Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

Virginia Commonwealth University (VCU)

Status and phase: Completed; Early Phase 1

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Resveratrol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03819517

HM20014536

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 2 patient groups, including a placebo group

Resveratrol

Active Comparator group

Description:

500 mg of time released micronized trans-Resveratrol

Treatment:

Drug: Resveratrol

Placebo

Placebo Comparator group

Description:

Placebo will be used in the form of an empty white colored soft vegetarian capsule as resveratrol is presented

Treatment:

Other: Placebo