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Blood Pressure in Dialysis Patients (BID)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01421771
First Posted: August 23, 2011
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Tufts Medical Center
Medical University of South Carolina
University of Pittsburgh
The Cleveland Clinic
Case Western Reserve University
Information provided by (Responsible Party):
University of New Mexico
August 16, 2011
August 23, 2011
January 6, 2017
October 2011
January 2016   (Final data collection date for primary outcome measure)
Feasibility and safety of randomizing patients to an intensive (110-140 mm Hg) and standard (155-165mm Hg)pre-dialysis standardized BP Goal [ Time Frame: one year ]
To assess the safety and feasibility of randomizing patients to each of the BP arms To assess rates of intradialytic hypotension requiring intervention, SAEs, hospitalizations, CV-related hospitalizations between treatment arms
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 ]
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
Complete list of historical versions of study NCT01421771 on ClinicalTrials.gov Archive Site
  • Change in LV mass [ Time Frame: One year ]
    LV mass will be measured by MRI at baseline and one year after randomization
  • Adverse events, serious adverse events, major CVD events and mortality [ Time Frame: One year ]
    Adverse events, serious adverse events, major CVD events and mortality will be evaluated over one year across study arms
  • Health-related quality of life [ Time Frame: One year ]
    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
  • Change in LV mass [ Time Frame: One year ]
    LV mass will be measured by MRI at baseline and one year after randomization
  • Health-related quality of life [ Time Frame: One year ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Not Provided
Not Provided
 
Blood Pressure in Dialysis Patients
Blood Pressure in Dialysis Patients (BID Study)
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:

  1. What are the estimated recruitment, accrual and retention rates?
  2. What proportions of patients in each arm will achieve and maintain SBP within the assigned target and will the investigators achieve equal or greater than 10mmHg separation in the average SBP between the two arms?
  3. What are the anticipated adverse and serious adverse events rates within the intensive and standard arms?
  4. What end points should be used in the full-scale trial?
  5. What blood pressure (BP) measurements e.g., routine dialysis unit BP (RDUBPM), standardized dialysis unit BP (SDUBPM), standardized home BP (HBPM) or ambulatory BP monitoring (ABPM) to guide therapy? Although SDUBPM, HBPM and ABPM may be more powerful than RDUBP in predicting clinical outcomes,long term adherence with these techniques has not been demonstrated.

Specific Aims

  1. Establish procedures for SDUBPM, HBPM and ABPM and web-based data entry.
  2. Recruit and randomize patients into two treatment arms with target pre-dialysis SDUSBPM values <140 and < 160 mmHg and measure recruitment, accrual, and dropout rates in each arm.
  3. Assess the feasibility of attaining and maintaining these targets and the degree of SBP separation achieved during a one year intervention.
  4. Measure adherence rates for obtaining protocol SDUBPM, HBPM and ABPM over the one-year intervention.
  5. Assess the safety of treating participants to the study's SBP targets by measuring occurrence rates of CVD and non-CVD morbidity and mortality and other adverse and serious adverse events in each arm.
  6. Compare the differences in changes in left ventricular mass index (LVMI), aortic pulse wave velocity(APWV), and aortic distensibility, respectively, between the two study arms.
  7. Conduct statistical analyses to inform the design of the full-scale study.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Hypertension
  • Renal Failure Chronic Requiring Hemodialysis
  • Blood Pressure
  • Dialysis
  • Drug: 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

  • Other: 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
  • Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight
    Extend dialysis treatment time and re-challenge estimated dry weight
  • Active Comparator: Treatment to an intensive BP goal
    Treatment to a pre-dialysis standardized dialysis unit systolic blood pressure of 110-140 mm Hg
    Interventions:
    • Drug: Antihypertensive Agents
    • Other: Dry weight Challenge
    • Dietary Supplement: 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
    Interventions:
    • Drug: Antihypertensive Agents
    • Other: Dry weight Challenge
    • Dietary Supplement: Extend dialysis treatment time and re-challenge estimated dry weight
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
June 2016
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria

  1. Age ≥ 18 years
  2. On thrice weekly maintenance hemodialysis for greater than 90 days
  3. For entry into baseline period: 2-week average RDUSBPM > 155 mm Hg on AHT medications or < 155 mm Hg on ≥ 1 AHT medications For randomization: 2-week average SDUSBPM ≥ 155 mm Hg

Exclusion Criteria:

  1. Two- week average, pre-dialysis mid-week SDUSBPM ≥180 mmHg on maximal doses of ≥ 4 antihypertensive agents;
  2. Inability to measure blood pressures in an upper arm;
  3. 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;
  4. 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);
  5. Acute myocardial infarction, unstable angina or stroke/ TIA in past three the 3 months;
  6. Severe aortic valve stenosis (valve area <1cm 2) carotid artery stenosis (>70% stenosis);
  7. Known abdominal aortic aneurysm >5 cm in diameter or thoracic aortic aneurysm of any diameter;
  8. Body mass index >40 kg/m2 or arm circumference > 52 cm, which precludes measuring blood pressure with the "thigh" blood pressure cuff;
  9. Life expectancy <1 year;
  10. A living donor, kidney transplant, or switch to peritoneal dialysis scheduled within the next year;
  11. Significant cognitive impairment;
  12. spKt/V ≤1.2 in the past 2 months;
  13. Active liver disease;
  14. Active alcohol or substance abuse including narcotics within the past year;
  15. Contraindication to cardiac MRI;
  16. Current or planned pregnancy within the next year;
  17. Unwillingness to consent to pregnancy test and/or use of birth control if of childbearing potential;
  18. Suspicion that the participant will not be willing or able to adhere to prescribed medications and study protocol;
  19. Incarcerated;
  20. Significant concern about the study expressed by spouse, significant other, family member primary nephrologist or primary care physician;
  21. Participation in another intervention study;
  22. Unable to speak or understand English or Spanish;
  23. Plan to relocate within one year;
  24. participation in another intervention study .
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01421771
1R01DK083424-01A1( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of New Mexico
University of New Mexico
  • Tufts Medical Center
  • Medical University of South Carolina
  • University of Pittsburgh
  • The Cleveland Clinic
  • Case Western Reserve University
Study Chair: Philip Zager, MD University New Mexico
Principal Investigator: 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
University of New Mexico
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP