The effects of medication induced blood pressure reduction on cerebral hemodynamics in hypertensive frail elderly

Recruiting

Conditions: high blood pressure
hypertension
10057166

Registration Number: NL-OMON51539

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

- Age >=70 years.
- Clinical Frailty Scale >=4 and <=7.
- Diagnosis of:
• Untreated systolic hypertension, i.e. office systolic blood pressure >=150
mmHg without antihypertensive treatment, or;
• Uncontrolled systolic hypertension, i.e. office systolic blood pressure >=150
mmHg despite antihypertensive treatment.
- Will be starting (untreated) or adding (uncontrolled) antihypertensive
treatment in the near future for (further) reducing systolic blood pressure by
>=10 mmHg while reaching a treatment target of office systolic blood pressure
<=140 mmHg, with the indication of primary or secondary prevention of vascular
events, judged by the treating physician (geriatrician or primary care
physician)
- Able to understand and perform study related procedures.

Exclusion Criteria

- Unable to provide signed and dated informed consent form.
- Mentally incompetent subjects (e.g. due to dementia) as assessed by a
physician.
- Currently enrolled in another interventional study targeting either blood
pressure and/or cerebral blood flow.
- Cardiovascular event within the past 3 months.
- Severe renal disease (eGFR <40 ml/min).
- Known secondary cause of hypertension that causes safety concerns.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The change in resting CBF from baseline to follow-up (i.e. the average of the<br /><br>in duplo follow-up assessments). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The change in orthostatic tolerance and measures of cerebral autoregulation,<br /><br>i.e. dynamic cerebral autoregulation and baroreflex sensitivity, from baseline<br /><br>to follow-up (i.e. the average of the in duplo follow-up assessments).<br /><br>- The number/percentage of patients that demonstrate a >10% decrease in CBF<br /><br>from baseline to follow-up.<br /><br>- In addition to (reductions in) mean CBF, the number and duration of episodes<br /><br>(during continuous monitoring of CBF) where CBF is reduced by >10% from the<br /><br>mean baseline value.</p><br>