Collaborative Care for Heart Failure Patients With the Metabolic Syndrome - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00293852

Purpose

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:

fewer admissions to hospitals for illness
better blood pressure, sugar, fat and heart failure control
better patient satisfaction and knowledge about their diseases
lower levels of inflammation.

Condition	Intervention
Heart Failure, Congestive Metabolic Syndrome X	Procedure: Outpatient clinic follow-up

MedlinePlus related topics: Heart Failure Metabolic Syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Collaborative Care for Heart Failure Patients With the Metabolic Syndrome

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

- the number of rehospitalizations and emergency room visits for heart failure exacerbation

Secondary Outcome Measures:

- health care costs
- the achievement of goal doses of heart failure medications and target measures of the metabolic profile
- the change in levels of insulin resistance and inflammatory biomarkers
- overall patient satisfaction, disease understanding, and “self-management” skills

Estimated Enrollment:	380
Study Start Date:	February 2006

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. population. The metabolic syndrome is defined as the presence of 3 out of 5 components: abdominal obesity, elevated blood pressure, dyslipidemias (↑ triglycerides and ↓ high density lipoprotein) and insulin resistance and hyperglycemia. Current treatment recommendations for the metabolic syndrome include lifestyle modification (diet, exercise, and weight control) and targeted pharmaceutical therapy for the individual components. Although specialized care for the metabolic syndrome has not been reported, separately, both specialty heart failure care and endocrinology care have been shown to reduce hospital admissions and health care costs, increase target medication titration and disease control, improve quality of life, and survival in patients with heart failure and diabetes respectively. As both heart failure and the metabolic syndrome are commonly found in the same patients, collaborative out-patient management of both conditions in the same clinic is novel and may have a significant impact on outcomes.

Hypothesis:

Compared to usual post-discharge follow-up, collaborative treatment of heart failure patients with the metabolic syndrome by a team composed of an endocrinologist, cardiologist, patient educator, nurse and case manager will result in:

Decreased hospital readmissions and emergency room visits
Health care cost savings
Increased achievement of treatment goals (target blood pressure, HgbA1c, lipids, and heart failure medication titration)
Improved patient satisfaction, knowledge, and compliance
Lower levels of markers of inflammation and insulin resistance

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293852

Contacts

Contact: Edith Beltran, LVN

281-952-3544

Locations

United States, Texas
Ben Taub General Hospital	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Principal Investigator:	Allison M. Pritchett, M.D.	Baylor College of Medicine
Principal Investigator:	Ramaswami Nalini, M.B.B.S	Baylor College of Medicine
Principal Investigator:	Ashok Balasubramanyam, M.D.	Baylor College of Medicine

More Information

No publications provided

Study ID Numbers:	H-18155
Study First Received:	February 17, 2006
Last Updated:	February 17, 2006
ClinicalTrials.gov Identifier:	NCT00293852 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

Heart failure, Congestive
Metabolic Syndrome X
Ambulatory Care
Health behavior

Study placed in the following topic categories:

Hyperinsulinism
Heart Failure
Metabolic Diseases
Heart Diseases
Metabolic Syndrome X

Insulin Resistance
Glucose Metabolism Disorders
Metabolic Disorder
Abdominal Obesity Metabolic Syndrome

Additional relevant MeSH terms:

Hyperinsulinism
Heart Failure
Metabolic Diseases
Pathologic Processes
Disease
Heart Diseases

Metabolic Syndrome X
Syndrome
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009