Diastolic Dysfunction Clinical Trial
— CardiacAgingOfficial title:
Prevention of Age-associated Cardiac and Vascular Dysfunction Through Nrf2 Signaling Using the Nutritional Supplement Sulforaphane
Our local IRB approved clinical studies seeking proof of principle for the hypothesis that SFN can be safely administered to humans at doses sufficient to protect age-associated cardiac dysfunctions. Beneficial effects of SFN-therapy will be assessed by Pre- and post-intervention echocardiography, and exercise endurance at 0 and 24 weeks. Peripheral blood cells from treated and control subjects will be compared for mitochondrial respiratory function, oxidative damage, pro-inflammatory cytokines, and expression of antioxidant & anti-electrophile genes.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | July 30, 2026 |
Est. primary completion date | August 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age > 60 years - Diagnosis of HFpEF (HF symptoms with a normal EF (>/=50 %) - Ability to walk more than 500 feet (by self-report) - Willing to avoid taking all over the counter antioxidant phytochemical supplements (vegetable or fruit-containing supplement pills) during the study Exclusion Criteria: - Inability to provide informed consent - Diagnosis of active cancer - Inability to read and understand the SF-36 in English - Participants using over the counter antioxidant supplements - Participants with pulmonary or other issues which restrict walking capacity - On oxygen therapy |
Country | Name | City | State |
---|---|---|---|
United States | Texas Tech University Health Sciences Center (TTUHSC) | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | DNA damage, CBC, Oxidative stress | Measured in Peripheral Blood cells | 0 week | |
Other | DNA damage, CBC, Oxidative stress | Measured in Peripheral Blood cells | 24 weeks | |
Primary | cardiac function | LV ejection fraction at baseline and 24 weeks
Left ventricular global longitudinal strain at baseline and 24 weeks Left ventricular diastolic function at baseline and 24 weeks |
0 week | |
Primary | cardiac function | LV ejection fraction at baseline and 24 weeks
Left ventricular global longitudinal strain at baseline and 24 weeks Left ventricular diastolic function at baseline and 24 weeks |
24 week | |
Primary | Functional Capacity | Exercise capacity in METS at baseline and 24 weeks | 0 week | |
Primary | Functional Capacity | Exercise capacity in METS at baseline and 24 weeks | 24 week | |
Secondary | Muscle Function | Muscle function will be determined by established strength and endurance tests | 0 week | |
Secondary | Muscle Function | Muscle function will be determined by established strength and endurance tests | 24 week | |
Secondary | Hand grip test | Determined using a Jamar hand dynamometer | 0 week | |
Secondary | Hand grip test | Determined using a Jamar hand dynamometer | 24 week |
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