Improving Cardiovascular Health in Patients With Chronic Obstructive Pulmonary Disease

NCT03819517 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: HM20014536
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (3)

• Change in Sirt1 concentrations

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

  Baseline to 12 weeks

• 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

• 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 Outcomes (2)

• Change in Nitric Oxide metabolism

  Baseline to 12 weeks

• Change in Inflammatory activation

  Baseline to 12 weeks

Study Arms (2)

Resveratrol

ACTIVE COMPARATOR

500 mg of time released micronized trans-Resveratrol

Drug: Resveratrol

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Resveratrol DRUG

Over the counter supplementation

Resveratrol

Placebo OTHER

Empty white colored soft vegetarian capsule

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Paula Rodriguez Miguelez, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: January 28, 2019
• Study Start: July 1, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2023
• Last Updated: April 29, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)