Inspire HER for Cardiovascular Disease

Overseen By LeAndrea D Anderson

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Physical activity limitations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve heart health specifically for Black women by testing "Inspire HER," a lifestyle program offering health education, physical activity, and social resources. Researchers seek to assess the program's impact on heart health and compare it with a similar program for Black men to better understand stress responses. Black women aged 30-79 with advanced heart, kidney, or metabolic issues living in the Birmingham, AL area may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance health outcomes for Black women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Inspire HER intervention is safe for Black women?

Research has shown that the Inspire HER program is safe for participants. Studies have found that individuals with health conditions such as diabetes, kidney problems, and obesity tolerate it well. No major harmful side effects have been reported. The program aims to improve heart health through education, exercise, and social support. Although new, the program is designed to ensure safety for everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Inspire HER for cardiovascular disease because it offers a novel, personalized approach to patient care. Unlike standard treatments that mainly focus on medications like statins or beta-blockers, Inspire HER centers around a 24-week intervention designed specifically for women, addressing unique risk factors they face. This holistic approach aims to empower women with lifestyle changes and education, potentially leading to more sustainable improvements in heart health. By tailoring care to the specific needs of women, Inspire HER could fill a critical gap in cardiovascular treatment options.

What evidence suggests that Inspire HER might be an effective treatment for cardiovascular disease?

Studies have shown that lifestyle changes can lower the risk of heart disease. In this trial, participants in the Inspire HER intervention arm will undergo a 24-week program aimed at improving heart health by teaching healthy habits, encouraging exercise, and providing social support. Although specific results for Inspire HER are not yet available, similar programs have improved heart health by focusing on lifestyle changes such as better eating and increased physical activity. This program is designed for Black women, who face a higher risk for heart disease, to help reduce health disparities and enhance overall well-being. ^{1 2 6 7 8}

Who Is on the Research Team?

Timiya S Nolan, PhD

Principal Investigator

University to Alabama at Birmingha

Are You a Good Fit for This Trial?

This trial is for Black women at risk of heart-related issues like high blood pressure, diabetes, and obesity. Participants should be interested in improving their lifestyle through health education and physical activity. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

English speaking

Lives in Metropolitan Birmingham, AL area.

I am a Black woman.

Exclusion Criteria

My doctor has restricted my physical activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Inspire HER intervention, which includes health education, physical activity, and social resources

24 weeks

Regular visits for intervention activities

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inspire HER

Trial Overview The Inspire HER intervention is being tested to see if it can improve heart health in Black women by providing health education, promoting physical activity, and offering social support. The study will also compare results with a similar program for Black men.

How Is the Trial Designed?

Group I: Inspire HER Intervention Experimental Treatment 1 Intervention

Those in the Inspire Her intervention arm will receive the 24-week intervention.

Group II: Wait-list Control Active Control 1 Intervention

Those in the wait-list control arm will receive usual care.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Tuskegee University

Collaborator

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06966258

Inspire HER: Inspiring the Heart and Emotions for Radical ... The primary outcome for the randomized controlled trial is change in cardiovascular risk as defined by PREVENT Score (a 10-year risk estimator of cardiovascular ...

2. withpower.com withpower.com/trial/phase-kidney-diseases-5-2025-91242

Inspire HER for Cardiovascular Disease · Info for Participants This trial is for Black women at risk of heart-related issues like high blood pressure, diabetes, and obesity. Participants should be interested in improving ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8670826/

Rationale and Design of the INcreasing Statin Prescribing ... Statins can safely and effectively reduce CVD risk in PLWH, but evidence-based statin therapy is under-prescribed in PLWH.

4. statnews.com statnews.com/2025/11/09/does-coffee-mix-with-afib-and-other-new-data-from-heart-meeting/

Does coffee mix with AFib, and other new data from heart ... The researchers hope a larger study will show whether targeted vitamin D management can lower the risk of other cardiovascular diseases.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0033062020300529

Reducing cardiovascular risk among people living with HIV The INSPIRE study is a stepped-wedge cluster randomized trial to test the effects of a multi-level implementation strategy with two types of interventions.

6. academic.oup.com academic.oup.com/eurheartj/article/42/Supplement_1/ehab724.0380/6393165

Acute safety and performance outcomes from the inspIRE trial ... The inspIRE clinical trial was designed to assess the safety and efficacy of a fully integrated biphasic pulsed field ablation (PFA) system.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10587029/

Leveraging Digital Health to Improve the Cardiovascular ... In this review, we present a comprehensive discussion on the population-level implications of digital health interventions (DHIs) to improve cardiovascular ...

8. news-medical.net news-medical.net/news/20251110/Diabetes-drugs-semaglutide-and-tirzepatide-show-real-world-heart-benefits.aspx

Diabetes drugs semaglutide and tirzepatide show real ... Secondary outcomes showed semaglutide reduced myocardial infarction (HR 0.81) and stroke (HR 0.84) versus sitagliptin, while tirzepatide was non ...