Cooling Methods for Heart Failure

Overseen By Erin Harper, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Cancer, Diabetes, Lung disease, others

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

Compensation: Varies

Number of Visits: Unknown

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores methods to keep individuals with congestive heart failure cool during heatwaves. Researchers are testing whether wetting the skin or cooling the arms and hands can prevent dangerous body temperature increases and reduce heart stress. Participants will experience simulated heatwave conditions using various cooling methods, including IEEM-Heat. Individuals diagnosed with moderate congestive heart failure and those who are generally healthy without other serious illnesses may qualify for this study.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance comfort and safety during heatwaves.

What prior data suggests that these cooling methods are safe for individuals with heart failure?

Research shows that hot weather can challenge people with heart failure. High temperatures can make the heart work harder and increase the risk of heat-related illnesses like heat exhaustion or heat stroke. The new treatment, IEEM-Heat, uses cooling methods to help manage body temperature and reduce heart stress for people with congestive heart failure.

Previous studies have found that cooling techniques, such as wetting the skin or using cool water on the hands and forearms, can lower body temperature and ease heart strain. These methods are designed to be safe and easy to tolerate.

Although the FDA has not yet approved this specific treatment, the cooling methods it uses have been studied before. They generally show promise in helping people handle heat stress without major side effects. Participants in past research did not report serious side effects, suggesting these cooling techniques might be safe to use.

For those considering joining this clinical trial, these methods could offer a safe way to manage high heat and reduce heart strain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cooling Methods for Heart Failure trial because it explores the potential of using thermal regulation, a novel approach for managing heart failure. Unlike standard treatments that focus on medications like ACE inhibitors, beta-blockers, or diuretics to manage symptoms and improve heart function, this trial investigates whether cooling the body can directly affect heart performance and reduce stress on the heart. This method could offer a unique, non-pharmacological option for patients, potentially minimizing side effects associated with drug therapies. Researchers hope to uncover new insights into how temperature control can aid in heart failure management, potentially opening doors to innovative treatment strategies.

What evidence suggests that these cooling methods are effective for heart failure?

Research has shown that cooling methods might help people with congestive heart failure (CHF) handle heat better. This trial will compare participants with CHF to individuals without CHF to evaluate the effectiveness of these methods. Studies have found that keeping the skin wet can lower body temperature, potentially reducing stress on the heart in hot weather. Early results suggest that cooling the hands and forearms in cool water can also help manage body temperature and ease heart strain. Researchers are studying this method as a way to assist those with CHF during heat waves, possibly improving heart function and reducing heart strain. Although direct data on this specific method remains limited, the cooling techniques are based on well-established principles of managing heat and heart health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with congestive heart failure who will be exposed to simulated heat wave conditions. The study aims to include both those affected by heart failure and healthy controls to compare responses.

Inclusion Criteria

I am over 35 and have heart failure classified as NYHA class II or III.

I am over 35, healthy, with no major medical issues and a normal heart test.

Exclusion Criteria

Participants with CHF who do not have confirmed diagnosis of NYHA class II or III heart failure will be excluded from the clinical group. Potential participants with cancer, diabetes, neurological disease, lung disease, and/or uncontrolled hypertension will be excluded. Potential participants with a left bundle branch block on ECG will be excluded, as well as those with an ejection fraction >40%. Patients on anticoagulant therapy will also be excluded. Participants with a body mass index ≥ 35 kg/m2 will be excluded. Current smokers, as well as individuals who regularly smoked within the past 12 months, will be excluded. Further exclusions will include severe valvular or congenital heart disease, acute myocarditis, NYHA Class IV heart failure, and/or manifest/provocable ischemic heart disease.

I am healthy but cannot join if I have serious health issues, am a current or recent smoker, or have a BMI ≥ 35.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulated Heat Wave Exposure

Participants are exposed to simulated heat wave conditions with different cooling modalities: control, skin wetting, and cool water limb immersion in a randomized crossover fashion.

Approximately 180 minutes per exposure

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after each simulated heat wave exposure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IEEM-Heat

Trial Overview The study tests if increasing skin wetness or cooling the hands and forearms can reduce body temperature and cardiac stress during heat waves in heart failure patients. Participants undergo control, skin-wetting, and limb-cooling trials randomly.

How Is the Trial Designed?

Group I: Individuals without Congestive Heart Failure (Control) Active Control 3 Interventions

Group II: Individuals with Congestive Heart Failure (CHF) Active Control 3 Interventions

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9167063/

Electronic Health Records and Heart Failure - PMC Effectiveness of Evidence-Based Congestive Heart Failure(CHF) CPOE Order Sets Measured by Health Outcomes. AMIA Annu Symp Proc. 2014;2014:815–824. http ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8487916/

Advanced Heart Failure Epidemiology and Outcomes Half of patients with advanced heart failure die within one year. Translational Outlook 1: Once patients develop advanced heart failure, outcomes are poor.

3. cfrjournal.com cfrjournal.com/articles/endpoints-heart-failure-drug-development?language_content_entity=en

Endpoints in Heart Failure Drug Development Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27599253/

CardioMEMS HF for the Management of Heart Failure ... CardioMEMS HF for the Management of Heart Failure-Effectiveness and Value.

5. researchgate.net researchgate.net/publication/382535417_Long-Term_Outcomes_of_Heart_Failure_With_Preserved_or_Mid-Range_Ejection_Fraction_in_the_United_States

Long-Term Outcomes of Heart Failure With Preserved ... Biomarkers in Heart Failure with Preserved Ejection Fraction: Problems and Opportunities. March 2017 · Cardiology. Filippos Triposkiadis.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06961929?locStr=United+States&country=United+States

Study Details | NCT06961929 | IEEM-Heat and Heart Failure Primary outcomes variables will be skin and core temperatures, while secondary variables will include measures of cardiovascular stress, myocardial perfusion, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4042428/

Cardiovascular responses to heat stress in chronic heart failure This review examines the effects of heat stress on cardiovascular and autonomic functions in patients with chronic heart failure (CHF).

8. cdc.gov cdc.gov/heat-health/hcp/clinical-overview/heat-and-people-with-cardiovascular-disease.html

Clinical Overview of Heat and Cardiovascular Disease Extremely hot temperatures have been associated with heart failure deaths. The combined effect of humidity and hot temperatures can affect blood ...

9. reidhealth.org reidhealth.org/blog/heat-and-congestive-heart-failure-a-dangerous-combination

Heat and congestive heart failure: a dangerous combination Exposure to high heat and humidity with congestive heart failure can cause you to overheat.

10. health.harvard.edu health.harvard.edu/blog/heart-problems-and-the-heat-what-to-know-and-do-202206212765

Heart problems and the heat: What to know and do High temperatures raise risk for heat exhaustion and heat stroke, and also stress the cardiovascular system, making the heart work harder.