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

NCT05729724 | Completed

• 1 other identifier: 09C216
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Syncope; Tilt testing; Carotid sinus massage; 24-hour ABPM

Outcome Measures

Primary Outcomes (1)

• Correlation

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

  two months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Milan, MI, 16149, Italy

Location

Related Publications (2)

• 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.

  PMID: 35766175 BACKGROUND

• 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.

  PMID: 38262617 DERIVED

MeSH Terms

Conditions

Syncope; Syncope, Vasovagal; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michele Brignole, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: October 5, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of the study
• Access Criteria: mbrignole@outlook.it

Locations

IT (1)