Pain Assessment, Incidence & Nature in Heart Failure

Completed

Conditions studied: Heart Diseases

In brief

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 presence of pain. The cause of pain for these persons is not clear. PAIN-HF (Pain Assessment, Incidence \& Nature in Heart Failure), conducted through the Palliative Care-Heart Failure Education And Research Trials (PC-HEART) collaborative will identify the prevalence of pain, its location, severity and impact on activities and the possible causes of pain in persons living with heart failure. The study will also try to understand relationships between other problems and pain, as well as what treatments are given to reduce pain. Understanding sources of pain and its characteristics is the first step in helping health care providers better manage pain and related problems in persons with heart failure.

Key facts

Study ID

NCT00444301

Run by

PC-HEART

People needed

349

Starts

2006-06-01

Expected to finish

2007-12-01

Last updated by the study team

2008-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Diego Hospice & Palliative Care — San Diego, California, United States
• Washington DC VAMC Heart Failure Clinic — Washington D.C., District of Columbia, United States
• Hospice of Palm Beach County — Palm Beach, Florida, United States
• Lifepath Hospice & Palliative care — Tampa, Florida, United States
• Bluhm Cardiovascular Institute — Chicago, Illinois, United States
• Unniversity of Kentucky — Lexington, Kentucky, United States
• Kaiser Mid-Atlantic States — Silver Spring, Maryland, United States
• Singing River Hospital System — Pascagoula, Mississippi, United States
• Strong Memorial Congestive Heart Failure Program — Rochester, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Hospice of Lancaster County/The Heart Group — Lancaster, Pennsylvania, United States
• Caris Health Care — Knoxville, Tennessee, United States
• The Heart Center — Holladay, Utah, United States
• Capital Hospice — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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