Clinical trial NCT00444301: Pain Assessment, Incidence & Nature in Heart Failure
Official title: Investigating Pain in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Diseases
Keywords: 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
Lead sponsor: PC-HEART
Sponsor class: OTHER
Collaborators: name: Mayday Fund
name: National Institute on Aging (NIA)
First posted: 2007-03-07
Enrollment: 349
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with advanced heart failure

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.

Detailed 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Hospice & Palliative Care
state: California
city: Washington
country: United States
facility: Washington DC VAMC Heart Failure Clinic
state: District of Columbia
city: Palm Beach
country: United States
facility: Hospice of Palm Beach County
state: Florida
city: Tampa
country: United States
facility: Lifepath Hospice & Palliative care
state: Florida
city: Chicago
country: United States
facility: Bluhm Cardiovascular Institute
state: Illinois
city: Lexington
country: United States
facility: Unniversity of Kentucky
state: Kentucky
city: Silver Spring
country: United States
facility: Kaiser Mid-Atlantic States
state: Maryland
city: Pascagoula
country: United States
facility: Singing River Hospital System
state: Mississippi
city: Rochester
country: United States
facility: Strong Memorial Congestive Heart Failure Program
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Lancaster
country: United States
facility: Hospice of Lancaster County/The Heart Group
state: Pennsylvania
city: Knoxville
country: United States
facility: Caris Health Care
state: Tennessee
city: Holladay
country: United States
facility: The Heart Center
state: Utah
city: Falls Church
country: United States
facility: Capital Hospice
state: Virginia
Study officials:
affiliation: Patient-centered Education and Research
name: Sarah J Goodlin, MD
role: PRINCIPAL_INVESTIGATOR
References: