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Diurnal BP Patterns in Those at Increased Risk of CVD

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria expanded, about 5 words
  2. Notable Primary completion date: Aug 31, 2025 to Dec 31, 2026 Completion date: Dec 31, 2025 to Dec 31, 2026v7 Show 1 more changeShow less
    • Completion date: Dec 31, 2025 to Dec 31, 2026
  3. Notable Primary completion date: Aug 1, 2024 to Aug 31, 2025 Completion date: Mar 31, 2025 to Dec 31, 2025v6 Show 1 more changeShow less
    • Completion date: Mar 31, 2025 to Dec 31, 2025
  4. Minor Completion date: Aug 1, 2024 to Mar 31, 2025v5
  5. Notable Primary and study completion dates: Aug 1, 2023 to Aug 1, 2024v4
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  1. Notable Primary and study completion dates: Feb 1, 2022 to Aug 1, 2023v3
  2. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In health, blood pressure (BP) falls at night by \>10% compared with day-time values. This natural dipping pattern is important as without it there is an increased risk of cardiovascular disease (CVD). Recent evidence suggests that chronotherapy (taking anti-hypertensive medication at bedtime instead of in the morning) may enhance nocturnal BP dipping and reduce the risk of CVD events. There is therefore an urgent need to characterise diurnal BP patterns in patients who may be at risk of reduced nocturnal dipping in order to maximise protective therapy in all those who would benefit. Similarly, it has previously been demonstrated that increased arterial stiffness is associated with increased CVD risk, however little is known about whether loss of diurnal variations in arterial stiffness confer addition risk. Kidney disease is independently associated with increased CVD events, but the exact makeup of this risk is not clear. Within this heterogenous cohort several very distinct groups exist including those with acute kidney injury (AKI), chronic kidney disease (CKD), inflammatory conditions like small vessel vasculitis (SVV), and those who have either donated or received a kidney transplant. Diurnal BP and arterial stiffness patterns within these patient groups are not well characterised. The investigators will recruit patients at increased risk of CVD from the Royal Infirmary of Edinburgh Renal and Vasculitis Clinics. Participants will undergo 24-hour ambulatory BP and arterial stiffness measurement in conjunction with day- and night-time blood and urine sampling on two separate occasions. This study aims to characterise diurnal patterns of BP and arterial stiffness in patients at increased risk of CVD and compare findings with healthy controls. In doing so, the investigators aim to allow more targeted CVD risk reduction strategies and improve long-term patient outcomes.
Trial Details
NCT Number NCT04522765
Lead Sponsor University of Edinburgh
Conditions Cardiovascular Risk Factor, Blood Pressure, Arterial Stiffness, Chronic Kidney Diseases
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov