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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is 1) to determine what physiologic factors (extracellular fluid overload or vasoconstriction) contribute more to increased blood pressure levels between dialysis treatments in hemodialysis patients whose blood pressure increases and decreases during hemodialysis and 2) to determine whether carvedilol provides better control of blood pressure between dialysis treatments than prazosin in patients whose blood pressure increases during dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol (for Aim 3 only) | Eligible case subjects from aims 1-2 will participate in a randomized crossover study where each subject will receive carvedilol and prazosin for 8 weeks each(under randomized treatment sequence) with a 1 week washout period included in between treatments. The first arm will include subjects that are assigned to the randomization sequence: Carvedilol x 8 weeks (titrated up to 50 mg po bid), washout x 1 week, Prazosin x 8 weeks (titrated up to 16 mg daily) |
| |
| Prazosin (for Aim 3 only) | Eligible case subjects from aims 1-2 will participate in a randomized crossover study where each subject will receive carvedilol and prazosin for 8 weeks each(under randomized treatment sequence) with a 1 week washout period included in between treatments. The first arm will include subjects that are assigned to the randomization sequence: Prazosin x 8 weeks, washout x 1 week, Carvedilol x 8 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol vs. Prazosin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Extracellular Body Water to Total Body Water | Expected recruitment is 4-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Endothelin-1 from pre to post dialysis | Expected recruitment is 4-5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vascular Resistance from pre to post dialysis | Expected recruitment is 4-5 years | |
| Change in Asymmetric Dimethylarginine From pre to post dialysis | Expected recruitment is 4-5 years | |
Inclusion Criteria (for Aims 1 and 2):
Inclusion criteria for Aim 3 includes the case subjects described above.
Exclusion Criteria:
For Aims 1 and 2:
For Case subjects participating in Aim 3:
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This study population includes hypertensive hemodialysis patients.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35999520 | Derived | Jung J, Jeon-Slaughter H, Nguyen H, Patel J, Sambandam KK, Shastri S, Van Buren PN. Hyperphosphatemia and its relationship with blood pressure, vasoconstriction, and endothelial cell dysfunction in hypertensive hemodialysis patients. BMC Nephrol. 2022 Aug 23;23(1):291. doi: 10.1186/s12882-022-02918-0. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Serum collection for measurement of endothelin-1, asymetic dimethylarginine
| Change in Angiotensin II from pre to post dialysis |
| Expected recruitment is 4-5 years |