Pain Assessment, Incidence & Nature in Heart Failure

Heart Diseases Clinical Trial

— PAIN-HF  

Official title:

Investigating Pain in Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444301
• Other study ID #: 06-117PCER
• Status: Completed
• Phase: Phase 0
• First received: March 5, 2007
• Last updated: June 8, 2008
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2008
• Source: PC-HEART
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Subjects will be recruited via physicians and nurses providing their care in clinical sites who are members of PC-HEART. PC-HEART is a volunteer collaborative with clinician-investigators at 60 sites nationally that include hospice organizations and heart failure providers in academic, Health Maintenance Organization (HMO) and community settings. Our goal will be to enroll 400 patients with 135 in hospice care and 265 in outpatient settings (a mix of HMO, community practice, VA, and academic centers) who are members of the Palliative Care- Heart Failure Education And Research Trials (PC-HEART) collaborative. We will strive for broad representation of patients living in the community with about one-third African American patients (who often present for initial treatment with advanced heart failure) and at least one-half elderly (who have high prevalence of both pain and heart failure).

We will use standardized tools to survey patients, as follows:

Pain & other symptoms (Assessed at enrollment and one-two weeks later):

Memorial Symptom Assessment Scale- HF (MSAS-HF) Short-form McGill pain questionnaire (SF-MPQ) Brief Pain Inventory (BPI)

Heart-failure specific measures (Assessed at Enrollment):

Kansas City Cardiomyopathy Questionnaire (KCCQ)

Psycho-social situation & cognitive function (Assessed at Enrollment):

Physicians Health Questionnaire depression screen (PHQ-9) Mini-cog Social functioning:

ENRICHD Social Support Inventory (ESSI) , The Short Physical Performance Battery (SPPB) will be collected on 1/2 of subjects Clinical Data (from medical record) Patient's medical condition: Charleson Comorbidity Scale, prior diagnosis of Diabetes Mellitus, Cancer, Chronic lung disease, Coronary Artery Disease, Cirrhosis.

Known painful conditions (osteoarthritis, chronic back pain, CAD with angina, neuropathy, others) Physical examination: Jugular Venous Pressure (as per NIH trial standards: base of neck, ½ way up, jaw level), edema (+1 (0-1/4" depression), +2 (1/4-1/2"), +3 (1/2-1"), +4 (>1")), Blood pressure, Respiratory rate, Heart rate & rhythm Echocardiogram data: Date of most recent Echocardiogram, LVEF, LVDD, LA dimension, presence of valvular disease & measure of severity (for example, if aortic stenosis then valve area, if mitral regurgitation then 1+-4+) Laboratory data: BUN, CR, Na+, HgB, BNP, hemoglobin

Demographic Data Age, Sex, Race & ethnic identification, Marital Status, Living situation (alone, with family, with other person), employment status (employed, self-employed, retired, unemployed due to disability), highest level of education, religious affiliation, annual household income, insurance (none, Medicare, Medicaid, Veterans Administration, Kaiser, other Health Maintenance Organization, private fee for service).

Medications & Treatment (Assessed at Enrollment and 1-2 weeks later) Heart Failure medications: ACEI, ARB, β-blocker, digoxin, spironolactone, eplerenone, loop diuretics, nesiritide, inotropes, warfarin Analgesics: NSAIDs, Cox-2 inhibitors, Aspirin, Acetaminophen, Tramadol, Opioids Antidepressants: SSRI, Tricyclics, Psychostimulants, other Topical agents: acetylsalicylate acid creams, capsaicin Physical therapy, cold, heat, other modalities Statistical Evaluation We will report frequencies of pain in total, frequencies of levels of severity & interference in activities of pain, by occasional versus frequent or constant pain, and by location with descriptive statistics. To the extent the etiology of pain is identified this will be reported with descriptive statistics. Pearson product-moment correlation coefficients, t-test and frequency statistics (Chi-square and Fisher's Exact test) will be used to evaluate associations between pain presence, severity and type and demographic and clinical variables. If possible, comparison will be made between patients without pain and those with pain using chi-square tests and t-test.

A multivariate analysis of variance will be used to assess relationship between pain and measures of heart failure severity, social support, depression and symptom distress other than pain.

Differences in Pain measures will be assessed between enrollment and the second assessment 1-2 weeks later, and changes will be correlated with changes in treatment for pain. Geographic locations of pain will be mapped using the body diagram on the BPI to identify areas of greatest frequency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 + ß-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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Diseases
• Heart Failure

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
PC-HEART	Mayday Fund, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

External Links

•   This is the PC-HEART website