Status:
COMPLETED
Pain Assessment, Incidence & Nature in Heart Failure
Lead Sponsor:
PC-HEART
Collaborating Sponsors:
Mayday Fund
National Institute on Aging (NIA)
Conditions:
Heart Diseases
Eligibility:
All Genders
18+ years
Brief Summary
Heart failure, a chronic illness afflicting 5 million persons in the United States is known to cause shortness of breath and fatigue, yet at least half of persons with heart failure also report the pr...
Detailed Description
Subjects will be recruited via physicians and nurses providing their care in clinical sites who are members of PC-HEART. PC-HEART is a volunteer collaborative with clinician-investigators at 60 sites ...
Eligibility Criteria
Inclusion
- Advanced HF (Stage D or advanced Stage C HF) with:
- symptoms of dyspnea at rest or with minimal exertion systolic dysfunction or preserved systolic function ("diastolic heart failure") Outpatient care setting (office, clinic or home hospice).
- Patient already receiving optimal medical therapy per ACC/AHA guidelines (ACEI or ARB + β-blocker +aldosterone antagonist) for at least 1 month or explanation of intolerance of specific medication. We will exclude those not on optimized medications with no notation of intolerance; however, we will keep a tally to quantify patients who are considered "advanced Heart Failure" but are not on recommended medications.
- Can be awaiting LVAD, transplantation or other procedure
- Age \> 18 years and able to sign informed consent to participate
Exclusion
- Cognitive or other impairment which prevents accurate assessment of symptoms or ability to provide informed consent.
- Heart failure due to recent onset of acute viral myocarditis, peripartum myocarditis.
- Patient on hemodialysis or receiving mechanical ventilation
- Patients receiving investigational agents or devices.
- Patients who have received heart transplant or a destination Left Ventricular Assist Device
Key Trial Info
Start Date :
June 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
349 Patients enrolled
Trial Details
Trial ID
NCT00444301
Start Date
June 1 2006
End Date
December 1 2007
Last Update
June 11 2008
Active Locations (14)
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1
San Diego Hospice & Palliative Care
San Diego, California, United States, 92103
2
Washington DC VAMC Heart Failure Clinic
Washington D.C., District of Columbia, United States, 20017
3
Hospice of Palm Beach County
Palm Beach, Florida, United States, 33407
4
Lifepath Hospice & Palliative care
Tampa, Florida, United States, 33609