SyncopeSynABPMNCT05729724
Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)
An observational study of Syncope and Syncope, Vasovagal, run by Istituto Auxologico Italiano at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Syncope, Vasovagal, Ambulatory Blood Pressure Monitoring
- How many people
- 111 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2022to 31 Jul 2023
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Keywords
- Syncope, Tilt testing, Carotid sinus massage, 24-hour ABPM
- Medical subject headings
- Syncope, Syncope, Vasovagal, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation
Correlation between changes in 24-hour average SBP and burden of SBP drops
Measured: two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start5 Oct 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele Brignole, MD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729724
- Sponsor's protocol ID
- 09C216
- Acronym
- SynABPM
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request
Publications
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.
PubMed 35766175Groppelli 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.
PubMed 38262617
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05729724
- Acronym / sponsor ID
- SynABPM / 09C216
- Conditions
- Syncope, Syncope, Vasovagal, Ambulatory Blood Pressure Monitoring, Antihypertensive Drugs, Orthostatic Hypotension
- Keywords
- Syncope, Tilt testing, Carotid sinus massage, 24-hour ABPM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation
Time frame: two months
Correlation between changes in 24-hour average SBP and burden of SBP drops
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 35766175Rivasi 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.
- Derived from this study: PubMed 38262617Groppelli 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.
- Individual participant dataSharing planned: Yes. Upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Brignole, MD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Syncope, Vasovagal, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation (time frame: two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05729724, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.