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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate whether acute stress can precipitate congestive heart failure (CHF) exacerbation in patients with CHF.

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.

Is mental stress safe for people with heart failure?

Research suggests that mental stress can worsen heart function and increase the risk of adverse events in people with heart failure, indicating potential safety concerns. ^{1 2 3 4 5}

How does this treatment for heart failure differ from other treatments?

This treatment focuses on managing mental stress, which is unique because it addresses psychological factors that can worsen heart failure symptoms. Unlike traditional treatments that primarily target physical symptoms, this approach considers stress as a modifiable factor that can improve quality of life and outcomes for heart failure patients. ^{2 3 6 7 8}

What data supports the effectiveness of the treatment Mental Stress, Psychological Stress, Emotional Stress, Anxiety for heart failure?

Research suggests that managing psychological stress can improve quality of life and reduce anxiety and depressive symptoms in heart failure patients. Stress management interventions are increasingly recommended as they may help improve exercise capacity and disease-specific quality of life. ^{2 3 9 10 11}

Research Team

Rachel Lampert, MD

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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 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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Psychological stress in heart failure: a potentially actionable disease modifier. [2022]

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

Impact of Mental Stress and Anger on Indices of Diastolic Function in Patients With Heart Failure. [2021]

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

Stress management interventions for adults with heart failure: Systematic review and meta-analysis. [2022]

5. United States 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. [2021]

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

Psychological stress and short-term hospitalisations or death in patients with heart failure. [2019]

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

Association of Perceived Stress With Incident Heart Failure. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of heart-focused anxiety in patients with stable heart failure. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Depression and anxiety predict decline in physical health functioning in patients with heart failure. [2022]

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

The prevalence of depression, stress and anxiety symptoms in patients with chronic heart failure. [2021]

11. Italy pubmed.ncbi.nlm.nih.gov

[Perception of illness and dispositional optimism in a sample of patients with chronic heart failure]. [2015]