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Mental Stress for Heart Failure

N/A

Recruiting

Led By Rachel Lampert, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Heart failure patients over 18 who have or will be receiving a Cardiomems implanted PAP monitor.

Be older than 18 years old

Must not have

Patients with conditions other than heart failure that affect PA pressures (e.g. dialysis).

Patients with Class IV heart failure will also be excluded, as they are already maximally decompensated, and a ceiling/floor effect would preclude effects of stress.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether stress can make heart failure worse in people who already have the condition.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves mental stress tests rather than medication or invasive procedures, side effects may include temporary increases in anxiety or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pulmonary Artery Pressure

Secondary study objectives

Medication changes

Other study objectives

Number of participants that are hospitalized

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mental StressExperimental Treatment1 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.

0 / 3Eligibility criteria met