Skip to main content
OpenTrials
Completed

NCT Number: NCT03819517

Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%
  • Matched healthy volunteers without COPD.

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

Treatment and study plan

Resveratrol

Drug

Over the counter supplementation

Placebo

Other

Empty white colored soft vegetarian capsule

Primary outcomes

  1. Change in Sirt1 concentrations

    Time frame: Baseline to 12 weeks

    Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jan 28, 2019
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.