We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 248 for:    pragmatic | Canada

CENtral Blood Pressure Targeting: A Pragmatic RAndomized Pilot triaL in Advanced Chronic Kidney Disease (CENTRAL-CKD)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05163158
Recruitment Status : Recruiting
First Posted : December 20, 2021
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Remi Goupil, MD MSc, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Brief Summary:

Background: Emerging data favors aortic blood pressure (BP) over brachial cuff BP in predicting CV and renal complications, as this BP directly impacts the heart, brain and kidneys. In parallel, central BP measuring devices have been developed that are more accurate towards aortic BP and easy to use without training. In no other condition than advanced chronic kidney disease (CKD) is BP control as important, since undertreatment is associated with adverse CV events and progression towards end-stage kidney disease (ESKD), while overtreatment similarly leads to adverse CV events and injurious falls but also acute kidney injury which can precipitate ESKD. To this day, standard BP management relies on brachial cuff BP, which is an imprecise surrogate marker of aortic BP, more so in the advanced CKD population. Considering that these patients have a high risk of CV morbidity and mortality and is a group where brachial BP may be the least reliable, it can be beneficial to manage hypertension in this population using central BP measurements. With the development of affordable and easy to use central BP devices, routine use of central BP in hypertension would now become a reality. However, the superiority of central BP to traditional brachial cuff BP in regard to clinical outcomes will first need to be demonstrated.

Objectives: To demonstrate that targeting central BP in advanced CKD patients as opposed to brachial cuff BP is feasible and results in lower arterial stiffness after 12 months of follow-up.

Methods: The CENTRAL-CKD trial is an investigator-initiated prospective parallel-group 1:1 randomized double-blinded multicenter pragmatic pilot trial. Patients with CKD stages 4 and 5 (n=116) will be randomized to either a central systolic BP target < 130 mmHg (intervention) or brachial systolic BP target < 130 mmHg (standard care). Central and brachial BP will be concomitantly measured, with treating physicians, patients and investigators blinded towards allocation. As this trial is of a pragmatic design, all other aspects of BP and CKD management, including anti-hypertensive treatment-related decisions, diastolic BP targets, and clinical and laboratory follow-ups will be at the discretion of the attending Nephrologist. The primary outcomes include feasibility of large-scale trial using prespecified criteria and aortic stiffness (carotid-femoral pulse wave velocity) at 12 months. Other cardiovascular, renal, quality of life and safety outcomes will be evaluated.

Importance: CENTRAL-CKD is designed as a pilot trial aimed at providing the framework and justification to proceed to a large-scale trial with adequate power to detect the impact of the proposed intervention on clinically important outcomes.


Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Hypertension Other: Central vs brachial systolic blood pressure targeting Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CENtral Blood Pressure Targeting: A Pragmatic RAndomized Pilot triaL in Advanced Chronic Kidney Disease
Actual Study Start Date : May 24, 2022
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Central BP target
Participants randomized to central BP target will be treated with anti-hypertensive agents to achieve a clinic central SBP < 130 mmHg.
Other: Central vs brachial systolic blood pressure targeting
Participants will be randomized to either a central BP target (intervention) or a brachial BP target (standard care). For each group, the source of the BP (central or brachial) will be blinded and only the BP values will be provided to the attending Nephrologist. In both cases, the target SBP will be <130 mmHg.

Active Comparator: Brachial BP target (standard of care)
Participants randomized to a brachial BP target will be treated with anti-hypertensive drugs to achieve a clinic brachial SBP <130 mmHg.
Other: Central vs brachial systolic blood pressure targeting
Participants will be randomized to either a central BP target (intervention) or a brachial BP target (standard care). For each group, the source of the BP (central or brachial) will be blinded and only the BP values will be provided to the attending Nephrologist. In both cases, the target SBP will be <130 mmHg.




Primary Outcome Measures :
  1. Feasibility: Consent rate [ Time Frame: Baseline ]

    Proportion of participants who provide consent relative to the number approached for participation.

    Feasibility criteria (No / Probable / Yes): <30% / 30-60% / >60%


  2. Feasibility: Recruitment rate [ Time Frame: Baseline ]

    Proportion of randomized participants relative to the number of screened participants.

    Feasibility criteria (No / Probable / Yes): <40% / 40-80% / >80%


  3. Feasibility: Achieved BP target rate [ Time Frame: 12 months ]
    Proportion of randomized participants who achieve BP target at 12 months Feasibility criteria (No / Probable / Yes): <30% / 30-60% / >60%

  4. Feasibility: Completion rate [ Time Frame: 12 months ]
    Proportion of randomized participants who complete the trial Feasibility criteria (No / Probable / Yes): <40% / 40-80% / >80%

  5. Feasibility: Recruitment pace [ Time Frame: 12 months after activation of last site ]
    Number of participants recruited after 24 months of activation for all sites Feasibility criteria (No / Probable / Yes): <54 / 54-81 / >81

  6. Feasibility: Divergent treatment decision rate [ Time Frame: 12 months ]
    Proportion of divergent treatment decision based on central BP compared to brachial BP Feasibility criteria (No / Probable / Yes): <10% / 10-30% / >30%

  7. Feasibility: Therapeutic inertia rate [ Time Frame: 12 months ]
    Proportion of therapeutic inertia Feasibility criteria (No / Probable / Yes): >60% / 60-30% / <30%

  8. Difference in aortic stiffness [ Time Frame: 12 months ]
    Carotid-femoral pulse wave velocity


Secondary Outcome Measures :
  1. Difference in eGFR decline [ Time Frame: 12 months ]
  2. Change in albuminuria [ Time Frame: 12 months ]
  3. Difference in Daily Defined Doses of blood pressure drugs [ Time Frame: 12 months ]
  4. Quality of life (KDQOL-SF questionnaire) [ Time Frame: 12 months ]
    Score 0 to 100. Higher score represents better quality of life


Other Outcome Measures:
  1. Progression towards kidney failure (sustained eGFR loss ≥ 40%, kidney replacement therapy initiation or death from renal failure) [ Time Frame: 12 months ]
  2. Major adverse cardiovascular adverse events (cardiovascular mortality, myocardial infarction, stroke, heart failure requiring hospitalisation, peripheral artery disease requiring revascularisation or amputation) [ Time Frame: 12 months ]
    Composite and individuals outcomes

  3. All-cause hospitalisation [ Time Frame: 12 months ]
  4. All-cause mortality [ Time Frame: 12 months ]
  5. Acute kidney injury (>50% increase in serum creatinine) [ Time Frame: 12 months ]
  6. Symptomatic orthostatic hypotension, dizziness, light headedness, injurious falls, syncope or any unexpected event attributable to the intervention [ Time Frame: 12 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Over 18 years of age;
  2. eGFR <30 mL/min/1.73m2 as determined by the CKD-EPI equation (within 30 days of screening);
  3. Office brachial cuff systolic blood pressure between 120 and 160 mmHg (using automated office blood pressure).

Exclusion Criteria:

  1. Already taking 5 or more anti-hypertensive medications (any class)
  2. Unwillingness to change anti-hypertensive medication by the attending Nephrologist or patient
  3. Recent acute kidney injury (>50% increase in serum creatinine in preceding 30 days)
  4. Previous kidney replacement therapy (kidney transplant, hemodialysis or peritoneal dialysis)
  5. Recent myocardial infarction, stroke, heart failure (in preceding 30 days)
  6. Recent injurious fall requiring hospitalisation (in preceding 30 days)
  7. Concomitant major illness / comorbidity that may result in death in the next 6 months
  8. Participation in another study that is likely to affect BP levels
  9. Inability to provide consent due to cognitive impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05163158


Contacts
Layout table for location contacts
Contact: Guylaine Marcotte 1(514)338-2222 ext 3182 guylaine.marcotte@cnmtl.gouv.qc.ca

Locations
Layout table for location information
Canada, Quebec
Hôpital du Sacré-Coeur de Montréal Recruiting
Montréal, Quebec, Canada, H4J1C5
Contact: Guylaine Marcotte         
Principal Investigator: Remi Goupil, MD MSc         
Sponsors and Collaborators
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Investigators
Layout table for investigator information
Principal Investigator: Remi Goupil, MD MSc Hôpital Sacré-Coeur de Montréal
Layout table for additonal information
Responsible Party: Remi Goupil, MD MSc, Principal Investigator, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
ClinicalTrials.gov Identifier: NCT05163158    
Other Study ID Numbers: CENTRAL-CKD Protocol Version 1
First Posted: December 20, 2021    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Remi Goupil, MD MSc, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal:
Central blood pressure
Central hypertension
Chronic kidney disease
Hypertension
Arterial stiffness
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Renal Insufficiency, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency