Trials / Completed
CompletedNCT05729724
Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)
Effect of Pharmacological Interventions Aimed to Increase Arterial Blood Pressure on Systolic Blood Pressure Drops Evidenced by 24-hour Ambulatory Blood Pressure Monitoring in Patients With Reflex Syncope
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 111 (actual)
- Sponsor
- Istituto Auxologico Italiano · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
SynABPM 2 proof-of-efficacy is a retrospective, multicentre, observational study performed in patients affected by hypotensive reflex syncope who had performed two ABPMs, one before and another after any therapeutical intervention aimed to increase arterial blood pressure
Detailed description
24-hour ambulatory blood pressure monitoring (ABPM) is able to detect systolic blood pressure (SBP) drops that allow to discriminate patients with reflex syncope from controls. One episode of daytime SBP \<90 mmHg or one episode of daytime SBP \<100 mmHg, if mean 24-hour SBP is \<125 mmHg, is the best cut-off for the identification of reflex syncope patients with hypotensive susceptibility. The hypothesis of the present proof-of-concept study is that a therapeutic strategy aimed to increase arterial blood pressure can prevent SBP drops and (hopefully) reduce syncope recurrences. If the study hypothesis will be confirmed, the magnitude of increase of SBP needed to abolish SBP drops will be also assessed.
Conditions
- Syncope
- Syncope, Vasovagal
- Ambulatory Blood Pressure Monitoring
- Antihypertensive Drugs
- Orthostatic Hypotension
Timeline
- Start date
- 2022-10-05
- Primary completion
- 2023-07-31
- Completion
- 2023-07-31
- First posted
- 2023-02-15
- Last updated
- 2024-02-20
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05729724. Inclusion in this directory is not an endorsement.