Trial Outcomes & Findings for A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension (NCT NCT01658657)

NCT ID: NCT01658657

Last Updated: 2015-08-27

Results Overview

At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (\<140mmHG systolic and \<90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2015-08-27

Participant Flow

Participant milestones

Measure	PRA-guided Therapy Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline. Hydrochlorothiazide Lisinopril Amlodipine metoprolol	Fixed-dose Combination Treatment-guided Therapy Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level. Amlodipine metoprolol lisinopril/hydrochlorothiazide
Overall Study STARTED	7	10
Overall Study COMPLETED	4	7
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Plasma Renin Activity Guided vs Generic Combination Therapy for Hypertension

Baseline characteristics by cohort

Measure	PRA-guided Therapy n=7 Participants Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline. Hydrochlorothiazide Lisinopril Amlodipine metoprolol	Fixed-dose Combination Treatment-guided Therapy n=10 Participants Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level. Amlodipine metoprolol lisinopril/hydrochlorothiazide	Total n=17 Participants Total of all reporting groups
Age, Continuous	47.6 years n=93 Participants	46.7 years n=4 Participants	47 years n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	5 Participants n=4 Participants	7 Participants n=27 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	5 Participants n=4 Participants	10 Participants n=27 Participants
Region of Enrollment United States	7 participants n=93 Participants	10 participants n=4 Participants	17 participants n=27 Participants

PRIMARY outcome

Timeframe: 4 months

Population: 6 participants withdrawn before study completion

At each study visit (approximately every 30 days), participants' BP will be checked. If BP is controlled (<140mmHG systolic and <90mmHG diastolic), then current medication will continue. If BP is uncontrolled, medication will be revised every 30 days (up to 120) until BP control is achieved.

Outcome measures

Measure	PRA-guided Therapy n=4 Participants Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline. Hydrochlorothiazide Lisinopril Amlodipine metoprolol	Fixed-dose Combination Treatment-guided Therapy n=7 Participants Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level. Amlodipine metoprolol lisinopril/hydrochlorothiazide
Blood Pressure Control, as Defined as Office BP Measurement of <140 mmHg Systolic and <90 mmHg Diastolic	3 participants	1 participants

Adverse Events

PRA-guided Therapy

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Fixed-dose Combination Treatment-guided Therapy

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	PRA-guided Therapy n=7 participants at risk Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline. Hydrochlorothiazide Lisinopril Amlodipine metoprolol	Fixed-dose Combination Treatment-guided Therapy n=10 participants at risk Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level. Amlodipine metoprolol lisinopril/hydrochlorothiazide
Blood and lymphatic system disorders Electrolyte disturbance	28.6% 2/7 • Number of events 2	20.0% 2/10 • Number of events 2
General disorders Lightheadedness	14.3% 1/7 • Number of events 1	20.0% 2/10 • Number of events 2

Additional Information

Anthony Viera

UNC Chapel Hil

Phone: 919-966-0758

Email: viera@med.unc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place