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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK123104 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The main study will be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with end-stage-kidney-disease treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg to reduce rates of intradialytic hypotension. The target systolic blood pressure of <140 mmHg in both treatment groups will be achieved using an algorithm of dry weight adjustment and anti-hypertensive medication adjustment.
The main study be a two arm 10-month, cross-over randomized controlled trial of 200 participants treated with in-center hemodialysis in the Seattle and San Francisco area comparing a strategy of targeting home vs. pre-dialysis systolic blood pressure <140 mmHg in reducing rates of intradialytic hypotension. The target systolic blood pressure of 100-140 mmHg will be achieved using an algorithm of volume management and anti-hypertensive medication adjustment every two weeks. Home blood pressure measures will be recorded throughout via a mobile health blood pressure monitor over the 10-month study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Systolic Blood Pressure <140 mmHg | Experimental | Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <140 mmHg. |
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| Pre-Dialysis Systolic Blood Pressure <140 mmHg | Active Comparator | Participants will have their blood pressure taken by an automated blood pressure device by dialysis unit staff using regular dialysis unit equipment according to usual clinical care. Pre-dialysis blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a pre-dialysis systolic blood pressure target of <140 mmHg. |
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| Home Systolic Blood Pressure <130 mmHg | Other | This will be an optional, exploratory 2 month study at the end of the primary 10-month trial. Participants will take their home blood pressure two times per week (one in the morning and one in the evening) on non-dialysis days, ideally mid-week. Home blood pressures will be reviewed every two weeks and dry weight and medications adjusted accordingly to reach a home systolic blood pressure target of <130 mmHg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry weight target adjustment | Other | Target dry weight will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intradialytic hypotension (IDH), defined as systolic blood pressure<90 mmHg during dialysis | Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of IDH | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue by SONG-HD Score | Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on patient reported fatigue, as ascertained by the SONG-HD Fatigue Score (PMID: 33093215) | 10 months |
| Cramping |
| Measure | Description | Time Frame |
|---|---|---|
| Separation of blood pressures | Determine whether the intervention is able to achieve a home systolic blood pressure <130mmHg in this optional study. | 2 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nisha Bansal, MD | University of Washington | Principal Investigator |
| Chi-yuan Hsu, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States | ||
| University of Washington |
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| Anti-hypertensive medications | Drug | Anti-hypertensive medications will be adjusted every 2 weeks to reach the home or pre-dialysis systolic blood pressure target. Adjustment of currently prescribed anti-hypertensive medications will be prioritized before starting new medications. Only standard anti-hypertensive medications will be used, such as RAAS inhibitors, beta-blockers, calcium channel blockers and diuretics. |
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Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on frequency of cramping
| 10 months |
| Rates of hospitalizations for cardiovascular events and volume overload | Test the effect of treating home SBP <140mmHg vs a pre-dialysis SBP <140mmHg on rates of hospitalizations for cardiovascular events and volume overload | 10 months |
| Correlation between pre-dialysis and home SBP | Evaluate the correlation between pre-dialysis and home SBP under different treatment strategies | 10 months |
| Seattle |
| Washington |
| 98104 |
| United States |