Trial Outcomes & Findings for Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study (NCT NCT02121041)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

Participants will be on study average of 4 months.

Results posted on

2017-02-10

Participant milestones
Measure	Usual Care Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.	ABPM Guided Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan. Amlodipine: Amlodipine 5 mg or 10 mg Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg Losartan: Losartan 50 mg or 100 mg
Overall Study STARTED	14	14
Overall Study COMPLETED	13	8
Overall Study NOT COMPLETED	1	6

Withdrawal data not reported

Ambulatory vs Office BP Management Usual Care for Diagnosing and Managing Hypertension: A Pilot Study

Baseline characteristics by cohort
Measure	Usual Care n=14 Participants Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.	ABPM Guided n=14 Participants Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan. Amlodipine: Amlodipine 5 mg or 10 mg Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg Losartan: Losartan 50 mg or 100 mg	Total n=28 Participants Total of all reporting groups
Age, Customized	47.6 years STANDARD_DEVIATION 12 • n=5 Participants	49.2 years STANDARD_DEVIATION 10 • n=7 Participants	48.4 years STANDARD_DEVIATION 11 • n=5 Participants
Gender Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Gender Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants

Timeframe: Participants will be on study average of 4 months.

Outcome measures
Measure	Usual Care n=13 Participants Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.	ABPM Guided n=8 Participants Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan. Amlodipine: Amlodipine 5 mg or 10 mg Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg Losartan: Losartan 50 mg or 100 mg
24 Hour Blood Pressure Average at the End of 4 Month Participation.	134 mm Hg Standard Deviation 11	132 mm Hg Standard Deviation 10

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Usual Care n=14 participants at risk Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.	ABPM Guided n=14 participants at risk Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan. Amlodipine: Amlodipine 5 mg or 10 mg Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg Losartan: Losartan 50 mg or 100 mg
Metabolism and nutrition disorders electrolyte	7.1% 1/14 • Number of events 1	7.1% 1/14 • Number of events 1

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