Mental Stress for Heart Failure

Recruiting at 2 trial locations

Overseen By Sara Tabtabai, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Opioids

Disqualifiers: Class IV heart failure, Dialysis, others

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

Compensation: Varies

Number of Visits: 1

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mental stress might affect individuals with congestive heart failure (CHF). Researchers aim to determine if stress can trigger worsening symptoms in those with CHF. Participants will experience mental stress in both a lab setting and their daily life to observe its impact on their heart. The trial seeks heart failure patients who have or will receive a specific heart pressure monitor implant. As an unphased trial, this study offers patients a unique opportunity to contribute to understanding stress's impact on heart health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you use chronic opioids, you cannot participate in the trial.

What prior data suggests that this mental stress protocol is safe for heart failure patients?

Research shows that mental stress can affect heart health, especially in individuals with heart disease. Some studies suggest that stress might worsen heart failure symptoms by impacting heart function. However, strong evidence does not exist to show that mental stress alone directly harms the heart in a dangerous way.

In individuals with heart failure, mental health issues like anxiety and depression are common, affecting up to 50% of patients. These issues can sometimes lead to worse heart health. Past research has focused more on managing these mental health conditions to improve overall heart health.

While mental stress is not a medication or physical treatment, studying its effects on heart failure is important. Understanding its role in heart health can be beneficial. No evidence shows that the mental stress used in studies has caused severe problems. However, managing stress in heart failure patients can be crucial to improving their health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Mental Stress for Heart Failure" trial because it explores how psychological stress and negative emotions might impact heart failure in a new way. Unlike standard treatments for heart failure, which typically focus on medications, lifestyle changes, or surgical interventions, this approach uses mental stress as a tool to understand its effects on heart function. By using a lab-based mental stress protocol and ecological momentary assessment (EMA), researchers aim to uncover how stress influences pulmonary artery pressure in real-time, potentially leading to innovative strategies for managing heart failure.

What evidence suggests that mental stress could precipitate heart failure exacerbation?

Research has shown that mental stress greatly affects people with heart failure. Studies have found that heart failure patients experiencing high stress often have worse health and a lower quality of life. Blood pressure typically rises during mental stress, leading to negative effects for these patients. Additionally, anxiety and depression are common in heart failure and link to a higher risk of serious health issues. This trial will test the effects of psychological stress and negative emotions on heart failure patients, suggesting that managing stress might be important for improving their health. ^{3 6 7 8 9}

Who Is on the Research Team?

Rachel Lampert, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for heart failure patients over 18 with a Cardiomems PAP monitor. It's not for those on chronic opioids, with disabilities preventing assessments, other conditions affecting PA pressures, physical limitations to participate, non-compliance with PAP monitoring or Class IV heart failure.

Inclusion Criteria

I am over 18 with heart failure and have or will get a Cardiomems PAP monitor.

Exclusion Criteria

I have a condition affecting my lung blood pressure that is not heart failure.

I do not have the most severe form of heart failure.

Patients with physical conditions that interfere with study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Laboratory Component

Participants undergo a laboratory mental stress protocol including resting, relaxation, stress, and recovery periods with PAP and blood pressure assessments.

1 day

1 visit (in-person)

Field Component

Participants complete daily PAP assessments and eDiary-based EMA for six months, with additional evening assessments for one month.

6 months

Follow-up

Clinical outcomes are determined through review of the Cardiomems Merlin database and medical record review.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mental Stress

Trial Overview The study aims to see if acute stress can worsen congestive heart failure in patients. Participants will undergo mental stress tests while their cardiac responses are monitored using the implanted PAP device.

How Is the Trial Designed?

Group I: Mental Stress Experimental Treatment 1 Intervention

Patients will undergo a lab mental stress protocol, and a field protocol using ecological momentary assessment (EMA) to test the effects of psychological stress and negative emotion on PAP in HF patients.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 77 hospitalized patients with Chronic Heart Failure (CHF), a significant portion exhibited emotional disorders, with 26% showing anxiety symptoms and 25% experiencing severe depression, highlighting the need for psychological support in this population.

The research found that dispositional pessimism was negatively correlated with patients' perceptions of treatment control and coherence, suggesting that pessimism may influence how patients manage their illness, warranting further investigation into its role in disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Perception of illness and dispositional optimism in a sample of patients with chronic heart failure]. Giardini, A., Pierobon, A., Majani, G., et al.[2015]

In a study of 144 heart failure patients, those with consistently high levels of perceived psychological stress were found to have a greater likelihood of experiencing adverse cardiovascular events, such as hospitalizations and death, with an odds ratio of 1.10.

The research suggests that sustained psychological stress is a significant risk factor for adverse events in heart failure patients, indicating that targeting stress management could be a valuable intervention to reduce hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological stress and short-term hospitalisations or death in patients with heart failure. Endrighi, R., Waters, AJ., Gottlieb, SS., et al.[2019]

In a study of 24 heart failure patients with reduced ejection fraction, mental stress was found to significantly worsen left ventricular (LV) diastolic pressure, particularly in those who experienced stress-induced increases in the E/e' ratio.

The research indicated that higher levels of anger reported in the week prior to stress testing were associated with worse resting LV diastolic pressure, suggesting that emotional stressors may have long-term implications for heart function in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Mental Stress and Anger on Indices of Diastolic Function in Patients With Heart Failure. Harris, KM., Gottdiener, JS., Gottlieb, SS., et al.[2021]

In a study of 107 patients with stable chronic heart failure, heart-focused anxiety was primarily predicted by self-reported anxiety levels and quality of life, highlighting the importance of psychological factors in these patients.

Additionally, factors such as conscientiousness, physical activity, and renal function (measured by estimated glomerular filtration rate, eGFR) were also found to be significant predictors of heart-focused anxiety, suggesting that both lifestyle and medical indicators can help identify patients at risk for adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of heart-focused anxiety in patients with stable heart failure. Wedegärtner, SM., Schwantke, I., Kindermann, I., et al.[2021]

Stress management interventions (SMIs) for adults with heart failure showed significant short-term improvements in anxiety, depressive symptoms, disease-specific quality of life, and exercise capacity, based on a meta-analysis of 23 randomized controlled trials involving 2,294 participants.

While SMIs were effective immediately after the intervention, these benefits did not persist at follow-up, indicating a need for longer-term studies to better understand the lasting impact of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress management interventions for adults with heart failure: Systematic review and meta-analysis. Gathright, EC., Salmoirago-Blotcher, E., DeCosta, J., et al.[2022]

In a study of 111 chronic heart failure patients, severe anxiety was found to significantly predict hospital readmission, indicating that psychological factors can influence healthcare utilization.

While no psychological variables were linked to mortality, factors like vital exhaustion and anxiety were shown to impact health-related quality of life, suggesting the importance of assessing these variables in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of readmission and health related quality of life in patients with chronic heart failure: a comparison of different psychosocial aspects. Volz, A., Schmid, JP., Zwahlen, M., et al.[2021]

In a study of 25,785 participants over a median follow-up of 10.1 years, higher perceived stress levels were linked to an increased risk of developing heart failure with preserved ejection fraction, but not heart failure with reduced ejection fraction.

The association between perceived stress and heart failure was less pronounced in individuals taking statins, suggesting that statins may have a protective effect against stress-related heart failure risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Perceived Stress With Incident Heart Failure. Balkan, L., Ringel, JB., Levitan, EB., et al.[2023]

Psychosocial interventions for patients with chronic heart failure show some short-term benefits in reducing depression and anxiety, as well as improving quality of life, based on a meta-review of seven systematic reviews encompassing 67 original studies.

However, the long-term effects of these interventions are not well-studied, indicating a need for further research to explore sustained benefits and the incorporation of clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-review of systematic reviews and meta-analyses on outcomes of psychosocial interventions in heart failure. Nahlén Bose, C.[2023]

In a study of 103 patients with chronic heart failure, over half (52.4%) reported symptoms of depression, highlighting a significant mental health concern in this population.

The study identified that higher scores on the Minnesota Living with Heart Failure Questionnaire and poorer performance on the six-minute walk test were independent predictors of depression, suggesting that mental health screening should be a routine part of care for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of depression, stress and anxiety symptoms in patients with chronic heart failure. Tsabedze, N., Kinsey, JH., Mpanya, D., et al.[2021]

Patients with heart failure often experience high levels of psychological stress, which can worsen their disease progression and lead to a lower quality of life, highlighting the importance of managing stress in this population.

Understanding the specific stressors related to heart failure and their effects on symptoms could help identify at-risk patients and improve treatment strategies, as stress is a modifiable factor that may enhance patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological stress in heart failure: a potentially actionable disease modifier. Harris, KM., Jacoby, DL., Lampert, R., et al.[2022]

In a study of 238 heart failure patients, both baseline depression and anxiety, as well as increases in these conditions over 6 months, were found to independently predict a decline in physical functioning.

Social support did not show a significant relationship with physical functioning, indicating that mental health factors like depression and anxiety are more critical in influencing physical health outcomes in heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression and anxiety predict decline in physical health functioning in patients with heart failure. Shen, BJ., Eisenberg, SA., Maeda, U., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8026548/

Psychological Stress in Heart Failure: A Potentially ... Emerging evidence suggests that heart failure patients who experience higher levels of stress may have a more burdensome disease course, with diminished quality ...

2. ahajournals.org ahajournals.org/doi/full/10.1161/JAHA.124.034683

Cardiovascular Reactivity to Mental Stress and Adverse ... Blood pressure reactivity to psychological stress is associated with clinical outcomes in patients with heart failure. Am Heart J. 2017;191 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146280623004048

Anxiety and Depression in Heart Failure: An Updated Review Studies have estimated the prevalence of anxiety in heart failure to range from 20% to 50%, while the prevalence of depression ranges from 20% to 45%.4 These ...

4. jacc.org jacc.org/doi/10.1016/j.jacadv.2023.100794

Psychological Distress and the Risk of Adverse ... A composite measure of psychological distress was significantly associated with an increased risk of adverse events and significantly improved risk prediction.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9225328/

Mental Stress and Cardiovascular Health—Part I - PMC Mental stress is an emerging risk and prognostic factor for coronary artery disease and stroke, independently of conventional risk factors.

6. nhlbi.nih.gov nhlbi.nih.gov/news/2025/risk-score-offers-new-way-assess-impact-stress-can-have-heart

Risk score offers new way to assess the impact that stress can ... Risk score gauges toll that mental stress can have on the heart. People with heart disease who had a less adaptive cardiovascular response ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031117

Impact of Mental Health Treatment on Outcomes in Patients ... These findings indicate that mental health interventions are essential to reducing hospitalizations and ED visits in patients with HF or ...

8. ijmhs.biomedcentral.com ijmhs.biomedcentral.com/articles/10.1186/s13033-021-00467-x

The prevalence of depression, stress and anxiety symptoms in ... Potential mechanisms linking depression and anxiety with poor heart failure outcomes include inflammation, autonomic dysfunction, enhanced ...

9. jacc.org jacc.org/doi/10.1016/j.jacc.2022.06.017

Severe Mental Illness and Cardiovascular Disease People with severe mental illness, consisting of schizophrenia, bipolar disorder, and major depression, have a high burden of modifiable cardiovascular risk ...