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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pulmonary Artery Pressure

Secondary outcome measures

Medication changes

Other outcome measures

Number of participants that are hospitalized

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,737,706 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,786 Total Patients Enrolled

Rachel Lampert, MDPrincipal InvestigatorYale University

3 Previous Clinical Trials

4,703 Total Patients Enrolled

Media Library

Mental Stress Clinical Trial Eligibility Overview. Trial Name: NCT04551560 — N/A

Congestive Heart Failure Research Study Groups: Mental Stress

Congestive Heart Failure Clinical Trial 2023: Mental Stress Highlights & Side Effects. Trial Name: NCT04551560 — N/A

Mental Stress 2023 Treatment Timeline for Medical Study. Trial Name: NCT04551560 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being enrolled in this trial?

"According to the information presented on clinicaltrials.gov, this is a live trial that was first opened for applications on October 7th 2020 and most recently updated on August 18th 2022."

Answered by AI

What is the current intake cap for participants in this clinical investigation?

"Affirmative. Upon inspection of the clinicaltrials.gov website, it is evident that this experiment has been actively recruiting since October 7th 2020 and remains open for applications after its August 18th 2022 update. 112 patients are required to be recruited from two different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stress and Congestive Heart Failure

2020. "Stress and Congestive Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04551560.

All > Congestive Heart Failure