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Heart failure patients: does stress make it worse?

NCT ID NCT04551560

Knowledge-focused Sponsor: Yale University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times

Summary

This study looks at whether acute stress can cause sudden worsening of congestive heart failure. Researchers will monitor 112 heart failure patients who have an implanted device that measures pressure in the lung artery. They will compare pressure readings during stressful and calm moments, both in the lab and in daily life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help identify stress as a trigger for heart failure flare-ups, leading to better management strategies.
What could go wrong
This is an observational study, not a treatment trial. It may not prove a direct cause-and-effect link, and results may not apply to all heart failure patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

108 people

The number who actually took part.

Started

Dec 2020

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: -Heart failure patients over 18 who have or will be receiving a Cardiomems implanted PAP monitor. Exclusion Criteria: * Patients who are unable to perform EMA or laboratory assessments due to cognitive, visual, language, or other disabilities will be excluded. * 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. * Patients with conditions other than heart failure that affect PA pressures (e.g. dialysis). * Patients with physical conditions that interfere with study participation. * Patients non-compliant with their PAP monitoring. * Patients with chronic opioid use will be excluded.

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congestive heart failure

Contacts and locations

Locations

  • St. Francis Hospital

    Hartford, Connecticut, 06105, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

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