Stress and Congestive Heart Failure

ConditionCongestive Heart Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorYale University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Mental Stress
Other 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.

Treatment groups

112 Participants

are divided into 1 treatment group

Group A: Mental StressOther 1 intervention

Trial outcomes

Primary outcomes

Pulmonary Artery Pressure

Pulmonary artery pressure as measured by an implanted monitor: Pulmonary artery pressure will be compared between times of stress and calm, in both the laboratory and real-life setting.

Time frame

6 months

Secondary outcomes

Medication changes

Will be compared between those with highest levels of stress-triggered PA increases, and those with lower

Time frame

6 months

Other outcomes

Number of participants that are hospitalized

Hospitalizations will be compared between those with highest levels of stress-triggered PA increases, and those with lower

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yale University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

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