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

NCT ID: NCT05729724

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 111 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2023-07-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Change treatment

Deprescribing (patients on hypotensive medications): withdrawal or reduction of one or more medications among cardiovascular and psychoactive drugs with known hypotensive effects (Table) Prescription of vasoactive medications (patients with constitutional hypotension): prescription of Fludrocortisone or other drugs that actively increase blood pressure.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Auxologico Italiano

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Brignole, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

IRCCS Istituto Auxologico Italiano

Milan, MI, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 35766175 (View on PubMed)

Groppelli A, Rivasi G, Fedorowski A, de Lange FJ, Russo V, Maggi R, Capacci M, Nawaz S, Comune A, Bianchi L, Zambon A, Soranna D, Ungar A, Parati G, Brignole M. Interventions aimed to increase average 24-h systolic blood pressure reduce blood pressure drops in patients with reflex syncope and orthostatic intolerance. Europace. 2024 Feb 1;26(2):euae026. doi: 10.1093/europace/euae026.

Reference Type: DERIVED

PMID: 38262617 (View on PubMed)

Other Identifiers

09C216

Identifier Type: -

Identifier Source: org_study_id