Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tufts Medical Center | OTHER |
| Medical University of South Carolina | OTHER |
| University of Pittsburgh Medical Center | OTHER |
| The Cleveland Clinic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Hypertension is a major cause of cardiovascular (CV) morbidity and mortality. Although studies in the general population have demonstrated a continuous reduction in CV risk with each mmHg drop in systolic blood pressure (SBP), multiple observational studies conducted in hemodialysis (HD) patients have demonstrated that patients with mild to moderate hypertension may have decreased mortality compared to those with normal blood pressure (BP). The investigators recently reported that among HD patients, those with routine pre-dialysis BP values that met the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (<140/90 mm Hg) had increased mortality compared to patients with mild to moderate hypertension. However, these observational studies included untreated patients in whom low or normal BP may reflect significant cardiac disease or other comorbid conditions. In the setting of reduced vascular compliance and impaired autoregulation, aggressive BP lowering may decrease coronary or cerebral perfusion. Thus, it is unclear if aggressive BP lowering will be harmful or beneficial. A well-designed randomized control trial (RCT) is needed to answer this important question. Prior to conducting a full-scale RCT it is prudent to conduct a pilot study to assess feasibility and inform the design of the former. The investigators propose to conduct a pilot RCT in a prevalent cohort of HD patients to assess the safety and feasibility of treating patients to a low (110-140 mmHg)and standard (155-165) mm Hg pre-dialysis BP target.
Mortality and morbidity among hemodialysis (HD) patients remain unacceptably high, thus there is a compelling need to improve clinical outcomes. Accordingly, the National Kidney Foundation's Kidney Disease Outcome Quality Improvement program (KDOQI) has published a guideline calling for a pre-dialysis systolic blood pressure (SBP) <140 mmHg in HD patients. However, the evidence supporting this guideline was graded as weak since it was largely extrapolated from the general population. Studies in the general population have demonstrated a continuous reduction in cardiovascular risk with each mmHg drop in systolic blood pressure (SBP), extending below levels that were in past considered "normal". The Systolic Blood Pressure Intervention Trial (SPRINT) study has showed a decrease in the composite outcome of CV events and CV mortality among non-diabetic patients at high risk for cardiovascular events by targeting a SBP of <120 mmHg. It is reasonable to postulate that intensive control of BP may be beneficial in HD patients, who in many ways resemble patients in SPRINT except that they have progressed to end stage renal disease. Thus, it is timely to propose conducting a RCT of intensive versus standard control of blood pressure in HD patients.
The investigators recognize that from observational studies suggest that mortality among HD patients may be increased among patients who meet the current KDOQI guideline. Unidentified confounders may have contributed to these surprising findings. The conclusions reached by observational studies in HD patients have often been refuted by randomized controlled trials (RCTs). Therefore, a RCT is needed to determine if a pre-dialysis SBP <140 mmHg specified by KDOQI is an appropriate target. Prior to beginning a full-scale-RCT, it is imperative to conduct a pilot study to demonstrate safety and efficacy and to inform the design of the full-scale study. The pilot study is designed to answer the following questions:
Specific Aims
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment to an intensive BP goal | Active Comparator | Treatment to a pre-dialysis standardized dialysis unit systolic blood pressure of 110-140 mm Hg |
|
| Treatment to standard BP goal | Placebo Comparator | Treatment to a pre-dialysis Standardized dialysis unit systolic BP of 155-165 mm Hg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihypertensive Agents | Drug | Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist. ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Assessed for Intensive (110-140 mm Hg) and Standard (155-165mm Hg) Pre-dialysis Standardized BP Goal | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Number or Participants Assessed for Change in LV Mass | One year |
Not provided
Inclusion Criteria
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philip Zager, MD | University New Mexico | Study Chair |
| Dana Miskulin, PhD | Tufts Medical Center | Principal Investigator |
| Jennifer Gassman, MD | The Cleveland Clinic | Principal Investigator |
| David Ploth, MD | Medical University of South Carolina | Principal Investigator |
| Manisha Jhamb | University of Pittsburgh | Principal Investigator |
| Mahboob Rahman | Case Western Reserve University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dialysis Clinic Inc - Boston | Boston | Massachusetts | 02111 | United States | ||
| DaVita Boston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29212839 | Derived | Miskulin DC, Gassman J, Schrader R, Gul A, Jhamb M, Ploth DW, Negrea L, Kwong RY, Levey AS, Singh AK, Harford A, Paine S, Kendrick C, Rahman M, Zager P. BP in Dialysis: Results of a Pilot Study. J Am Soc Nephrol. 2018 Jan;29(1):307-316. doi: 10.1681/ASN.2017020135. Epub 2017 Dec 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment to an Intensive BP Goal | Standardized predialysis systolic BP of 110-140 mmHg (intensive arm) |
| FG001 | Treatment to Standard BP Goal | Standardized predialysis systolic BP of 155-165 mmHg (standard arm) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| OTHER |
| Case Western Reserve University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Dry weight Challenge | Other | Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal |
|
| Extend dialysis treatment time and re-challenge estimated dry weight | Dietary Supplement | Extend dialysis treatment time and re-challenge estimated dry weight |
|
| Boston |
| Massachusetts |
| 02118 |
| United States |
| Dialysis Clinic Inc - Walden Pond Clinic | Concord | Massachusetts | 01742 | United States |
| Dialysis Clinic Inc - Faulkner | Jamaica Plain | Massachusetts | 02130 | United States |
| Dialysis Clinic Inc - Somerville | Somerville | Massachusetts | 02145 | United States |
| Dialysis Clinic Inc - Albuquerque | Albuquerque | New Mexico | 87102 | United States |
| Dialysis Clinic Inc - Albuquerque South | Albuquerque | New Mexico | 87105 | United States |
| Dialysis Clinic Inc - Albuquerque East | Albuquerque | New Mexico | 87110 | United States |
| Dialysis Clinic Inc - Grants | Grants | New Mexico | 87020 | United States |
| Dialysis Clinic Inc - Rio Rancho | Rio Rancho | New Mexico | 87124 | United States |
| Centers for Dialysis Care East | Cleveland | Ohio | 44106 | United States |
| Centers for Dialysis Care - Shaker Heights | Cleveland | Ohio | 44122 | United States |
| Dialysis Clinic Inc - Oakland | Pittsburgh | Pennsylvania | 15213 | United States |
| Dialysis Clinic Inc - Banksville | Pittsburgh | Pennsylvania | 15216 | United States |
| Dialysis Clinic Inc - Point Breeze | Pittsburgh | Pennsylvania | 15221 | United States |
| Dialysis Clinic Inc - North Hills | Pittsburgh | Pennsylvania | 15237 | United States |
| Dialysis Clinic Inc - Magnolia Court | Charleston | South Carolina | 29403 | United States |
| Dialysis Clinic Inc - West Ashley | Charleston | South Carolina | 29407 | United States |
| Dialysis Clinic Inc - James Island | Charleston | South Carolina | 29412 | United States |
| Dialysis Clinic Inc - East Cooper | Mt. Pleasant | South Carolina | 29464 | United States |
| Dialysis Clinic Inc - Azalea Place | North Charleston | South Carolina | 29406 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment to an Intensive BP Goal | Treatment to a pre-dialysis standardized dialysis unit systolic blood pressure of 110-140 mm Hg Antihypertensive Agents: Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist. ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator Dry weight Challenge: Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal Extend dialysis treatment time and re-challenge estimated dry weight: Extend dialysis treatment time and re-challenge estimated dry weight |
| BG001 | Treatment to Standard BP Goal | Treatment to a pre-dialysis Standardized dialysis unit systolic BP of 155-165 mm Hg Antihypertensive Agents: Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist. ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator Dry weight Challenge: Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal Extend dialysis treatment time and re-challenge estimated dry weight: Extend dialysis treatment time and re-challenge estimated dry weight |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | 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 | Number | 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 | Number of Participants Assessed for Intensive (110-140 mm Hg) and Standard (155-165mm Hg) Pre-dialysis Standardized BP Goal | Posted | Number | participants | one year |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Number or Participants Assessed for Change in LV Mass | Posted | Number | participants | One year |
|
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment to an Intensive BP Goal | Standardized predialysis systolic BP of 110-140 mmHg (intensive arm) | 0 | 62 | 0 | 62 | 0 | 62 |
| EG001 | Treatment to Standard BP Goal | Standardized predialysis systolic BP of 155-165 mmHg (standard arm) | 0 | 64 | 0 | 64 | 0 | 64 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Samiha Mateen | University of New Mexico Health Sciences Center | 505-272-6057 | smateen@salud.unm.edu |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000959 | Antihypertensive Agents |
| ID | Term |
|---|---|
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|