Healthy Heart Program for High Blood Pressure and High Cholesterol

Overseen By Laurie Norton, MA, MBE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Must be taking: Statins

Must not be taking: PCSK9 inhibitors

Disqualifiers: Pregnancy, Breastfeeding, Metastatic cancer, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

1980 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing a program to improve blood pressure and cholesterol levels over six months. Participants will join a group that uses a blood pressure monitor and follows a program designed to promote heart health. The trial is open to Penn Medicine patients in West/Southwest Philadelphia and Lancaster who have high blood pressure and high cholesterol and are not currently on certain cholesterol-lowering medications. The study aims to find better ways to manage these conditions through lifestyle changes. As an unphased trial, it offers participants the opportunity to contribute to innovative heart health strategies and potentially improve their own health through lifestyle changes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it seems to focus on patients not using certain cholesterol medications like PCSK9 inhibitors or high-intensity statins. It's best to discuss your specific medications with the trial team.

What prior data suggests that the Penn Med Healthy Heart Program is safe?

Research has shown that the Penn Med Healthy Heart Program helps people manage high blood pressure and cholesterol through personalized plans. The program emphasizes lifestyle changes and correct medication use. While specific safety data from the program's trials is unavailable, it focuses on behavior change rather than introducing a new drug or device. This typically results in a lower risk of side effects compared to treatments involving medication or surgery. The program aims to improve health by lowering blood pressure and cholesterol, both crucial for heart health. For any concerns, consulting a doctor is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Penn Med Healthy Heart Program is unique because it integrates technology with health education to tackle high blood pressure and high cholesterol. Unlike traditional treatments that might focus solely on medication like statins or ACE inhibitors, this program uses a blood pressure monitor and guides participants through four modules designed to promote healthier lifestyle choices. Researchers are excited about this approach because it empowers individuals to manage their own health actively, potentially offering a sustainable way to improve heart health beyond just medication. By combining tech-driven monitoring with educational support, this program aims to address the root causes of these conditions more comprehensively.

What evidence suggests that the Penn Med Healthy Heart Program is effective for improving blood pressure and cholesterol?

Research has shown that the Penn Med Healthy Heart Program, which participants in this trial may receive, can lower blood pressure and bad cholesterol. Studies found that people who completed the six-month program achieved better results than those who received usual care. The program helps participants create a personalized plan for medication and lifestyle changes. These improvements suggest the program might effectively manage high blood pressure and cholesterol. ^{1 2 3 4 5}

Who Is on the Research Team?

Kevin Volpp, MD PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for Penn Medicine patients in West/Southwest Philadelphia and Lancaster with high blood pressure or cholesterol. Eligible participants may have heart disease, a risk score of ≥10%, diabetes, an A1c level ≥6.5, or LDL levels ≥190 within the past five years. They must not be on certain cholesterol medications and have had high systolic blood pressure readings recently.

Inclusion Criteria

Last 2 Blood Pressure readings with Systolic Blood Pressure >=140 from any outpatient encounter in the last 12 months

On the Penn Medicine Primary Care Service Line registry

I have heart disease, diabetes, high cholesterol, or am at high risk for heart disease.

Exclusion Criteria

Documented statin allergy/ or intolerance in the EMR

Pregnancy

I need a translator to communicate in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Penn Medicine Healthy Heart program, which includes receiving a blood pressure monitor and completing 4 HDPP modules over 6 months

6 months

Follow-up

Participants are monitored for changes in blood pressure and cholesterol levels after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Penn Med Healthy Heart Program

Trial Overview The trial tests the Penn Med Healthy Heart Program aimed at changing patient behavior to improve blood pressure and cholesterol over six months using EPIC tools for patient identification and the Way to Health platform for program enrollment.

How Is the Trial Designed?

Group I: Penn Med Healthy Heart Program Experimental Treatment 1 Intervention

The Intervention group will receive the blood pressure monitor and move through the 4 HDPP modules of the intervention.

Group II: Usual Care Active Control 1 Intervention

This group will not receive the intervention and will continue with usual care.

Penn Med Healthy Heart Program is already approved in United States for the following indications:

Approved in United States as Penn Medicine Healthy Heart for:

• Cardiovascular disease risk reduction
• Hypertension management
• Cholesterol management

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

In the Chicago Coronary Prevention Evaluation Program, a nonpharmacologic regimen led to significant long-term reductions in blood pressure, with hypertensive men experiencing an average drop of about 10/13 mm Hg.

The study found a strong correlation between weight loss and blood pressure reduction, suggesting that improved eating and exercise habits can effectively manage mild hypertension and prevent high blood pressure in at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention and control of hypertension by nutritional-hygienic means. Long-term experience of the Chicago Coronary Prevention Evaluation Program. Stamler, J., Farinaro, E., Mojonnier, LM., et al.[2016]

The National High Blood Pressure Education Program (NHBPEP) has significantly increased public awareness, treatment, and control of hypertension, leading to a remarkable decline in heart disease and stroke mortality rates by 70% and 80%, respectively, over four decades.

This decline in mortality rates is observed across different demographics, including both sexes and racial groups, particularly benefiting those in the southeastern U.S., despite rising obesity and diabetes rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The treatment of hypertension: a remarkable success story. Moser, M., Roccella, EJ.[2023]

The Minnesota Heart Health Program is a comprehensive ten-year initiative aimed at preventing coronary heart disease through community-wide efforts, including systematic hypertension screening and educational programs.

By implementing multiple strategies across different sites and conducting annual surveys, the program aims to gather evidence on the effectiveness of these prevention methods in reducing heart disease risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention and treatment of hypertension at the population level: the Minnesota Heart Health Program]. Murray, D., Luepker, R., Grimm, R., et al.[2017]

A community intervention targeting hypertension in predominantly racial/ethnic minority neighborhoods led to significant blood pressure improvements, especially in individuals with severely elevated blood pressure (≥160/100 mmHg), who saw a reduction from 165.4/98.3 mmHg to 150.4/90.8 mmHg.

After 3 months, 55.2% of participants with severely elevated blood pressure achieved controlled levels, demonstrating the effectiveness of education and empowerment strategies in managing hypertension in high-risk communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations. Prendergast, HM., Escobar-Schulz, S., Del Rios, M., et al.[2022]

The Hypertension Disease Management Program (HDMP) significantly reduced systolic and diastolic blood pressure in participants, with systolic pressure decreasing from 137.5 mm Hg to 131.2 mm Hg and diastolic pressure from 86.0 mm Hg to 83.8 mm Hg, indicating its efficacy in managing hypertension.

Participants in the HDMP showed improved health behaviors, such as better dietary choices and regular blood pressure monitoring, but there was no significant change in medical service usage or costs compared to the control group, suggesting that while HDMP enhances lifestyle, its impact on healthcare utilization remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the hypertension disease management program in Korea. Kim, Y., Lee, K., Shin, E., et al.[2019]

The HEROIC study involved 226 physicians and assessed the impact of an educational program on blood pressure control in nearly 2500 hypertensive patients, resulting in a small but significant reduction of -1.1 mm Hg in systolic blood pressure after one year.

While there was a slight increase in the proportion of patients reaching their blood pressure targets (from 13.6% to 15.6%), the overall improvement was not enough to prevent the risk of developing heart failure, indicating that more intensive interventions are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Interventional Program to Improve Blood Pressure Control in Hypertensive Patients at High Risk for Developing Heart Failure: HEROIC study. De Rivas, B., Barrios, V., Redón, J., et al.[2021]

The Healthy Heart community-based cardiac rehabilitation program was well-received by participants, who reported increased confidence and responsibility in managing their health after completing the 8-week program.

Despite the program's success in improving participants' health objectively, many struggled to maintain motivation and self-management strategies after it ended, highlighting the need for ongoing support in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feeling supported and abandoned: mixed messages from attendance at a rural community cardiac rehabilitation program in Australia. Fletcher, SM., Burley, MB., Thomas, KE., et al.[2015]

The Healthy Heart Africa program significantly improved healthcare providers' knowledge about hypertension risk factors and management methods over a 12-month period in Kenya, enhancing their ability to provide care.

Facilities involved in the program showed increased hypertension screening practices and better access to medications, although the overall increase in diagnosed patients seeking treatment was not statistically significant compared to control facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Heart Africa-Kenya: A 12-Month Prospective Evaluation of Program Impact on Health Care Providers' Knowledge and Treatment of Hypertension. Ogola, EN., Okello, FO., Herr, JL., et al.[2020]

The Healthy Heart Community Prevention Project (HHCPP) effectively uses community venues like barbershops and beauty salons for blood pressure screenings, targeting African American populations in New Orleans who face higher cardiovascular risks.

The program includes educational initiatives for health professionals and community engagement through church sermons and sports events, demonstrating a comprehensive approach to reducing cardiovascular disease in low socioeconomic status groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from the Healthy Heart Community Prevention Project in reaching the African American population. Ferdinand, KC.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39341482/

Design and rationale of penn medicine healthy heart, a ... Primary hypothesis: Penn Medicine Healthy Heart will significantly improve systolic blood pressure and LDL-C compared to usual care over the 6 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S000287032400262X

Design and rationale of penn medicine healthy heart, a ... Penn Medicine Healthy Heart will significantly improve systolic blood pressure and LDL-C compared to usual care over the 6 months of this intervention.

3. med.upenn.edu med.upenn.edu/healthyheart/

Welcome to Penn Medicine Healthy Heart Based on your numbers, we will help you create and stick to a plan for blood pressure and cholesterol medicine and lifestyle changes that are right for you.

4. pennmedicine.org pennmedicine.org/news/a-personal-companion-to-heart-health-starting-with-your-thumbs

Penn Healthy Heart: a personal companion to heart health Better clinical outcomes are lower blood pressures and lower cholesterol for patients who have finished the six-month program.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06062394/penn-medicine-healthy-heart

Penn Medicine Healthy Heart | Clinical Research Trial Listing The clinical trial will assess Penn Medicine Healthy Heart and will be powered to detect differences in improving blood pressure and cholesterol ...