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

This study has been completed.

Sponsors and Collaborators: PC-HEART
The Mayday Fund
National Institute on Aging (NIA)
Information provided by: PC-HEART
ClinicalTrials.gov Identifier: NCT00444301
  Purpose

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 Phase
Heart Diseases
Phase 0

MedlinePlus related topics:   Heart Diseases    Heart Failure    Palliative Care   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Investigating Pain in Heart Failure Patients

Further study details as provided by PC-HEART:

Enrollment:   349
Study Start Date:   June 2006
Study Completion Date:   December 2007
Primary Completion Date:   December 2007 (Final data collection date for primary outcome measure)

Show detailed description  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Adult patients with advanced heart failure


Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00444301

Locations
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
PC-HEART
The Mayday Fund
National Institute on Aging (NIA)

Investigators
Principal Investigator:     Sarah J Goodlin, MD     Patient-centered Education and Research    
  More Information


This is the PC-HEART website  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Patient-centered Education and Research ( Sarah Goodlin MD/ Principal Investigator )
Study ID Numbers:   06-117PCER
First Received:   March 5, 2007
Last Updated:   June 8, 2008
ClinicalTrials.gov Identifier:   NCT00444301
Health Authority:   United States: Institutional Review Board

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

Study placed in the following topic categories:
Heart Failure
Depression
Heart Diseases
Pain
Depressive Disorder
Dyspnea

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 31, 2008




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