Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02268071
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2014-10-14
Brief Title:
Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care STOP-Trial
Sponsor:
Central Hospital Nancy France
Organization:
Central Hospital Nancy France
Study Overview
Official Title:
Arrêt du Traitement Antihypertenseur Chez Les Patients Hypertendus Suivis en Médecine Générale Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care The STOP-Trial
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The STOP-Trial is a prospective multicenter nonrandomized open study on grade I hypertension performed by General practitioners
The study will be conducted in parallel in the Clinical Investigation Center Plurithematic CIC-P1433 of Nancy the study coordinating center by the general practitioners investigators of the CIC-P
The main purpose of the study is to determine the factors associated with the rate of patients remaining normotensive one year after stopping their antihypertensive monotherapy or low dose dual therapy
white coat hypertension
primary diagnosis by home blood pressure measurements HBPM ambulatory blood pressure measurements ABPM clinical measure
initial blood pressure level
compliance
therapeutic class versus others
age
gender
weight variation
modification of lifestyle
concomitant treatments and associated substances
The primary endpoint will be the rate of normotensive patients at one year ie HBPM values 13585 mmHg
The study will be conducted in parallel in the Clinical Investigation Center Plurithematic CIC-P1433 of Nancy the study coordinating center by the general practitioners investigators of the CIC-P
The main purpose of the study is to determine the factors associated with the rate of patients remaining normotensive one year after stopping their antihypertensive monotherapy or low dose dual therapy
white coat hypertension
primary diagnosis by home blood pressure measurements HBPM ambulatory blood pressure measurements ABPM clinical measure
initial blood pressure level
compliance
therapeutic class versus others
age
gender
weight variation
modification of lifestyle
concomitant treatments and associated substances
The primary endpoint will be the rate of normotensive patients at one year ie HBPM values 13585 mmHg
Detailed Description:
HBPM should be performed by the patients twice a day for 7 consecutive days before each visit ESH protocol using a device clinically tested ESHinternational protocol
At baseline visit 1 for the patients included the antihypertensive treatment will be stopped in 3 consecutive days half dose then interruption over a maximum period of 12 months corresponding to the length of the participation and the monitoring of the patients
Follow-up visits at day 30 visit 2 day 90 visit 3 day 180 visit 4 day 270 visit 5 and day 360 visit 6 Will be performed at each visit
Calculation of the average of HBPM values by the investigator
Measurements of office blood pressure average of 3 consecutive measurements
SF 36 scale at baseline visit 1 and day 360 visit 6
During follow-up the investigator will be free at any time to reintroduce an antihypertensive treatment if the average of HBPM values is greater than or equal to 13585 mmHg on two consecutive visits or greater than or equal to 15595 mmHg regardless of the visit and regardless of the office blood pressure level
At the end of study the recovery of an antihypertensive treatment by the patients will be left to the discretion of the investigator
At baseline visit 1 for the patients included the antihypertensive treatment will be stopped in 3 consecutive days half dose then interruption over a maximum period of 12 months corresponding to the length of the participation and the monitoring of the patients
Follow-up visits at day 30 visit 2 day 90 visit 3 day 180 visit 4 day 270 visit 5 and day 360 visit 6 Will be performed at each visit
Calculation of the average of HBPM values by the investigator
Measurements of office blood pressure average of 3 consecutive measurements
SF 36 scale at baseline visit 1 and day 360 visit 6
During follow-up the investigator will be free at any time to reintroduce an antihypertensive treatment if the average of HBPM values is greater than or equal to 13585 mmHg on two consecutive visits or greater than or equal to 15595 mmHg regardless of the visit and regardless of the office blood pressure level
At the end of study the recovery of an antihypertensive treatment by the patients will be left to the discretion of the investigator
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