Collaborative Care for Heart Failure Patients With the Metabolic Syndrome

Completed · Not applicable

Conditions studied: Heart Failure, Congestive, Metabolic Syndrome X

In brief

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 in the belly, high blood pressure, high fat in the blood, low level of good cholesterol and high blood sugar). People who have both heart failure and the metabolic syndrome often see many doctors. A new clinic has been formed at Ben Taub General Hospital that includes a specialist in heart failure (cardiologist) and in the metabolic syndrome (endocrinologist) as well as patient teaching. The goal of this study is to randomize patients with the metabolic syndrome who are admitted to the hospital for heart failure to this clinic (collaborative care) versus the usual doctor appointments (usual care). The purpose of this study is to see if collaborative care is better medical care than usual care. Specifically, we will see if patients in collaborative care will have: 1. fewer admissions to hospitals for illness 2. better blood pressure, sugar, fat and heart failure control 3. better patient satisfaction and knowledge about their diseases 4. lower levels of inflammation.

Key facts

Study ID

NCT00293852

Run by

Baylor College of Medicine

People needed

114

Starts

2006-02-01

Expected to finish

2015-12-10

Last updated by the study team

2020-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Ben Taub General Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.