NCT00444301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 11, 2008

Status Verified

June 1, 2008

Enrollment Period

1.5 years

First QC Date

March 5, 2007

Last Update Submit

June 8, 2008

Conditions

Heart Diseases

Keywords

Heart failurePainSymptomsAdvanced heart failurePain frequency, severity, location, treatmentsShortness of breath, anxiety, depression, cognitive functionSocial support, other conditions and illnesses

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with advanced heart failure

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

San Diego Hospice & Palliative Care

San Diego, California, 92103, United States

Location

Washington DC VAMC Heart Failure Clinic

Washington D.C., District of Columbia, 20017, United States

Location

Hospice of Palm Beach County

Palm Beach, Florida, 33407, United States

Location

Lifepath Hospice & Palliative care

Tampa, Florida, 33609, United States

Location

Bluhm Cardiovascular Institute

Chicago, Illinois, 60611, United States

Location

Unniversity of Kentucky

Lexington, Kentucky, 40536, United States

Location

Kaiser Mid-Atlantic States

Silver Spring, Maryland, 20910, United States

Location

Singing River Hospital System

Pascagoula, Mississippi, 39581, United States

Location

Strong Memorial Congestive Heart Failure Program

Rochester, New York, 14642, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44193, United States

Location

Hospice of Lancaster County/The Heart Group

Lancaster, Pennsylvania, 17604, United States

Location

Caris Health Care

Knoxville, Tennessee, 37923, United States

Location

The Heart Center

Holladay, Utah, 84124, United States

Location

Capital Hospice

Falls Church, Virginia, 22042, United States

Location

Related Links

MeSH Terms

Conditions

Heart DiseasesHeart FailurePainDyspneaAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratoryMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Sarah J Goodlin, MD

    Patient-centered Education and Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2007

First Posted

March 7, 2007

Study Start

June 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 11, 2008

Record last verified: 2008-06

Locations

US(14)