Clinical trial NCT03819517: Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease
Official title: Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease: a Mechanistic Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sirt1 concentrations
timeFrame: Baseline to 12 weeks
measure: Change in vascular health
timeFrame: Baseline to 12 weeks
measure: Change in Systemic Inflammation
timeFrame: Baseline to 12 weeks
Secondary outcomes:
measure: Change in Nitric Oxide metabolism
timeFrame: Baseline to 12 weeks
measure: Change in Inflammatory activation
timeFrame: Baseline to 12 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Paula Rodriguez Miguelez, PhD
role: PRINCIPAL_INVESTIGATOR
References: