Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01349114
• Collaborator: Novartis (Industry)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The study will evaluate the effects of the direct renin inhibitor, aliskiren, on flow-mediated dilation of the brachial artery and on central aortic pressure in diabetic patients with pre-hypertension or Stage 1 hypertension.

Condition or Disease	Intervention/Treatment	Phase
Diabetes; Pre-hypertension; Hypertension	Drug: aliskiren 300 mg once daily; Drug: Placebo/sugar pill	Phase 4

Detailed Description

Patients are double-blind placebo-controlled randomized to either aliskiren or sugar pill/placebo. Effects on blood parameters and arteries are evaluated in both groups.

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Effect of the Direct Renin Inhibitor Aliskiren on Endothelial Function and Arterial Stiffness in Diabetic Subjects
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: aliskiren 300 mg once daily for 12 weeks aliskiren 300 mg daily	Drug: aliskiren 300 mg once daily; aliskiren 300 mg daily; Other Names: Tekturna
Placebo Comparator: Sugar pill/ placebo Patients were double-blind placebo-controlled randomized to either aliskiren 300 mg once daily or sugar pill/ placebo	Drug: Placebo/sugar pill; Sugar pill/placebo

Outcome Measures

Primary Outcome Measures

1. Change in Flow-mediated Dilation [Baseline to 3 months]

   Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion

Secondary Outcome Measures

1. Mean Central Aortic Pressure at 3 Months [3 months after start of study]

   Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 2 diabetes

• prehypertension or Stage 1 hypertension

Exclusion Criteria:

• Type 1 diabetes

• Stage 2 hypertension

• CKD

• recent MI, revascularization, CVA or TIA

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAB	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

• University of Alabama at Birmingham
• Novartis

Investigators

• Principal Investigator: David A Calhoun, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Calhoun, Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT01349114
• Other Study ID Numbers: F110124007
• First Posted: May 6, 2011
• Last Update Posted: May 11, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by David Calhoun, Professor, University of Alabama at Birmingham: aliskiren; endothelial function; hypertension
• Additional relevant MeSH terms: Hypertension; Prehypertension

Study Results

Participant Flow

Arm/Group Title	Aliskiren	Sugar Pill/Placebo
Arm/Group Description	aliskiren 300 mg daily	Sugar pill/placebo arm
Period Title: Overall Study
STARTED	10	11
COMPLETED	10	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Aliskiren	Placebo	Total
Arm/Group Description	aliskiren 300 mg daily	Sugar pill/placebo	Total of all reporting groups
Overall Participants	10	11	21
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 70%	7 63.6%	14 66.7%
>=65 years	3 30%	4 36.4%	7 33.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.3 (11)	63.4 (8.3)	60.7 (9.8)
Sex: Female, Male (Count of Participants)
Female	6 60%	4 36.4%	10 47.6%
Male	4 40%	7 63.6%	11 52.4%
Region of Enrollment (participants) [Number]
United States	10 100%	11 100%	21 100%

Outcome Measures

1. Primary Outcome

Title	Change in Flow-mediated Dilation
Description	Flow-mediated dilation of the brachial artery assessed by ultrasound to evaluate improvement of arterial functioning by % of dilation after non-invasive occlusion
Time Frame	Baseline to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aliskiren	Placebo
Arm/Group Description	aliskiren 300 mg daily	Sugar pill/ placebo
Measure Participants	10	11
Mean (Standard Deviation) [percentage of flow-mediated dilation]	7.9 (2.5)	4.1 (1.3)

2. Secondary Outcome

Title	Mean Central Aortic Pressure at 3 Months
Description	Baseline to 3 months after Aliskiren/PLC, reported value at 3 months after start of study of central aortic pressure assessed by non-invasive applanation tonometry ( SphygmoCor, Atcor)
Time Frame	3 months after start of study

Outcome Measure Data

Analysis Population Description

Aortic pressure indicates the augmentation pressure (AP) in mmHg derived from the radial artery waveform.

Arm/Group Title	Aliskiren	Placebo
Arm/Group Description	aliskiren 300 mg daily aliskiren: aliskiren 300 mg daily	placebo: placebo
Measure Participants	10	11
aortic systolic blood pressure	113.4 (12.0)	122.3 (9.6)
aortic diastolic blood pressure	78.9 (8.9)	83.3 (9.9)
aortic pressure	7.1 (7.2)	10.3 (5.7)

Adverse Events

Arm/Group Title	Aliskiren		Placebo
Arm/Group Description	aliskiren 300 mg daily		Sugar pill/ placebo
All Cause Mortality
	Aliskiren		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Aliskiren		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Aliskiren		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/11 (0%)

Limitations/Caveats

Early termination leading to smaller number of subjects analyzed then anticipated, no adverse effects within the aliskiren group

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.