Status:
COMPLETED
Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
Lead Sponsor:
Baylor College of Medicine
Conditions:
Heart Failure, Congestive
Metabolic Syndrome X
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure is a condition where the heart does not pump enough blood to the rest of the body. People with heart failure may have another condition called the "metabolic syndrome"( having excess fat...
Detailed Description
A striking feature of the Harris County Hospital District heart failure population is that the prevalence of obesity (50.8%) and the metabolic syndrome (48.9%) exceeds that of the general U.S. populat...
Eligibility Criteria
Inclusion
- Individuals with heart failure of ischemic or non-ischemic etiologies
- Age ≥18 years
- Admitted to the hospital with a primary diagnosis of heart failure (need not be their first admission for heart failure)
- Meets the modified Framingham criteria for the diagnosis of heart failure (2 major OR 1 major / 2 minor are required):
- MAJOR: paroxysmal nocturnal dyspnea (sudden shortness of breath at night), orthopnea (shortness of breath when supine), elevated jugular venous pressure, rales, the presence of an S3 heart sound, cardiomegaly on chest X-ray, pulmonary edema on chest X-ray
- MINOR: lower extremity edema, night cough, dyspnea on exertion, hepatomegaly, pleural effusion on chest X-ray, heart rate \> 120 bpm, weight loss \> 10 pounds in 5 days while in hospital
- • Meets the National Cholesterol Education Panel criteria for the metabolic syndrome (3 of 5 criteria must be present):
- waist \> 40 in for men, 35 in for women
- blood pressure ≥ 130/85 mmHg or hypertension
- triglycerides ≥150 mg/dL
- fasting glucose ≥ 100 mg/dL or diabetes
- high density lipoprotein level (HDL) \< 40 mg/dL for men, \<50 for women
Exclusion
- Patients will be excluded if they do not meet the definitions for heart failure and the metabolic syndrome listed above. Also, heart failure patients admitted for a diagnosis other than acute heart failure exacerbation will not be included. Other exclusion criteria include:
- A condition, other than heart failure, that limits a patient's survival (such as cancer, active hepatitis, advanced HIV infection etc.)
- Factors that may limit adherence to interventions or affect conduct of the trial
- Unable or unwilling to given informed consent
- Mental incapacity that limits patient's ability to live independently and benefit from patient education
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2015
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00293852
Start Date
February 1 2006
End Date
December 10 2015
Last Update
March 3 2020
Active Locations (1)
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1
Ben Taub General Hospital
Houston, Texas, United States, 77030