Clinical Trial: Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care (STOP-Trial)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Arrêt du Traitement Antihypertenseur Chez Les Patients Hypertendus Suivis en Médecine Générale / Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care: Th

Brief Summary:

The STOP-Trial is a prospective multicenter nonrandomized open study on grade I hypertension, performed by General Practitioners.

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 (i.e. HBPM values <135/85 mmHg).


Detailed Summary:

HBPM should be performed by the patients twice a day for 7 consecutive days before each visit (ESH protocol), using a device clinically tested (ESH/international 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 135/85 mmHg on two consecutive visits, or greater than or equal to 155/95 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.


Sponsor: Central Hospital, Nancy, France

Current Primary Outcome: The rate of normotensive patients at 1 year (i.e HBPM <135/85 mmHg) [ Time Frame: At 12 months after antihypertensive treatment interruption ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The rate of normotensive patients at 3 months (i.e HBPM <135/85 mmHg) [ Time Frame: At 3 months after antihypertensive treatment interruption ]
  • The rate of normotensive patients at 6 months (i.e HBPM <135/85 mmHg) [ Time Frame: At 6 months after antihypertensive treatment interruption ]
  • The rate of normotensive patients at 9 months (i.e HBPM <135/85 mmHg) [ Time Frame: At 9 months after antihypertensive treatment interruption ]
  • Evolution of the quality of life scale (part of SF36) [ Time Frame: Change from baseline to 12 months after antihypertensive treatment interruption ]


Original Secondary Outcome: Same as current

Information By: Central Hospital, Nancy, France

Dates:
Date Received: October 14, 2014
Date Started: November 2014
Date Completion: November 2017
Last Updated: October 14, 2014
Last Verified: October 2014