Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-conc… (NCT05729724) | Clinical Trial Compass
CompletedNot Applicable
Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)
Italy111 participantsStarted 2022-10-05
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Eligible patients were those who fulfilled all the following criteria:
* had received a diagnosis of reflex syncope
* had undergone an ABPM as part of the routine work-up of syncope in use in these hospitals that had shown one or more daytime SBP drop \<90 mmHg or one or more daytime drops \<100 mmHg in patients with average 24-hour SBP ≥125 mmHg
* had received instructions in order to abolish/reduce their antihypertensive therapy with the aim to prevent syncopal recurrences or had received active drug therapy, i.e., fludrocortisone, in order to increase their arterial blood pressure.
* had performed a second ABPM within 6 months from ABPM 1 in order to verify the effect of the prescribed change in therapy
Exclusion Criteria:
* Age \<18 years
* Symptomatic orthostatic hypotension (defined as a symptomatic fall in SBP ≥20 mm Hg or a SBP decrease to \<90 mmHg, as per the ESC guidelines;
* competing causes of syncope (i.e., syncope due to arrhythmias and structural cardiac diseases and non-syncopal causes of transient loss of consciousness as defined by ESC guidelines on syncope
* Severe structural heart disease, previous stroke or transient ischaemic attack