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

This study has been completed.
Sponsor:
Collaborators:
Mayday Fund
Information provided by:
PC-HEART
ClinicalTrials.gov Identifier:
NCT00444301
First received: March 5, 2007
Last updated: June 8, 2008
Last verified: June 2008
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating Pain in Heart Failure Patients

Resource links provided by NLM:


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

  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
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

Responsible Party: Sarah Goodlin MD/ Principal Investigator, Patient-centered Education and Research
ClinicalTrials.gov Identifier: NCT00444301     History of Changes
Other Study ID Numbers: 06-117PCER
Study First Received: March 5, 2007
Last Updated: June 8, 2008
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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014