NCT05529147: BLUEBERRY

The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly

Completed Last updated 5 June 2024

What this trial tests

trial testing Antihypertensive Agents in Hypertension in 15 participants. Completed in 18 July 2023.

Timeline

5 September 2022

Primary endpoint
18 July 2023

18 July 2023

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Completed
Study type	OBSERVATIONAL
Enrollment	15
Start date	5 September 2022
Primary completion	18 July 2023
Estimated completion	18 July 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Antihypertensive Agents — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →
• Frailty — all drugs for Frailty →
• Old Age; Dementia — all drugs for Old Age; Dementia →
• Orthostatic Intolerance — all drugs for Orthostatic Intolerance →

Sponsor

Radboud University Medical Center

Who can join

70 and older, any sex, with Hypertension or Frailty. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale: Systolic hypertension represents the leading risk for burden of disease among older adults (age \>70 years), with an increasing prevalence due to the increase in lifespan. Antihypertensive drug treatment (AHT) is beneficial in fit (non-frail) older adults, with substantial (≈40 %) risk reductions for cardiovascular events and mortality. Scarce evidence exists on the risks of adverse effects related to AHT. It has been suggested in medical literature that AHT in frail elderly might cause cerebral hypoperfusion and/or orthostatic hypotension. Therefore, current guidelines advise clinicians to be more cautious regarding treatment targets in this population. However, the evidence for these adverse effects is limited to observational and cross-sectional data and opinion pieces. In contrast to the suggestion of potential adverse effects of AHT in elderly, recent experimental data and secondary analyses of clinical trials do not provide support for this statement. However, evidence in frail older patients remains scarce. Studies that directly examine the safety of AHT with regard to cerebral hemodynamics and orthostatic tolerance in frail elderly are needed to inform potential changes in current treatment guidelines and prevent undertreatment of hypertension in frail older patients.

Objective: To examine the impact of medication induced systolic BP (SBP) reductions ≥10 mmHg, while reaching a treatment target of ≤140 mmHg, on cerebral blood flow (CBF) in frail elderly with untreated or uncontrolled systolic hypertension at baseline. We hypothesise that these blood pressure lowering targets (which are consistent with clinical guidelines for non-frail older patients) are not accompanied by detrimental reductions in CBF (i.e. \>10% from baseline).

Study design: An explorative observational study will be performed to examine the effects of medication induced SBP reductions ≥10 mmHg to office SBP ≤140 mmHg on CBF in frail elderly with untreated or uncontrolled hypertension. Participants will be treated as in usual patient care for older adults with hypertension. Participants will undergo one baseline assessment before exposure to (additional) AHT, followed by in duplo follow-up assessments 6-10 weeks after the start of AHT. The in duplo follow-up evaluations will be performed on separate days within 2 weeks while continuing treatment.

Study population: Twelve frail (Clinical Frailty Scale 4-7) elderly (age ≥70 years) with untreated or uncontrolled systolic hypertension (office SBP ≥150 mmHg) that will be subjected to (additional) AHT as part of regular care.

Main study parameters/endpoints: The change in resting CBF from baseline to follow-up (i.e. the average of the in duplo follow-up assessments). Secondary outcomes relate to cerebrovascular autoregulation (CA) and orthostatic tolerance.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will be subjected to AHT, essentially identical to what is considered 'guideline care', while their wellbeing will be monitored closely. Since all study procedures and used measurement techniques are non-invasive, the nature and extent of burden and risks associated with participation and measurements are negligible.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.