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| ID | Type | Description | Link |
|---|---|---|---|
| NIH K23 HL092297 |
Not provided
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions | |
| Intervention | Active Comparator | Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Progenitor Cells |
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Vasodilation | Measured as percent change in brachial artery diameter from baseline to post shear stress for an individual measurement. Follow up measurements were obtained in intervention subjects 12 weeks later | 12 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Jula K Inrig, MD, MHS | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UTSW Oakcliff Davita Dialysis | Dallas | Texas | 75224 | United States | ||
| UTSW Dallas East Davita Dialysis (Buckner unit) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22700888 | Result | Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto R. Probing the mechanisms of intradialytic hypertension: a pilot study targeting endothelial cell dysfunction. Clin J Am Soc Nephrol. 2012 Aug;7(8):1300-9. doi: 10.2215/CJN.10010911. Epub 2012 Jun 14. | |
| 21757643 | Result | Inrig JK, Van Buren P, Kim C, Vongpatanasin W, Povsic TJ, Toto RD. Intradialytic hypertension and its association with endothelial cell dysfunction. Clin J Am Soc Nephrol. 2011 Aug;6(8):2016-24. doi: 10.2215/CJN.11351210. Epub 2011 Jul 14. |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions |
| FG001 | Intervention | Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions |
| BG001 | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Endothelial Progenitor Cells |
| Follow up measurements were only obtained in the intervention subjects receiving carvedilol | Posted | Median | Inter-Quartile Range | % of mononuclear cells | 12 weeks |
|
First day of enrollment to end of study, an average 12 weeks
Not provided
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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 | Control | Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling >10 mmhg for more than 4/6 of the last dialysis treatment sessions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroparesis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Symptomatic Intradialytic Hypotension | Cardiac disorders | Systematic Assessment | There were 22 episodes total out of 920 dialysis treatments among the 25 patients |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Van Buren | University of Texas Southwestern Medical Center | 214-645-8293 | peter.vanburen@utsouthwestern.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
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| Dallas |
| Texas |
| 75228 |
| United States |
| UTS Dallas Dialysis (Elmbrook) | Dallas | Texas | 75247 | United States |
| 21734087 | Result | Van Buren PN, Kim C, Toto R, Inrig JK. Intradialytic hypertension and the association with interdialytic ambulatory blood pressure. Clin J Am Soc Nephrol. 2011 Jul;6(7):1684-91. doi: 10.2215/CJN.11041210. |
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions
Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
|
|
| Secondary | Flow Mediated Vasodilation | Measured as percent change in brachial artery diameter from baseline to post shear stress for an individual measurement. Follow up measurements were obtained in intervention subjects 12 weeks later | Follow up measurements were only obtained in intervention subjects receiving carvedilol | Posted | Mean | Standard Deviation | % dilation from baseline | 12 weeks |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Intervention | Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of >10 mmhg for more than 4/6 of the last dialysis treatment sessions Carvedilol: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid | 0 | 25 | 5 | 25 | 22 | 25 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hemodialysis Access Revision | Vascular disorders | Systematic Assessment |
|
| Fluid Overload | Cardiac disorders | Systematic Assessment |
|
|
Not provided
Not provided
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| Follow Up FMD |
|
|