Collaborative Care for Heart Failure Patients With the Metabolic Syndrome

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Baylor College of Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00293852
First received: February 17, 2006
Last updated: December 2, 2010
Last verified: December 2010
  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:

  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Collaborative Care for Heart Failure Patients With the Metabolic Syndrome

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00293852     History of Changes
Other Study ID Numbers: H-18155
Study First Received: February 17, 2006
Last Updated: December 2, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Heart failure, Congestive
Metabolic Syndrome X
Ambulatory Care
Health behavior

Additional relevant MeSH terms:
Metabolic Syndrome X
Heart Failure
Syndrome
Heart Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014