Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | February 2006 |
| Contact: | Edith Beltran, LVN |
| Phone: | 281-952-3544 |
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.
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.
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
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
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
We found this trial at
1
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Ben Taub General Hospital Located in the heart of the Texas Medical Center, Ben Taub...
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