Blood Pressure in Dialysis Patients (BID)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by University of New Mexico.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Tufts Medical Center
Medical University of South Carolina
University of Pittsburgh
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01421771
First received: August 16, 2011
Last updated: March 28, 2012
Last verified: June 2011
  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)

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

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
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
Criteria

Inclusion Criteria

  1. Age ≥ 18 years
  2. On thrice weekly maintenance hemodialysis for greater than 90 days
  3. 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:

  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 .

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421771

Contacts
Contact: Dana Miskulin, MD, MS 617 636 9936 dmiskulin@tuftsmedicalcenter.org
Contact: Philip Zager, MD 505-247-4044 pzag@unm.edu

Locations
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   
Sponsors and Collaborators
University of New Mexico
Tufts Medical Center
Medical University of South Carolina
University of Pittsburgh
Investigators
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
Vascular Diseases
Cardiovascular Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014