Prevention Strategy for Heart Failure in Type 2 Diabetes

(STRONG-DM Trial)

Overseen By VINAYAK SUBRAMANIAN, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: No diabetes patients

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Intensive Prevention Strategy for preventing heart failure in people with type 2 diabetes?

Research from the Steno-2 study shows that an intensified multifactorial intervention, which is similar to an intensive prevention strategy, reduced the risk of heart failure and prolonged life in people with type 2 diabetes over a long-term follow-up. ^{1 2 3 4 5}

Is the Intensive Prevention Strategy for heart failure in type 2 diabetes safe for humans?

The EMPA-REG OUTCOME trial showed that empagliflozin, part of the Intensive Prevention Strategy, reduced the risk of major heart-related events and death in people with type 2 diabetes, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How is the Intensive Prevention Strategy treatment for heart failure in type 2 diabetes different from other treatments?

The Intensive Prevention Strategy is unique because it involves an intensified multifactorial intervention, which means it combines several treatments to address multiple risk factors at once, rather than focusing on just one aspect of the disease. This approach has been shown to reduce the risk of heart failure and improve long-term outcomes in patients with type 2 diabetes, as demonstrated in the Steno-2 study. ^{3 7 9 11 12}

What is the purpose of this trial?

A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.

Eligibility Criteria

This trial is for people with Type 2 Diabetes who are at risk of developing heart failure. Participants should not have a current diagnosis of heart failure but must be considered high-risk based on specific clinical scores and biomarkers.

Inclusion Criteria

Primary Care Provider that sees diabetes patients in clinic

Exclusion Criteria

Provider does not see patients with Diabetes

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Risk Assessment and Intensive Prevention Strategy

Primary care providers receive notifications for patients with high heart failure risk and are provided recommendations for evidence-based therapies.

6 months

Ongoing electronic health record alerts

Follow-up

Participants are monitored for incident heart failure or all-cause death via retrospective chart review.

2 years

Treatment Details

Interventions

• Intensive Prevention Strategy

Trial Overview The study tests whether using a special prevention strategy that includes regular health checks, risk assessments, and treatments can help prevent heart failure in high-risk diabetes patients.

Participant Groups

Group I: Risk Assessment and Intensive Prevention Strategy Experimental Treatment 1 Intervention

Primary care providers (PCP) randomized to the Risk Assessment and Intensive Prevention Strategy Arm will receive notification if any patients with diabetes under their care have high heart failure risk based on clinical or biomarker scores. Providers will receive recommendations, option for e-consultation, and referral to cardiometabolic risk management program.

Group II: Usual Care Active Control 1 Intervention

Primary care providers randomized to the Usual care arm will not receive any notifications about patients with diabetes and their HF risk assessment.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Roche Diagnostics GmbH

Industry Sponsor

Trials

68

Recruited

668,000+

Dr. Thomas Schinecker

Roche Diagnostics GmbH

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Dr. Levi Garraway

Roche Diagnostics GmbH

Chief Medical Officer since 2019

MD from Harvard Medical School

Findings from Research

Patients with heart failure (HF) and type 2 diabetes (T2DM) have a significantly shorter median survival time of 3.5 years compared to 4.6 years for those without T2DM, indicating that T2DM severely impacts long-term prognosis in HF patients.

Ischaemic heart disease is a major predictor of mortality in HF patients, particularly in those with T2DM, yet there is a notable underutilization of diagnostic and therapeutic options like coronary angiography and revascularization in this group, suggesting a need for improved treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the prognosis in patients with diabetes and heart failure a matter of unsatisfactory management? An observational study from the Swedish Heart Failure Registry. Johansson, I., Edner, M., Dahlström, U., et al.[2015]

People with type 2 diabetes and heart failure face worse health outcomes, including higher rates of hospitalization and mortality, highlighting the need for effective prevention strategies.

Understanding the underlying causes of heart failure in type 2 diabetes can help identify risk factors and lead to early interventions, with evidence from clinical trials supporting both lifestyle and medication-based approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting and preventing heart failure in type 2 diabetes. Pandey, A., Khan, MS., Patel, KV., et al.[2023]

A 7.8-year intensified multifactorial intervention in individuals with type 2 diabetes significantly reduced the risk of hospitalization for heart failure by 70% over a total follow-up of 21.2 years, highlighting its efficacy in managing this serious complication.

The study involved 160 participants and showed that only 10 patients in the intensive therapy group were hospitalized for heart failure compared to 24 in the conventional therapy group, indicating a strong protective effect of the intensified treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced risk of heart failure with intensified multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: 21 years of follow-up in the randomised Steno-2 study. Oellgaard, J., Gæde, P., Rossing, P., et al.[2018]

In a study of 14,723 individuals with Type 2 diabetes and heart failure, it was found that these patients were older, predominantly female, and had a longer duration of diabetes compared to those without heart failure.

Despite having heart failure, patients showed improved metabolic control, indicated by lower HbA1c levels, likely due to more intensive treatment regimens involving insulin and medications for hypertension and cholesterol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure among people with Type 2 diabetes mellitus: real-world data of 289 954 people from a diabetes database. Stoyanova, D., Stratmann, B., Schwandt, A., et al.[2022]

Heart failure is significantly more common in patients with diabetes, and those with both conditions have a worse prognosis compared to those without diabetes, highlighting the need for targeted treatment strategies.

The sodium glucose cotransporter 2 inhibitor empagliflozin has been shown to effectively reduce hospitalizations for heart failure in patients with type 2 diabetes and high cardiovascular risk, indicating its potential as a therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Mellitus and Heart Failure. Lehrke, M., Marx, N.[2017]

In a study of 8,063 patients with type 2 diabetes, those who started insulin therapy had a significantly higher risk of developing congestive heart failure (CHF), with incidence rates increasing by 2.33 times compared to sulphonylureas and 2.66 times compared to metformin.

Conversely, regimens that included metformin were associated with the lowest incidence rates of CHF, suggesting that metformin may provide protective benefits against heart disease compared to other diabetes medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The incidence of congestive heart failure associated with antidiabetic therapies. Nichols, GA., Koro, CE., Gullion, CM., et al.[2007]

Thiazolidinediones, a class of antidiabetic medications, should be avoided in patients with type 2 diabetes and established heart failure due to their association with an increased risk of heart failure events.

While other glucose-lowering treatments can be used in diabetic patients with heart failure, careful precautions are necessary, highlighting the need for more specific clinical trials to better understand the safety and efficacy of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should antidiabetic treatment of type 2 diabetes in patients with heart failure differ from that in patients without? Gitt, AK., Halle, M., Hanefeld, M., et al.[2017]

In a study of 6,022 hospitalized patients with heart failure and reduced ejection fraction (HFrEF), those with diabetes faced significantly higher risks of serious complications, including intubation (2.69 times more likely), cardiogenic shock (2.01 times), and acute kidney injury (1.67 times).

Patients with diabetes also had a worse overall prognosis, leading to longer stays in the ICU (1.47 days longer) and in the hospital (2.20 days longer) compared to non-diabetic patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes in Patients With Heart Failure With Reduced Ejection Fraction During Hospitalization: A Retrospective Observational Study. Zhou, Y., Wang, M., Wang, S., et al.[2022]

In patients with type 2 diabetes and ischemic heart disease, changes in NT-proBNP levels are strongly linked to the risk of cardiovascular events, particularly hospitalization for heart failure, highlighting its potential as a prognostic marker.

Monitoring NT-proBNP levels over time can help identify patients at higher risk for heart failure, as persistently high or increasing levels indicate a greater risk, regardless of treatment with the DPP-4 inhibitor alogliptin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serial Measurement of Natriuretic Peptides and Cardiovascular Outcomes in Patients With Type 2 Diabetes in the EXAMINE Trial. Jarolim, P., White, WB., Cannon, CP., et al.[2018]

In a study involving 7,020 patients with type 2 diabetes at high cardiovascular risk, empagliflozin significantly reduced the risk of heart failure hospitalization and cardiovascular death compared to placebo, with a hazard ratio of 0.66, indicating a 34% lower risk.

Empagliflozin also improved other heart failure outcomes and reduced all-cause hospitalization rates, demonstrating consistent benefits across patients with and without baseline heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial. Fitchett, D., Zinman, B., Wanner, C., et al.[2023]

In a study of 153,403 patients with newly diagnosed type 2 diabetes followed for nearly 10 years, the development of heart failure (HF) was found to triple the 5-year risk of death compared to patients without any cardiovascular or renal diagnoses.

Heart failure not only posed the highest risk of mortality but also led to the greatest decrease in lifespan (approximately 11.7 months) within 5 years, surpassing other conditions like ischemic heart disease and stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type 2 Diabetes Mellitus and Impact of Heart Failure on Prognosis Compared to Other Cardiovascular Diseases: A Nationwide Study. Zareini, B., Blanche, P., D'Souza, M., et al.[2021]

In a study of 551 elder asymptomatic patients with Stage A heart failure (SAHF), those with Type 2 diabetes mellitus (T2DM) showed significantly worse subclinical left ventricular function and exercise capacity compared to other SAHF patients, indicating a higher risk for heart failure progression.

Over a median follow-up of 1.6 years, T2DM patients had worse outcomes, with factors like obesity, atrial fibrillation, and impaired exercise capacity being linked to a higher risk of new-onset heart failure and all-cause mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variations in subclinical left ventricular dysfunction, functional capacity, and clinical outcomes in different heart failure aetiologies. Wang, Y., Yang, H., Nolan, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Is the prognosis in patients with diabetes and heart failure a matter of unsatisfactory management? An observational study from the Swedish Heart Failure Registry. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Predicting and preventing heart failure in type 2 diabetes. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Reduced risk of heart failure with intensified multifactorial intervention in individuals with type 2 diabetes and microalbuminuria: 21 years of follow-up in the randomised Steno-2 study. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Heart failure among people with Type 2 diabetes mellitus: real-world data of 289 954 people from a diabetes database. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Diabetes Mellitus and Heart Failure. [2017]

6. England pubmed.ncbi.nlm.nih.gov

The incidence of congestive heart failure associated with antidiabetic therapies. [2007]

7. England pubmed.ncbi.nlm.nih.gov

Should antidiabetic treatment of type 2 diabetes in patients with heart failure differ from that in patients without? [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Diabetes in Patients With Heart Failure With Reduced Ejection Fraction During Hospitalization: A Retrospective Observational Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Serial Measurement of Natriuretic Peptides and Cardiovascular Outcomes in Patients With Type 2 Diabetes in the EXAMINE Trial. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Heart failure outcomes with empagliflozin in patients with type 2 diabetes at high cardiovascular risk: results of the EMPA-REG OUTCOME® trial. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Type 2 Diabetes Mellitus and Impact of Heart Failure on Prognosis Compared to Other Cardiovascular Diseases: A Nationwide Study. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Variations in subclinical left ventricular dysfunction, functional capacity, and clinical outcomes in different heart failure aetiologies. [2022]