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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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).
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)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valsartan | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first AF recurrence on valsartan vs. placebo (time-to-event analysis, log-rank test) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Anderson, MD | Intermountain Healthcare, LDS Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McKay Dee Hospital | Ogden | Utah | 84403 | United States | ||
| LDS Hospital |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Net rate of NSR in the 2 groups at 24 hours. |
| Salt Lake City |
| Utah |
| 84143 |
| United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D014633 |
| Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |