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Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT03819517
Recruitment Status : Not yet recruiting
First Posted : January 28, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE December 12, 2018
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date April 16, 2019
Estimated Study Start Date  ICMJE April 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Change in Sirt1 concentrations [ Time Frame: Baseline to 12 weeks ]
    Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo
  • Change in vascular health [ Time Frame: Baseline to 12 weeks ]
    Assessment of vascular health through the evaluation of peripheral vascular using the flow-mediated dilation technique before and 12 weeks after both resveratrol and placebo.
  • Change in Systemic Inflammation [ Time Frame: Baseline to 12 weeks ]
    Systemic inflammation will be evaluated through the assessment of interleukin concentrations using enzyme-linked immunosorbent assay before and 12 weeks after both resveratrol and placebo.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03819517 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • Change in Nitric Oxide metabolism [ Time Frame: Baseline to 12 weeks ]
    Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis
  • Change in Inflammatory activation [ Time Frame: Baseline to 12 weeks ]
    The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease
Official Title  ICMJE Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach
Brief Summary Researchers have found a link between chronic obstructive pulmonary disease (COPD) and heart disease; however, a link is all they have found. Cardiovascular health in COPD is controlled by different mechanisms including vascular health and systemic inflammation. The investigators have collected preliminary data to support that concentrations of Sirtuin 1 (Sirt1), a protein that plays a key role in cardioprotection, may be involved in cardiovascular health in patients with COPD. Resveratrol, an over the counter natural polyphenol found in a variety of food, is a direct activator of Sirt1 and has been used to improve cardiovascular health in different cohorts. The current project is an attempt to expand previous findings and explore the effects of the sub-chronic use of resveratrol in sustaining the improvements in cardiovascular health in COPD.
Detailed Description The present study is designed as a double-blind, randomized, cross-over, placebo-controlled protocol. Patients with COPD will receive either resveratrol (500 mg) or placebo for 12 weeks. A comprehensive evaluation of cardiovascular health will be performed. Results will provide novel insights into the mechanistic role that Sirt1 mediates in COPD related vascular dysfunction and systemic inflammation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Dietary Supplement: Resveratrol
    Over the counter supplementation
  • Other: Placebo
    Empty white colored soft vegetarian capsule
Study Arms  ICMJE
  • Active Comparator: Resveratrol
    500 mg of time released micronized trans-Resveratrol
    Intervention: Dietary Supplement: Resveratrol
  • Placebo Comparator: Placebo
    Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented
    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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with a clinical diagnosis of COPD known for at least one year will be allowed to participate
  • Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages II to IV
  • Breathing test ratio (FEV1/FVC) <0.7
  • Amount of exhaled air (FEV1) <80% predicted after bronchodilator
  • Total Lung Capacity (TLC)>80%.

Exclusion Criteria:

  • FEV1/FVC>0.7
  • Clinical diagnosis of heart disease, hypertension or diabetes
  • Use of vasoactive medications (nitrates, Beta blockers)
  • Uncontrolled high blood pressure
  • Pulmonary hypertension
  • Fluid in the lungs
  • Sleep apnea
  • Thyroid problems
  • Anemia
  • Raynaud's phenomenon
  • Gastrointestinal bleeding
  • History of coagulopathies
  • History of low platelets
  • Gangrene of the digits
  • Phenylketonuria
  • Pregnant or women attempting to become pregnant
  • In lactation
  • Individuals who may not be able to read or understand the resveratrol label
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Paula Rodriguez Miguelez, PhD 804-828-8088 prodriguezmig@vcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03819517
Other Study ID Numbers  ICMJE HM20014536
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paula Rodriguez Miguelez, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date April 2019

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