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The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Flecainide will be used for PVC suppression in a randomized, double-blinded, crossover fashion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVC Suppression then Placebo | Placebo Comparator | This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. |
|
| Placebo then PVC Suppression | Placebo Comparator | This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVC Suppression using Flecainide | Drug | Flecainide will be administered to result in a reduction in PVC burden. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Arterial Pressure | Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements. | Baseline and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Muscle Sympathetic Nerve Activity | Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats. | Baseline and 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baroreflex Gain | Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure. | Baseline and 28 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed H Hamdan, MD, MBA | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | PVC Suppression Then Placebo | This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. |
| FG001 | Placebo Then PVC Suppression | This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | PVC Suppression Then Placebo | This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Arterial Pressure | Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements. | Mean arterial blood pressure values were not available at all time points for every patient. Data on subjects who completed the study is presented here and may not reflect changes seen in a larger population. | Posted | Mean | Standard Deviation | mmHg | Baseline and 28 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Base 1 to PVC Suppression | This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. Adverse events during baseline to PVC suppression in the group that received flecainide (PVC suppression) first. |
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This study was terminated prematurely due to a loss of staff available to make the technical measurements involved. The small number of data points available lead us to conclude the data is uninterpretable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Wasmund, PhD | University of Wisconsin | 801-587-3740 | stephen.wasmund@carma.utah.edu |
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005424 | Flecainide |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| No PVC Suppression using Placebo | Drug | Placebo (sugar pills) will be given to result in no alteration in PVC burden. |
|
| BG001 | Placebo Then PVC Suppression | This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| PVC Burden | Mean | Standard Deviation | % of heartbeats |
|
| OG001 | Change From Base 2 to no PVC Suppression | This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first. |
| OG002 | Change From Base 1 to no PVC Suppression | This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. Change in BP values from first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first. |
| OG003 | Change From Base 2 to PVC Suppression | This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. Change in BP values from 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first. |
|
|
| Secondary | Change in Muscle Sympathetic Nerve Activity | Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats. | SNA values were not obtained in many of the participants in various groups above due to technical difficulties. Data on subjects who underwent the measurement are presented here and may not reflect changes seen in a larger population. | Posted | Number | bursts / 100 heartbeats | Baseline and 28 days |
|
|
|
| Other Pre-specified | Change in Baroreflex Gain | Arterial baroreflex gain is calculated as slope of the relationship between cardiac cycle length and the corresponding change in systolic blood pressure. | Arterial baroreflex gain values were not available at all time points. In one subject, gain could not be calculated because they were in bigeminy. Data on subjects who completed the study is presented here and may not reflect changes seen in a larger population. | Posted | Mean | Standard Deviation | ms/mmHg | Baseline and 28 days |
|
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Base 2 to no PVC Suppression | This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. Adverse events during 2nd baseline (washout) to PVC suppression in the group that received flecainide (PVC suppression) first. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Base 1 to no PVC Suppression | This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. Adverse events during first baseline to no PVC suppression in the group that received placebo (no PVC suppression) first. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG003 | Base 2 to PVC Suppression | This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. No PVC Suppression using Placebo: Placebo (sugar pills) will be given to result in no alteration in PVC burden. PVC Suppression using Flecainide: Flecainide will be administered to result in a reduction in PVC burden. Adverse events during 2nd baseline (washout) to PVC suppression in the group that received placebo (no PVC suppression) first. | 0 | 4 | 0 | 4 | 0 | 4 |
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| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |