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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL065193-08A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Little is known about how some drugs affect inflammation or clotting factors in people receiving hemodialysis. It is not yet known if these drugs help prevent heart damage as they do in people not undergoing hemodialysis or whether they could increase the risk of heart problems. The purpose of the study is to measure certain chemicals in the blood and see how those chemicals may change during hemodialysis when certain drugs are given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo, then ramipril, then valsartan | Active Comparator | placebo, ramipril, valsartan: Subjects were treated sequentially with placebo, ramipril (5mg/day by mouth), then valsartan (160mg/day by mouth). Each drug was given for 7 days after a 3-week washout. |
|
| Placebo, then valsartan, then ramipril | Active Comparator | placebo, ramipril, valsartan: Subjects were treated sequentially with placebo, valsartan (160mg/day by mouth), then ramipril (5mg/day by mouth). Each drug was given for 7 days after a 3-week washout. |
|
| Ramipril, then placebo, then valsartan | Active Comparator | placebo, ramipril, valsartan: Subjects were treated sequentially with ramipril (5mg/day by mouth), then placebo (once a day by mouth), then valsartan (160mg/day by mouth). Each drug was given for 7 days after a 3-week washout. |
|
| Valsartan, then placebo, then ramipril | Active Comparator | placebo, ramipril, valsartan: Subjects were treated sequentially with valsartan (160mg/day by mouth), then placebo (once a day by mouth), then ramipril (5mg/day by mouth). Each drug was given for 7 days after a 3-week washout. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin 1 Beta | Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo | During dialysis after one week of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| F2-Isoprostanes | Mean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo | During dialysis after one week of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy J Brown, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37323 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22158433 | Result | Gamboa JL, Pretorius M, Todd-Tzanetos DR, Luther JM, Yu C, Ikizler TA, Brown NJ. Comparative effects of angiotensin-converting enzyme inhibition and angiotensin-receptor blockade on inflammation during hemodialysis. J Am Soc Nephrol. 2012 Feb;23(2):334-42. doi: 10.1681/ASN.2011030287. Epub 2011 Dec 8. | |
| 26494370 | Derived | Gamboa JL, Pretorius M, Sprinkel KC, Brown NJ, Ikizler TA. Angiotensin converting enzyme inhibition increases ADMA concentration in patients on maintenance hemodialysis--a randomized cross-over study. BMC Nephrol. 2015 Oct 22;16:167. doi: 10.1186/s12882-015-0162-x. |
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Three consented participants were excluded because of hyperkalemia, hypotension and uncontrollable hypertension.They were enrolled but did not start medication and were considered screen failures. The participants required a washout period from either an agiotensin receptor blocker or an angiotensin converting enzyme inhibitor.
Recruitment started in September 2008 and ended in January 2010 in Vanderbilt outpatients Dialysis Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Ramipril, Then Valsartan | Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences. |
| FG001 | Placebo, Valsartan, Then Ramipril | Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences. |
| FG002 | Ramipril, Then Placebo, Then Valsartan | Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences. |
| FG003 | Valsartan, Then Placebo, Then Ramipril | Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences. |
| FG004 | Ramipril, Valsartan, Then Placebo | Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences. |
| FG005 | Valsartan, Ramipril, Then Placebo | Participants were randomized to treatment with ramipril, valsartan and placebo in one of six possible sequences. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Study Drug |
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| Washout After First Study Drug |
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| Second Study Drug |
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| Washout After Second Study Drug |
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| Third Study Drug |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan |
| 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 | Interleukin 1 Beta | Mean difference in interleukin 1 beta concentration during treatment with ramipril versus treatment with placebo | All participants who completed the three arm treatment. | Posted | Mean | Standard Error | pg/mL | During dialysis after one week of study drug |
|
2 years
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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 | Ramipril | All subjects receiving ramipril |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular ischemia | Nervous system disorders | Systematic Assessment | Patient develop acute occipital infarct without evidence of hemorrhage within the 3 weeks washout period after receiving placebo treatment. The stroke was not felt to be study related by the Data and Safety Monitoring Committee for this study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Both episodes of nausea occurred during valsartan treatment. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nancy J. Brown | Vanderbilt University | 615-343-8701 | nancy.j.brown@vanderbilt.edu |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017257 | Ramipril |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
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| Ramipril, then valsartan, then placebo | Active Comparator | placebo, ramipril, valsartan: Subjects were treated sequentially with ramipril (5mg/day by mouth), then valsartan (160mg/day by mouth), then placebo (once a day by mouth). Each drug was given for 7 days after a 3-week washout. |
|
| Valsartan, then ramipril, then placebo | Active Comparator | placebo, ramipril, valsartan: Subjects were treated sequentially with then valsartan (160mg/day by mouth), then ramipril (5mg/day by mouth), then placebo (once a day by mouth). Each drug was given for 7 days after a 3-week washout. |
|
|
|
| Ramipril | Drug | Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis |
|
|
| Valsartan | Drug | Patients receiving an angiotensin converting enzyme inhibitor or angiotensin receptor blocker before the study underwent washout for 3 weeks. Subjects were treated with study drug for 7 days and each treatment period was separated by a 3-week washout period. Ramipril was given at dose of 2.5mg/d for two days, then 5mg/d for 5 days. Valsartan was given at 80mg/d for 2 days followed by 160mg/d for 5 days. On the seventh day of each treatment blood samples were collected prior two, during and two hours after dialysis |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Placebo | After a three week washout period, the subject will be undertake 3 study periods with one of three treatments, placebo, ramipril or valsartan |
|
|
| Secondary | F2-Isoprostanes | Mean difference in F2-isoprostanes during dialysis between treatment with ramipril or valsartan and placebo | Posted | Mean | Standard Error | pg/mL | During dialysis after one week of study drug |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Valsartan | All subjects receiving valsartan | 0 | 15 | 4 | 15 |
| EG002 | Placebo | All subjects receiving placebo | 1 | 16 | 7 | 15 |
|
|
| Hypotension | Cardiac disorders | Systematic Assessment | One event each during ramipril, valsartan, placebo treatment |
|
| Dry cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Occurred during placebo |
|
| Chest pain not cardiac | Musculoskeletal and connective tissue disorders | Systematic Assessment | Event occurred during placebo |
|
| Pericarditis | Cardiac disorders | Systematic Assessment | Occurred during placebo |
|
| Hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment | 1 event during valsartan, one in a subject during placebo |
|
| Bruising after falling | Skin and subcutaneous tissue disorders | Systematic Assessment | Occurred in subject taking placebo |
|
| Vascular acces complication | Vascular disorders | Systematic Assessment | occurred during placebo |
|
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| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |