Study on Blood Pressure Variability and Frailty in the Older People
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age75+
SponsorIstituto Auxologico Italiano
About this trial
Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \<90 mmHg (or two episodes of daytime SBP \<90 mmHg, if mean 24 h SBP is \<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 75 years
Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines [Williams 2018]
Consent of the patient (or legal representative) to participate in the study
Disqualifiers
Refusal of the patient or his/her legal representative
Life expectancy of less than 6 months
Trial population
Elderly hypertensive patients who are enrolled at the Hypertension Centre of Istituto Auxologico italiano IRCCS
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Diagnostic tests and questionnaires
Diagnostic testAssessment of office blood pressure, orthostatic hypotension, 24-hour ambulatory blood pressure, frailty
Treatment groups
220 Participants
are divided into 1 treatment groupGroup A: Patients with hypertension, aged 75 years and older1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events
Adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)
Time frame
At 24 months of follow-up2
Prevalence of hypotensive phenotype
Hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \<90 mmHg (or two episodes of daytime SBP \<90 mmHg, if mean 24 h SBP is \<125 mmHg)
Time frame
At baselineSponsors and contacts
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Source ClinicalTrials.gov