Collaborative Care for Heart Failure Patients With the Metabolic Syndrome

Heart Failure, Congestive Clinical Trial

Official title:

Collaborative Care for Heart Failure Patients With the Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293852
• Other study ID #: H-18155
• Status: Completed
• Phase: N/A
• Start date: February 2006
• Est. completion date: December 10, 2015

Study information

• Verified date: February 2020
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: December 10, 2015
• Est. primary completion date: October 14, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Procedure:
• Outpatient clinic follow-up

Locations

Country	Name	City	State
United States	Ben Taub General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of rehospitalizations and emergency room visits for heart failure exacerbation		1 year
Secondary	health care costs		1 year
Secondary	the achievement of goal doses of heart failure medications and target measures of the metabolic profile		1 year
Secondary	the change in levels of insulin resistance and inflammatory biomarkers		1 year
Secondary	overall patient satisfaction, disease understanding, and "self-management" skills		1 year