Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819517
• Other study ID #: HM20014536
• Status: Completed
• Phase: Early Phase 1
• Start date: July 1, 2019
• Est. completion date: August 30, 2023

Study information

• Verified date: September 2023
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Resveratrol
Over the counter supplementation

Other:
• Placebo
Empty white colored soft vegetarian capsule

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sirt1 concentrations	Circulating concentrations of Sirt1 before and 12 weeks after both resveratrol and placebo	Baseline to 12 weeks
Primary	Change in vascular health	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.	Baseline to 12 weeks
Primary	Change in Systemic Inflammation	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.	Baseline to 12 weeks
Secondary	Change in Nitric Oxide metabolism	Nitric oxide metabolism will be evaluated through Nitric oxide synthase expression using western blot analysis	Baseline to 12 weeks
Secondary	Change in Inflammatory activation	The inflammatory cascade of the nuclear factor kappa B will be evaluated through assessment of p65 and p50 expression using western blot analysis	Baseline to 12 weeks