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Collaborative Care for Heart Failure Patients With the Metabolic Syndrome

Primary Purpose

Heart Failure, Congestive, Metabolic Syndrome X

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Outpatient clinic follow-up
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Heart failure, Congestive, Metabolic Syndrome X, Ambulatory Care, Health behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ben Taub General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Collaborative Care

Arm Description

Outcomes

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

Full Information

First Posted
February 17, 2006
Last Updated
February 28, 2020
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00293852
Brief Title
Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
Official Title
Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 14, 2009 (Actual)
Study Completion Date
December 10, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

5. Study Description

Brief 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: 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Metabolic Syndrome X
Keywords
Heart failure, Congestive, Metabolic Syndrome X, Ambulatory Care, Health behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Title
Collaborative Care
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Outpatient clinic follow-up
Primary Outcome Measure Information:
Title
the number of rehospitalizations and emergency room visits for heart failure exacerbation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
health care costs
Time Frame
1 year
Title
the achievement of goal doses of heart failure medications and target measures of the metabolic profile
Time Frame
1 year
Title
the change in levels of insulin resistance and inflammatory biomarkers
Time Frame
1 year
Title
overall patient satisfaction, disease understanding, and "self-management" skills
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison M. Pritchett, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramaswami Nalini, M.B.B.S
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashok Balasubramanyam, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Collaborative Care for Heart Failure Patients With the Metabolic Syndrome

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