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Trial record 34 of 534 for:    NITRATE ION

Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease

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ClinicalTrials.gov Identifier: NCT01983826
Recruitment Status : Completed
First Posted : November 14, 2013
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Darren P Casey, University of Iowa

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 14, 2013
Results First Submitted Date  ICMJE October 9, 2018
Results First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • Change in Vasodilator Capacity [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]
    Forearm and calf blood flow will be measured independently by venous occlusion plethysmography using mercury-in-silastic strain gauges. Plethysmographic measurements will be made at rest and following 5 minutes of ischemia (reactive hyperemia) of the distal limb (forearm and calf). Peak blood flow will be determined as the highest flow recorded during the post deflation period. Total blood flow will be measured as the area under the time-curve after resting flow is subtracted. Vascular conductance will be calculated using blood flow/mean arterial pressure (via finger plethysmograph).
  • Change in Arterial Stiffness [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]
    ECG gated arterial waveforms will be obtained via applanation tonometry from the carotid and femoral arteries. The pulse wave velocity (PWV; index of arterial stiffness) will be determined between the carotid and femoral measurement sites (cfPWV). The time (t) between the feet of recorded pressure waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated from the distance (D; meters) between measurement points and the measured time delay (t): PWV = D/Δt (m/s).
  • Change in Functional Capacity - Distance Walked in 6 Minutes [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]
    6-minute walk tests will be performed before and after treatment to assess functional capacity. The main comparisons will be changes distance walked in 6 minutes after 8 weeks of dietary nitrate supplementation.
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2013)
  • Change in Vasodilator Capacity [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]
    Forearm and calf blood flow will be measured independently by venous occlusion plethysmography using mercury-in-silastic strain gauges. Plethysmographic measurements will be made at rest and following 5 minutes of ischemia (reactive hyperemia) of the distal limb (forearm and calf). Peak blood flow will be determined as the highest flow recorded during the post deflation period. Total blood flow will be measured as the area under the time-curve after resting flow is subtracted. Vascular conductance will be calculated using blood flow/mean arterial pressure (via finger plethysmograph).
  • Change in Arterial Stiffness [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]
    ECG gated arterial waveforms will be obtained via applanation tonometry from the carotid and femoral arteries. The pulse wave velocity (PWV; index of arterial stiffness) will be determined between the carotid and femoral measurement sites (cfPWV). The time (t) between the feet of recorded pressure waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated from the distance (D; meters) between measurement points and the measured time delay (t): PWV = D/Δt (m/s).
  • Change in Functional Capacity [ Time Frame: Pre and post 8 weeks of dietary nitrate supplementation ]
    6-minute walk tests will be performed before and after treatment to assess functional capacity. The main comparisons will be changes distance walked in 6 minutes and time to claudication after 8 weeks of dietary nitrate supplementation.
Change History Complete list of historical versions of study NCT01983826 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease
Official Title  ICMJE Dietary Nitrates and Vascular Function in Patients With Peripheral Artery Disease
Brief Summary The overarching question addressed in the current project is: Does dietary nitrate supplementation (8 weeks) improve physiological function in patients with peripheral arterial disease (PAD)? The investigators will specifically address whether dietary nitrate supplementation enhances blood vessel function, blood pressure regulation, and exercise capacity. The proposed project uses an array of clearly defined measurements which will allow investigators to quantify blood vessel function (vasodilator responsiveness and arterial stiffness), blood pressure (variability and responsiveness to stress), and functional capacity before and after 8 weeks of dietary supplementation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Peripheral Artery Disease
Intervention  ICMJE
  • Dietary Supplement: Sodium Nitrate
    Sodium Nitrate (1g/day) for 8 weeks
  • Other: Placebo
    Microcrystalline cellulose (daily) for 8 weeks
Study Arms  ICMJE
  • Experimental: Sodium Nitrate
    Sodium Nitrate (1g/day) for 8 weeks
    Intervention: Dietary Supplement: Sodium Nitrate
  • Placebo Comparator: Placebo capsule
    Microcrystalline cellulose (daily) for 8 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2017)
21
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2013)
30
Actual Study Completion Date  ICMJE June 30, 2016
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented peripheral artery disease
  • Ankle-Brachial Index (ABI) < or = to 0.90

Exclusion Criteria:

  • Non-atherosclerotic vascular disease
  • Critical limb ischemia
  • Active ischemic ulceration
  • Recent (within one year) revascularization
  • Symptomatic coronary artery disease (angina pectoris)
  • Heart failure
  • Resting systolic blood pressure > 180 mmHg or diastolic pressure > 100 mmHg
  • Hypotension (resting systolic BP < 90 mmHg)
  • Smoking or history of smoking within past one year
  • Use of phosphodiesterase V inhibitor drugs
  • Women with history of hormone replacement therapy within the past 6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01983826
Other Study ID Numbers  ICMJE 201307745
13GRNT16490002 ( Other Grant/Funding Number: American Heart Association )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Darren P Casey, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE American Heart Association
Investigators  ICMJE
Principal Investigator: Darren P Casey, Ph.D. University of Iowa
PRS Account University of Iowa
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP