Pain Assessment, Incidence & Nature in Heart Failure (PAIN-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00444301
Recruitment Status : Completed
First Posted : March 7, 2007
Last Update Posted : June 11, 2008
Mayday Fund
National Institute on Aging (NIA)
Information provided by:

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 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.

Condition or disease
Heart Diseases

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 349 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Pain in Heart Failure Patients
Study Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with advanced heart failure

Inclusion Criteria:

  1. 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).

  2. 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.
  3. Can be awaiting LVAD, transplantation or other procedure
  4. Age > 18 years and able to sign informed consent to participate

Exclusion Criteria:

  1. Cognitive or other impairment which prevents accurate assessment of symptoms or ability to provide informed consent.
  2. Heart failure due to recent onset of acute viral myocarditis, peripartum myocarditis.
  3. Patient on hemodialysis or receiving mechanical ventilation
  4. Patients receiving investigational agents or devices.
  5. Patients who have received heart transplant or a destination Left Ventricular Assist Device

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00444301

United States, California
San Diego Hospice & Palliative Care
San Diego, California, United States, 92103
United States, District of Columbia
Washington DC VAMC Heart Failure Clinic
Washington, District of Columbia, United States, 20017
United States, Florida
Hospice of Palm Beach County
Palm Beach, Florida, United States, 33407
Lifepath Hospice & Palliative care
Tampa, Florida, United States, 33609
United States, Illinois
Bluhm Cardiovascular Institute
Chicago, Illinois, United States, 60611
United States, Kentucky
Unniversity of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Kaiser Mid-Atlantic States
Silver Spring, Maryland, United States, 20910
United States, Mississippi
Singing River Hospital System
Pascagoula, Mississippi, United States, 39581
United States, New York
Strong Memorial Congestive Heart Failure Program
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44193
United States, Pennsylvania
Hospice of Lancaster County/The Heart Group
Lancaster, Pennsylvania, United States, 17604
United States, Tennessee
Caris Health Care
Knoxville, Tennessee, United States, 37923
United States, Utah
The Heart Center
Holladay, Utah, United States, 84124
United States, Virginia
Capital Hospice
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Mayday Fund
National Institute on Aging (NIA)
Principal Investigator: Sarah J Goodlin, MD Patient-centered Education and Research

Additional Information:
Responsible Party: Sarah Goodlin MD/ Principal Investigator, Patient-centered Education and Research Identifier: NCT00444301     History of Changes
Other Study ID Numbers: 06-117PCER
First Posted: March 7, 2007    Key Record Dates
Last Update Posted: June 11, 2008
Last Verified: June 2008

Keywords provided by PC-HEART:
Heart failure
Advanced heart failure
Pain frequency, severity, location, treatments
Shortness of breath, anxiety, depression, cognitive function
Social support, other conditions and illnesses

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases