Trial Outcomes & Findings for The Effect of Renin Inhibition on Nerve Function in Diabetes (NCT NCT00935064)

NCT ID: NCT00935064

Last Updated: 2016-08-09

Results Overview

Systolic blood pressure at baseline and follow-up

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: baseline and 6 weeks
• Results posted on: 2016-08-09

Participant Flow

Participant milestones

Measure	Aliskiren 300 mg, once daily, for 6 weeks	Placebo Once daily, for 6 weeks
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Renin Inhibition on Nerve Function in Diabetes

Baseline characteristics by cohort

Measure	Aliskiren n=30 Participants 300 mg, once daily, for 6 weeks	Placebo n=30 Participants Once daily, for 6 weeks	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	49 years STANDARD_DEVIATION 12 • n=5 Participants	53 years STANDARD_DEVIATION 12 • n=7 Participants	51 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	11 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 weeks

Systolic blood pressure at baseline and follow-up

Outcome measures

Measure	Aliskiren n=30 Participants 300 mg, once daily, for 6 weeks	Placebo n=30 Participants Once daily, for 6 weeks
Systolic Blood Pressure Before and After Treatment Baseline	121.0 mm Hg Standard Deviation 11.3	124.1 mm Hg Standard Deviation 13.8
Systolic Blood Pressure Before and After Treatment Follow-up	112.1 mm Hg Standard Deviation 12.1	121.5 mm Hg Standard Deviation 15.2

PRIMARY outcome

Timeframe: baseline and 6 weeks

Diastolic blood pressure at baseline and follow-up.

Outcome measures

Measure	Aliskiren n=30 Participants 300 mg, once daily, for 6 weeks	Placebo n=30 Participants Once daily, for 6 weeks
Diastolic Blood Pressure Before and After Treatment Baseline	66.1 mm Hg Standard Deviation 7.0	68.2 mm Hg Standard Deviation 8.3
Diastolic Blood Pressure Before and After Treatment Follow-up	61.5 mm Hg Standard Deviation 6.5	66.7 mm Hg Standard Deviation 9.3

PRIMARY outcome

Timeframe: baseline and 6 weeks

Serum renin level at baseline and follow-up

Outcome measures

Measure	Aliskiren n=30 Participants 300 mg, once daily, for 6 weeks	Placebo n=30 Participants Once daily, for 6 weeks
Serum Renin Level Before and After Treatment Baseline	2.4 ug/l/h Standard Deviation 3.8	3.1 ug/l/h Standard Deviation 6.0
Serum Renin Level Before and After Treatment Follow-up	0.5 ug/l/h Standard Deviation 0.4	2.6 ug/l/h Standard Deviation 4.2

PRIMARY outcome

Timeframe: baseline and 6 weeks

Mean circular resultant at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles. With regard to the MCR, the length of the vector mean is proportional to the degree of HRV. Weinberg and Pfeifer first introduced the assessment of HRV via determination of the MCR in a paper in Biometrics 1984:40:855-861. Low HRV is considered to be less favorable.

Outcome measures

Measure	Aliskiren n=30 Participants 300 mg, once daily, for 6 weeks	Placebo n=30 Participants Once daily, for 6 weeks
Mean Circular Resultant Before and After Treatment Baseline	41.8 MCR is unitless Standard Deviation 19.7	38.2 MCR is unitless Standard Deviation 23.6
Mean Circular Resultant Before and After Treatment Follow-up	50.8 MCR is unitless Standard Deviation 26.1	37.5 MCR is unitless Standard Deviation 24.1

PRIMARY outcome

Timeframe: baseline and 6 weeks

Expiration/inspiration ratio at baseline and follow-up. There are several different assessment modalities used for the determination of cardiovascular autonomic function (i.e. HRV). One widely used clinical method for assessing HRV is RR-variation during deep breathing. RR-variation is a measure of the change in heart rate resulting from the variation in intrathoracic pressure due to respiration. It is predominantly a function of parasympathetic activity. In this study, RR-variation during deep breathing, performed for 6 min, was measured by vector analysis [i.e. mean circular resultant (MCR)] and by the expiration/inspiration (E/I) ratio of the first six breath cycles.

Outcome measures

Measure	Aliskiren n=30 Participants 300 mg, once daily, for 6 weeks	Placebo n=30 Participants Once daily, for 6 weeks
Expiration/Inspiration Ratio Before and After Treatment Follow-up	1.28 Ratio Standard Deviation 0.15	1.20 Ratio Standard Deviation 0.14
Expiration/Inspiration Ratio Before and After Treatment Baseline	1.22 Ratio Standard Deviation 0.12	1.21 Ratio Standard Deviation 0.14

Adverse Events

Aliskiren

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Aliskiren n=30 participants at risk 300 mg, once daily, for 6 weeks	Placebo n=30 participants at risk Once daily, for 6 weeks
Metabolism and nutrition disorders Hyperkalemia	3.3% 1/30 • Number of events 1	10.0% 3/30 • Number of events 3

Additional Information

Dr. Raelene E. Maser

University of Delaware/Christiana Care Health System

Phone: 302-831-8400

Email: rmaser@udel.edu

Results disclosure agreements

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