The effects of blood pressure lowering on cerebral blood flow in older adults with high blood pressure

Phase 1

• Conditions: Hypertension; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2022-001283-10-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-18
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

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 <25 ml/min).
- Known secondary cause of hypertension that causes safety concerns.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the impact of medication induced systolic blood pressure reductions =10 mmHg to reach a treatment target of 140 mmHg, as part of regular care, on cerebral blood flow in frail elderly with untreated or uncontrolled systolic hypertension (i.e. office systolic blood pressure =150 mmHg) at baseline.;Secondary Objective: To examine the effects of medication induced systolic blood pressure reductions on orthostatic tolerance and measures of cerebrovascular autoregulation, i.e. dynamic cerebral autoregulation and baroreceptor reflex sensitivity, in frail elderly with systolic hypertension.;Primary end point(s): Resting cerebral blood flow;Timepoint(s) of evaluation of this end point: At baseline (before the start of treatement) and during two follow-up assessments on seperate days after 6-10 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Orthostatic tolerance, dynamic cerebral autoregulation and baroreceptor reflex sensitivity.;Timepoint(s) of evaluation of this end point: At baseline (before the start of treatement) and during two follow-up assessments on seperate days after 6-10 weeks of treatment.