Blood Pressure in Dialysis Patients (BID)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Hypertension Renal Failure Chronic Requiring Hemodialysis Fluid Overload |
Drug: Antihypertensive Agents Other: Dry weight Challenge Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Blood Pressure in Dialysis Patients (BID Study) |
- Feasibility and safety of randomizing patients to a low (110-140 mm Hg) and standard (155-165 m Hg)pre-dialysis BP Goal [ Time Frame: one year ] [ Designated as safety issue: Yes ]To assess the separation achieved between arms over one year. To assess rates of intradialytic hypotension requiring intervention, SAEs, hospitalizations, CV-related hospitalizations between treatment arms
- Change in LV mass [ Time Frame: One year ] [ Designated as safety issue: No ]LV mass will be measured by MRI at baseline and one year after randomization
- Health-related quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]HRQOL will be assessed using the SF-36, and the Fact fatigue scale and a validated question about dialysis recovery time at baseline and one year after randomization
- Residual Renal Function [ Time Frame: One year ] [ Designated as safety issue: No ]RRF will be measured quarterly throughout the trial and will be compared across treatment arms
- Feasibility of Performing Standardized Dialysis Unit BP Readings [ Time Frame: One year ] [ Designated as safety issue: No ]WE will assess adherence rates to standardized procedures for pre-dialysis Dialysis unit BP readings throughout the trial
- Feasibility of home BP monitoring [ Time Frame: one year ] [ Designated as safety issue: No ]We will assess the feasibility of home BP monitoring over one year in a HD population. To evaluate the feasibility of using home monitoring in the full-scale study, we will calculate the proportion of the protocol-specified times the patients actually do home monitoring. This will be summarized by treatment arm and by clinical center and will be related to baseline characteristics to ascertain what factors are associated with successful implementation in the treatment arms.
- Feasibility of ambulatory BP monitoring [ Time Frame: one year ] [ Designated as safety issue: No ]44-hour ABPM: Monitoring will be considered to be feasible if completed for 75% of expected times in each treatment group. Successful completion of a 44-hour ABPM session requires that at least 80% of expected readings for that sitting are obtained. To evaluate the feasibility of using 44-hour ABPM in the full-scale study, we will calculate the proportion of times patients do 44-hour ABPM. This will be summarized by treatment arm, by clinical center & will be related to baseline characteristics to ascertain what factors are associated with successful implementation in the treatment arms.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treatment to a low BP goal
Treatment to a pre-dialysis standardized dialysis unit systolic blood pressure of 110-140 mm Hg
|
Drug: Antihypertensive Agents
Study formulary consists of ACE/ARB, B-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 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
Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight
Extend dialysis treatment time and re-challenge estimated dry weight
|
|
Placebo Comparator: Treatment to standard BP goal
Treatment to a pre-dialysis Standardized dialysis unit systolic BP of 155-165 mm Hg
|
Drug: Antihypertensive Agents
Study formulary consists of ACE/ARB, B-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 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Age ≥ 18 years
- On thrice weekly maintenance hemodialysis for greater than 90 days
- Two-week average pre-dialysis RDUSYS BPM >=155 mm Hg or if less than 155 on antihypertensive medications as follows: at least 1 med for RDUSYS BPM 150-154, 2 meds for RDUSYS BPM 145-149; 3 meds for RDUSYS BPM 140-144. Patient and physician must agree to backtitrate medications if RDU SYS BPM <155.
Exclusion Criteria:
- Two- week average, pre-dialysis mid-week SDUSBPM ≥180 mmHg on maximal doses of ≥ 4 antihypertensive agents;
- Inability to measure blood pressures in an upper arm;
- History of inter or post-dialytic hypotension (defined as systolic blood pressure <90 mmHg) within the past 2 weeks or inter- or post- dialytic hypotension requiring hospitalization (including emergency room visit) and/or the use of midodrine in the past 6 months;
- Required one or more urgent, unscheduled dialysis treatment for congestive heart failure in the past 3 months (other than in an incident patient at the time of starting dialysis);
- Acute myocardial infarction, unstable angina or stroke/ TIA in past three the 3 months;
- Severe aortic valve stenosis (valve area <1cm 2) carotid artery stenosis (>70% stenosis);
- Known abdominal aortic aneurysm >5 cm in diameter or thoracic aortic aneurysm of any diameter;
- Body mass index >40 kg/m2 or arm circumference > 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff;
- Life expectancy <1 year;
- A living donor, kidney transplant, or switch to peritoneal dialysis scheduled within the next year;
- Significant cognitive impairment;
- spKt/V ≤1.2 in the past 2 months;
- Active liver disease;
- Active alcohol or substance abuse including narcotics within the past year;
- Contraindication to cardiac MRI;
- Current or planned pregnancy within the next year;
- Unwillingness to consent to pregnancy test and/or use of birth control if of childbearing potential;
- Suspicion that the participant will not be willing or able to adhere to prescribed medications and study protocol;
- Incarcerated;
- Significant concern about the study expressed by spouse, significant other, family member primary nephrologist or primary care physician;
- Participation in another intervention study;
- Unable to speak or understand English or Spanish;
- Plan to relocate within one year;
- participation in another intervention study .
During the screening pre-randomization phase, eligibility of potential subjects will be documented and evaluated using information in the On-Line Randomization Screen. Patients will be instructed in study design, objectives, and procedures, after which informed consent will be obtained. The study coordinator and site investigator should review this pre-randomization data with attention to judging the patient's ability to adhere to study protocols. A maximum of 12-weeks will be allowed between the screening visit and randomization. If over 12-weeks have elapsed, then potential subjects will need to be re-screened. Eligible participants will be instructed to bring their medications to the baseline visit.
The site PI and/or study coordinator will rescreen patients who appear to meet the study entry criteria using the Blood Pressure in Hemodialysis Pilot Study Eligibility Checking Form. The Blood Pressure in Hemodialysis Pilot Study Screening Physical Exam and Study Questionnaire Form will be completed for potential subjects who provide informed consent to assess eligibility for the study. For women of childbearing potential, a urine pregnancy test will be done at a local lab and the results documented on this form.
Contacts and Locations| Contact: Dana Miskulin, MD, MS | 617 636 9936 | dmiskulin@tuftsmedicalcenter.org |
| Contact: Philip Zager, MD | 505-247-4044 | pzag@unm.edu |
| United States, California | |
| Satellite Healthcare, Inc. | Recruiting |
| San Jose, California, United States, 95128 | |
| Contact: Brigitte Schiller, MD 650-404-3640 schillerB@satellitehealth.com | |
| Contact: Sheila Doss-McQuitty, RBSN, RN 650-404-3621 dosss@satellitehealth.com | |
| Principal Investigator: Brigitte Schiller, MD | |
| United States, Massachusetts | |
| DCI Boston - Tufts | Recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Contact: Dana Miskulin, MD 617-636-6389 dmiskulin@tuftsmedicalcenter.org | |
| Contact: Shana Haynes 617-636-2263 shaynes1@tuftsmedicalcenter.org | |
| Principal Investigator: Dana Miskulin, MD | |
| DaVita | Recruiting |
| Boston, Massachusetts, United States, 02118 | |
| Contact: Dana Miskulin, MD 617-636-9936 dmiskulin@tuftsmedicalcenter.org | |
| DCI Somerville | Recruiting |
| Somerville, Massachusetts, United States, 02145 | |
| Contact: Dana Miskulin, MD 617-636-9936 dmiskulin@tuftsmedicalcenter.org | |
| United States, New Mexico | |
| Dialysis Clinic, Inc.- ABQ East | Recruiting |
| Albuquerque, New Mexico, United States, 87110 | |
| Contact: Philip Zager, MD 505-247-4044 pzag@unm.edu | |
| Contact: Rodrigo Madero, RN 505-247-4044 rodrigo.madero@dciinc.org | |
| Dialysis Clinic, Inc. | Recruiting |
| Albuqueruqe, New Mexico, United States, 87102 | |
| Contact: Philip G Zager, MD 505-247-4044 pzag@unm.edu | |
| Contact: Rodrigo Madero, RN 505-247-4044 rodrigo.madero@dciinc.org | |
| Principal Investigator: Philip Zager, MD | |
| United States, Pennsylvania | |
| DCI Point Breeze | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15221 | |
| Contact: Mark Unruh, MD 412-647-3700 unruhm@dom.pitt.edu | |
| Contact: Manisha Jhamb, MD 412-647-8394 jhamb@upmc.edu | |
| Principal Investigator: Mark Unruh, MD | |
| United States, South Carolina | |
| DCI James Island | Recruiting |
| Charleston, South Carolina, United States, 29412 | |
| Contact: David Ploth, MD 843-792-4123 plothdw@musc.edu | |
| Contact: Caroline Counts, MSN, RN 843-792-8980 counts@musc.edu | |
| Principal Investigator: David Ploth, MD | |
| DCI Azalea Place | Recruiting |
| North Charleston, South Carolina, United States, 29406 | |
| Contact: David Ploth, MD 843-792-4123 plothdw@musc.edu | |
| Study Chair: | Philip Zager, MD | University New Mexico |
| Principal Investigator: | Jennifer Gassman, PhD | The Cleveland Clinic |
| Principal Investigator: | Dana Miskulin, MD | Tufts Medical Center |
| Principal Investigator: | David Ploth, MD | Medical University of South Carolina |
More Information
No publications provided
| Responsible Party: | University of New Mexico |
| ClinicalTrials.gov Identifier: | NCT01421771 History of Changes |
| Other Study ID Numbers: | 1R01DK083424-01A1 |
| Study First Received: | August 16, 2011 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Antihypertensive Agents Hypertension Kidney Failure, Chronic Renal Insufficiency Water Intoxication Vascular Diseases Cardiovascular Diseases Renal Insufficiency, Chronic Kidney Diseases |
Urologic Diseases Water-Electrolyte Imbalance Metabolic Diseases Poisoning Substance-Related Disorders Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013