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Completed

NCT Number: NCT05729724

Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)

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

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation

    Time frame: two months

    Correlation between changes in 24-hour average SBP and burden of SBP drops

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: SynABPM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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