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

Syncope Clinical Trial

— SynABPM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05729724
• Other study ID #: 09C216
• Status: Completed
• Start date: October 5, 2022
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2024
• Source: Istituto Auxologico Italiano
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Blood Pressure Monitoring
• Antihypertensive Drugs
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Syncope
• Syncope, Vasovagal

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano	Milan	MI

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Rivasi G, Groppelli A, Brignole M, Soranna D, Zambon A, Bilo G, Pengo M, Sharad B, Hamrefors V, Rafanelli M, Testa GD, Rice C, Kenny RA, Sutton R, Ungar A, Fedorowski A, Parati G. Association between hypotension during 24 h ambulatory blood pressure monitoring and reflex syncope: the SynABPM 1 study. Eur Heart J. 2022 Oct 11;43(38):3765-3776. doi: 10.1093/eurheartj/ehac347. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation	Correlation between changes in 24-hour average SBP and burden of SBP drops	two months