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| Name | Class |
|---|---|
| Relaxera Pharmaceuticals | UNKNOWN |
| McGowan Institute for Regenerative Medicine, University of Pittsburgh | UNKNOWN |
| Relaxera Pharmazeutische Gesellschaft mbH & Co. KG | UNKNOWN |
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Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. The evaluation of new, more effective treatments for preventing AF recurrence remains a critical unmet clinical need. AF is considered a progressive disease that increases in prevalence with age and can convert from "paroxysmal" to "persistent" to "permanent" AF in a single individual. This progression results, in part, from high oxidative stress and progressive adverse electrical changes in the heart. Compelling preclinical and clinical data indicate that Relaxin, a naturally occurring peptide hormone, may reverse the electrical remodeling. Thus, our overall objective is to investigate the effects of Relaxin in Veterans who have failed medical management for symptomatic AF and is referred to Cardiac Electrophysiology Laboratory for catheter ablation and pulmonary vein isolation. We will determine whether Relaxin therapy, in addition to the standard of care, counteracts the oxidative stress-related electrical derangement and reduces the post-ablation AF burden. A unique aspect of this proposal is that it is based in part on observations derived from the basic, translational and computational labs of the PI and co-investigators and from the observations by the PI while caring for patients with AF. As such, this proposal represents a true progression from the bench to the bedside. If successful, our findings may lead to the design of a new, more effective treatment for a major unmet public health problem in the United States as well as the world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care (including ablation) + Placebo x 9mo, then crossover to Relaxin therapy x 3mo | Experimental | Patients receiving the standard of care (which includes catheter ablation) will be treatment in a double blinded manner with (1) Placebo for the first 9 months; and then (2) Relaxin, instead of Placebo, for another 3 months. |
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| Standard of care (including ablation) + Relaxin therapy x 9mo, then crossover to Placebo x 3mo | Experimental | Patients receiving the standard of care (which includes catheter ablation) will be treatment in a double blinded manner with (1) Relaxin for the first 9 months; and then (2) Placebo, instead of Relaxin, for another 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relaxin | Drug | subcutaneous injections of Relaxin once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The Primary Safety Outcome includes the number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 390 days |
| Ratio of the average daily AF burden before and after treatment | The Primary Efficacy Outcome includes the distribution of the ratio of the average daily AF burden before and after treatment over time. The daily AF burden is defined as the daily AF duration multiplied by the number of AF events including atrial ectopy. | 390 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Contact | (412) 822-2222 |
| Name | Affiliation | Role |
|---|---|---|
| Deeptankar DeMazumder, MD, PhD | (1) VA Pittsburgh Health System; (2) McGowan Institute for Regenerative Medicine. | Principal Investigator |
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Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.
Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.
Data will be shared as allowed by applicable VA, state, federal and IP rules and policies.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D020521 | Stroke |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012065 | Relaxin |
| ID | Term |
|---|---|
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Placebo | Drug | subcutaneous injections of Placebo once daily |
|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |