A1C level <11%
- NYHA I-II can be enrolled if no hospitalizations for heart failure within 6 months or current, known EF<40%.
Who cannot join
- The patient is unable or unwilling to cooperate with the study follow-up procedures.
- Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- Current diagnosis of angina pectoris (no events within a period of 3 months prior to Visit 1 (V1)
- History or current diagnosis of symptomatic heart failure (NYHA classes III-IV) or
- documented ejection fraction of < 40 %. Myocardial Infarction within 3 months; coronary revascularization (PCI or CABG), unstable angina within 1 month of V1.
Show all 14Show fewer
- Stroke, deep vein thrombosis (DVT), pulmonary embolism (PE) or transient ischemic attack (TIA) within 3 months of V1.
- Substance or alcohol abuse within 6 months of V1
- Known allergy to any of the drugs administered in the study (angiotensin receptor blocker (ARB) or an angiotensin converting enzyme inhibitor (ACE-I), Valsartan, amiodarone, flecainide or propafenone)
- Any other contraindication listed in the labeling of warfarin or acenocoumarol.
- Patients treated with ARBs or ACE-I within 1 month of V-1
- Impaired renal function defined as a serum creatinine > 2.5 mg/dL
- Evidence of hepatic disease evidenced by an AST or ALT value > 2 times the upper limit of the institution's normal values.
- Significant non-cardiovascular illness or condition likely to result in severe incapacitation or death prior to study completion.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
McKay Dee Hospital
Ogden, Utah, 84403
LDS Hospital
Salt Lake City, Utah, 84143
Dixie Regional Medical Center
St. George, Utah, 84770
About this study
Official title: A Single Center, Randomized Trial to Evaluate the Effects of Diovan to Maintain Sinus Rhythm in Patients With Persistent Atrial Fibrillation
24 week, single center, prospective, randomized, double-blind treatment study of valsartan (80 mg/bid, increased to 160 mg/bid) or placebo in addition to other general medical therapy in patients with persistent atrial fibrillation (AF) undergoing electrical cardioversion to restore normal sinus rhythm (SR).
Read the detailed description
To evaluate the efficacy of valsartan, added to standard AF therapy, to maintain sinus rhythm and extend the interval to first AF recurrence after cardioversion.Evaluate the efficacy of valsartan, begun prior to cardioversion, on the difficulty (number and total energy of CV attempts), the net rate of cardioversion (to SR for >10 minutes), and early AF recurrence rate (within 24 hours)
- Conditions
- Atrial Fibrillation
- Being tested
- valsartan
- Keywords
- atrial fibrillation, valsartan, sinus rhythm, persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test)
Secondary outcomes (4)
Number of CV attempts in order to restore SR in valsartan vs. placebo
Total electrical energy expended in 2 groups to achieve SR
Rate of early AF recurrence (within 24 hours) in the 2 groups after achieving SR
Net rate of NSR in the 2 groups at 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startNov 2004
- Study completionJul 2007
Why it stopped: Inability to recruit
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.
- 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
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Jeffrey L Anderson, MD, Principal investigator, Intermountain Healthcare, LDS Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343499
- Sponsor's protocol ID
- 128-011
- Status last verified
- Aug 2008
- First submitted
- 21 Jun 2006
- Last updated
- 21 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized Trial to Evaluate the Effects of Diovan to Maintain Sinus Rhythm in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00343499
- Acronym / sponsor ID
- 128-011
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, valsartan, sinus rhythm, persistent atrial fibrillation undergoing electrical cardioversion to restore normal sinus rhythm
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Novartis
- Study start
- Nov 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Jun 2006 (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.
24 week, single center, prospective, randomized, double-blind treatment study of valsartan (80 mg/bid, increased to 160 mg/bid) or placebo in addition to other general medical therapy in patients with persistent atrial fibrillation (AF) undergoing electrical cardioversion to restore normal sinus rhythm (SR).
Detailed description
To evaluate the efficacy of valsartan, added to standard AF therapy, to maintain sinus rhythm and extend the interval to first AF recurrence after cardioversion.Evaluate the efficacy of valsartan, begun prior to cardioversion, on the difficulty (number and total energy of CV attempts), the net rate of cardioversion (to SR for >10 minutes), and early AF recurrence rate (within 24 hours)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient (male or non-pregnant female) must be >18 years of age
- Have ECG documented AF at the time of enrollment into the study
- Require (be scheduled for) electrical cardioversion
- Female patients of childbearing potential must have a documented negative pregnancy test during the index hospitalization.
- The patient or legally authorized representative willing to give written informed consent, prior to the procedure, using the ICF approved by the UCR Institutional Review Board. Surrogate consent must be given per CV Research SOP.
Key exclusion criteria (14 listed)
- The patient is unable or unwilling to cooperate with the study follow-up procedures.
- Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
- Current diagnosis of angina pectoris (no events within a period of 3 months prior to Visit 1 (V1)
- History or current diagnosis of symptomatic heart failure (NYHA classes III-IV) or
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 |
|---|---|---|
| valsartan | Drug | – |
Primary outcome
Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test)
4 secondary outcomes
Number of CV attempts in order to restore SR in valsartan vs. placebo
Total electrical energy expended in 2 groups to achieve SR
Rate of early AF recurrence (within 24 hours) in the 2 groups after achieving SR
Net rate of NSR in the 2 groups at 24 hours.
Results and safety
The study was stopped early (reason given: Inability to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2008.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Jeffrey L Anderson, MD principal investigator
Intermountain Healthcare, LDS Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing valsartan in people with Atrial Fibrillation, run by Intermountain Health Care, Inc. at 3 sites 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 8 inclusion and 14 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 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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: Inability to recruit). 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?
Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test). 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 21 Aug 2008.