Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513650
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Mechanism-based Therapy of Hypotensive Syncope
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mechanism-based Therapy of Hypotensive Syncope
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
2STEPtherapy
Brief Summary:
The aim of this study is to assess the efficacy of a therapeutic strategy aimed to increase 24-hour systolic blood pressure SBP values assessed by 24-hour ambulatory blood pressure monitoring ABPM in reducing syncope recurrences in patients affected by hypotensive syncope during one year of follow-up
Detailed Description:
This multicentre prospective observational pragmatic study on long-term therapy of hypotensive syncope consists of two distinct twin substudies to be undergone in parallel
1 the Drug-deprescribing substudy wants to assess a strategy aimed to increase BP by deprescribing of hypotensive drugs in hypertensive patients affected by drug-related syncope and
2 the Drug-addition substudy wants to assess a therapeutic strategy aimed at increasing BP with fludrocortisone in syncopal patients with drug-unrelated permanent or intermittent hypotension
Inclusion criteria
1 Patients gt18-year-old with a clinical diagnosis of severe recurrent reflex syncope refractory to education and life-style measures according to the criteria of ESC guidelines AND a diagnosis of hypotensive syncope defined as
Persistent or intermittent hypotension during 24-hour ABPM ABPM1 ANDOR
Reproduction of syncope during the Short Cardiovascular Autonomic Function Assessment SCAFA that consists in carotid sinus massage CSM 3-min active stand test and head-up tilt test TT performed one after another in an uninterrupted sequence as a single procedure in a tilt table
2 Clinical indication to deprescribing of antihypertensive drugs or to prescribing of fludrocortisone therapy as appropriate according to the clinical practice of the investigator Exclusion criteria
1 Age lt18 years 2 Cardioinhibitory reflex syncope during SCAFA tests 3 Competing causes of syncope 4 Severe cardiac disease previous stroke or transient ischaemic attack 5 Patients who refused drug therapy 6 Non-severe forms of syncope ie patients with rare and mild episodes occurring in low-risk situations in the presence of distinct and preventable triggers
7 Contraindication to fludrocortisone Therapy The strategy of deprescribing withdrawal or dose reduction is empirically based on the usual clinical practice of the investigators and is targeted to achieve an absolute value 134 mmHg andor an increase 12 mmHg of 24-hour SBP
The initial recommended dose of fludrocortisone is 02 mdday accepted range is 01 to 03 mg and is targeted to achieve an absolute value of 116 mmHg andor an increase of 9 mmHg of 24-hour SBP
30-day optimization period A period up to 30 days is allowed to optimize therapy if necessary with the goal to achieve the above targets of mean 24-hour SBP during an ABPM performed at the end of this period ABPM2 Subsequent follow-up visits are performed at 4 8 and 12 months
Primary endpoints
The primary endpoint of the Drug-deprescribing subgroup is the comparison of syncopal recurrences time to first recurrence and syncope burden at one year in patients who achieved a mean absolute value of 134 mmHg andor an increase 12 mmHg of 24-hour SBP on ABPM2 Target with those of patients who did not No target
The primary endpoint of the Drug-addition subgroup is the comparison of syncopal recurrences time to first recurrence and syncope burden at one year in patients who achieved a mean absolute value of 116 mmHg and an increase of 9 mmHg of 24-hour SBP on ABPM2 Target with those of patients who did not No target
Secondary endpoints
Comparison between the burden of syncope and presyncope during the year before with that during the year after enrolment
Exploratory analyses with the aim to identify eventual different targets that are better predictor of efficacy of therapy
1 the Drug-deprescribing substudy wants to assess a strategy aimed to increase BP by deprescribing of hypotensive drugs in hypertensive patients affected by drug-related syncope and
2 the Drug-addition substudy wants to assess a therapeutic strategy aimed at increasing BP with fludrocortisone in syncopal patients with drug-unrelated permanent or intermittent hypotension
Inclusion criteria
1 Patients gt18-year-old with a clinical diagnosis of severe recurrent reflex syncope refractory to education and life-style measures according to the criteria of ESC guidelines AND a diagnosis of hypotensive syncope defined as
Persistent or intermittent hypotension during 24-hour ABPM ABPM1 ANDOR
Reproduction of syncope during the Short Cardiovascular Autonomic Function Assessment SCAFA that consists in carotid sinus massage CSM 3-min active stand test and head-up tilt test TT performed one after another in an uninterrupted sequence as a single procedure in a tilt table
2 Clinical indication to deprescribing of antihypertensive drugs or to prescribing of fludrocortisone therapy as appropriate according to the clinical practice of the investigator Exclusion criteria
1 Age lt18 years 2 Cardioinhibitory reflex syncope during SCAFA tests 3 Competing causes of syncope 4 Severe cardiac disease previous stroke or transient ischaemic attack 5 Patients who refused drug therapy 6 Non-severe forms of syncope ie patients with rare and mild episodes occurring in low-risk situations in the presence of distinct and preventable triggers
7 Contraindication to fludrocortisone Therapy The strategy of deprescribing withdrawal or dose reduction is empirically based on the usual clinical practice of the investigators and is targeted to achieve an absolute value 134 mmHg andor an increase 12 mmHg of 24-hour SBP
The initial recommended dose of fludrocortisone is 02 mdday accepted range is 01 to 03 mg and is targeted to achieve an absolute value of 116 mmHg andor an increase of 9 mmHg of 24-hour SBP
30-day optimization period A period up to 30 days is allowed to optimize therapy if necessary with the goal to achieve the above targets of mean 24-hour SBP during an ABPM performed at the end of this period ABPM2 Subsequent follow-up visits are performed at 4 8 and 12 months
Primary endpoints
The primary endpoint of the Drug-deprescribing subgroup is the comparison of syncopal recurrences time to first recurrence and syncope burden at one year in patients who achieved a mean absolute value of 134 mmHg andor an increase 12 mmHg of 24-hour SBP on ABPM2 Target with those of patients who did not No target
The primary endpoint of the Drug-addition subgroup is the comparison of syncopal recurrences time to first recurrence and syncope burden at one year in patients who achieved a mean absolute value of 116 mmHg and an increase of 9 mmHg of 24-hour SBP on ABPM2 Target with those of patients who did not No target
Secondary endpoints
Comparison between the burden of syncope and presyncope during the year before with that during the year after enrolment
Exploratory analyses with the aim to identify eventual different targets that are better predictor of efficacy of therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None