1. Felix Mahfoud Saarland University Hospital, Homburg, Germany
CRT 2017
What Are the Primary Endpoints for Controlling Hypertension? Unattended or Attended Office, Ambulatory or Home BP?
Felix Mahfoud
Saarland University Hospital, Homburg, Germany

2. Disclosure Statement of Financial Interest
I have the following potential conflicts of interest to report:
Research grants:
Deutsche Hochdruckliga
Deutsche Gesellschaft für Kardiologie
Saarländisches Ministerium für Wissenschaft und Forschung
Medtronic, St. Jude
Consultant/Lecture fee:

3. Office attended non-automated BP
Home BP
Office automated unattended BP
Office automated attended BP
24-h Ambulatory BP

4. SPRINT - Reduction in endpoints
Intensive (121 mmHg) vs. standard treatment (135 mmHg)
Cardiovascular death: - 43%
Overall mortality: -27%
Heart failure: -38%

5. Blood pressure measurements in SPRINT

6. Blood pressure measurements in SPRINTX

7. Blood pressure measurements in SPRINT

8. Blood pressure measurement in perspective
SBP by automated office BP monitors is comparable to daytime ambulatory
10-15 mmHg lower compared to (attended) office BP
Kjeldsen SE, Hypertension 2016

9. Blood pressure measurement in perspective
SBP by automated office BP monitors is comparable to daytime ambulatory
10-15 mmHg lower compared to (attended) office BP
Kjeldsen SE, Hypertension 2016

10. Data from 897 SPRINT patients at 27-month FU
Intensive treatment, n=453 BP
Unattended
120 mmHg
Daytime
126 mmHg
24-hour
123 mmHg
Drawz PE, Hypertension 2017

11. Data from 897 SPRINT patients at 27-month FU
Intensive treatment, n=453 BP
Unattended
120 mmHg
Daytime
126 mmHg
24-hour
123 mmHg
Standard treatment, n=444 BP
Unattended
136 mmHg
Daytime
139 mmHg
24-hour
134 mmHg
Drawz PE, Hypertension 2017

12. Correlation between clinic and ABP in other hypertension trials
24-hour SBP (mmHg)
134
123
Clinic BP (mmHg)
132
152
Parati G, Hypertension 2017

13. ABP versus office BP Advantages of ABPM
Provides more precise BP profiles
Ability to determine BP during sleep
Identification of the white-coat effect
Detection of masked hypertension
Improved reproducibility
Can be easily blinded

14. ABP versus office BP Disadvantages of ABPM Costs Discomfort/reluctancy
No real-time blood pressure assesment
Lack of evidence-based recommendations for target BP based on ambulatory values

15. Correlation in ABPM and office BP reductions – data from drug trials
Mancia G, J Hypertension 2004

16. Schmieder RE, Hypertension 2014

17. REDUCE-HTN: REINFORCE Study
24-hour ABP
Daytime ABP
REDUCE-HTN: REINFORCE Study
24-hour ABP
24-hour ABP
24-hour ABP

18. Clinical Consensus Conference on Device-based Therapies for Hypertension Part II
As target BP in a clinical trial of device-based therapy in hypertension, the European Expert Group recommended an attended target seated office BP <140 mmHg using the conventional method and a validated device. Whichever method is used, it is critical that consistency is maintained in all centres and at all visits.

19. Clinical Consensus Conference on Device-based Therapies for Hypertension Part II
Considering the less well established standardization of home compared with ABPM, the European Expert Group does not recommend using home BP measurement as a primary endpoint in clinical trials, while there is large agreement that it can be used as a secondary endpoint. Furthermore, in device trials home BP monitoring may conceivably influence adherence.

20. What needs to be discussed for future device-based hypertension trials?
Inclusion criteria
Office BP >140 mmHg?
24-hour BP >135 mmHg?
Daytime BP >135 mmHg?

21. What needs to be discussed for future device-based hypertension trials?
Inclusion criteria
Office BP >140 mmHg?
24-hour BP >130 mmHg?
Daytime BP >135 mmHg?
Clinical meaningful BP reduction
Office BP change >10 mmHg?
24-hour BP change >5 mmHg?
Daytime BP change >5 mmHg?

22. Thank you! Felix Mahfoud, MD FESC Klinik für Innere Medizin III
Kardiologie, Angiologie und Intern. Intensivmedizin
Universitätsklinikum des Saarlandes
Homburg/Saar