Clinical trial

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

Name
HM20014536
Description
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.
Trial arms
Trial start
2019-07-01
Estimated PCD
2022-08-30
Trial end
2023-08-30
Status
Completed
Phase
Early phase I
Treatment
Resveratrol
Over the counter supplementation
Arms:
Resveratrol
Placebo
Empty white colored soft vegetarian capsule
Arms:
Placebo
Size
26
Primary endpoint
Change in Sirt1 concentrations
Baseline to 12 weeks
Change in vascular health
Baseline to 12 weeks
Change in Systemic Inflammation
Baseline to 12 weeks
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}
Updated at
2024-04-29

1 organization

1 product

1 indication