- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00293852
Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Ben Taub General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
Experimental: Collaborative Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the number of rehospitalizations and emergency room visits for heart failure exacerbation
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
health care costs
Time Frame: 1 year
|
1 year
|
the achievement of goal doses of heart failure medications and target measures of the metabolic profile
Time Frame: 1 year
|
1 year
|
the change in levels of insulin resistance and inflammatory biomarkers
Time Frame: 1 year
|
1 year
|
overall patient satisfaction, disease understanding, and "self-management" skills
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-18155
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metabolic Syndrome X
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
-
Universidad de los Andes, ChileCompleted
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
Federal University of São PauloCompletedPhysical Activity | Endothelial Dysfunction | Metabolic Syndrome xBrazil
-
Midwest Biomedical Research FoundationSuspended
-
Instituto de Seguridad y Servicios Sociales de...Enrolling by invitationCardiovascular Diseases | Mediterranean Diet | Metabolic Syndrome xMexico
-
Wake Forest University Health SciencesBrigham and Women's HospitalCompletedDiabetes | Metabolic Syndrome xUnited States
-
University of PennsylvaniaAbbottCompletedMetabolic Syndrome xUnited States
-
Universidade Estadual Paulista Júlio de Mesquita...CompletedMetabolic Syndrome | Metabolic Syndrome XBrazil
-
University MariborSlovenian Research AgencyCompletedMetabolic Syndrome X
Clinical Trials on Outpatient clinic follow-up
-
University of New MexicoCompletedPostoperative Complications | Satisfaction | Pelvic Floor DisorderUnited States
-
Azienda Ospedaliera Cardinale G. PanicoUniversity of Campania "Luigi Vanvitelli"; Università Politecnica delle Marche and other collaboratorsCompleted
-
Azienda Ospedaliera Cardinale G. PanicoUnknown
-
Otto-von-Guericke University MagdeburgUniversity Hospital Regensburg; University of RegensburgCompletedCritical Illness | Post Intensive Care Syndrome | PICSGermany
-
Unity Health TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Mount...UnknownChronic Kidney Disease | Acute Kidney InjuryCanada
-
Tel-Aviv Sourasky Medical CenterAstraZenecaNot yet recruiting
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingCancer | Supportive CareUnited States
-
Chinese Academy of Medical Sciences, Fuwai HospitalWithdrawnMyocardial Ischemia | Heart Diseases | Coronary Artery Disease | Ischemic Heart Disease | Stable Chronic AnginaChina
-
University Hospitals Bristol and Weston NHS Foundation...CompletedPost Traumatic Stress DisorderUnited Kingdom
-
Stephen J. Teach, MD, MPHAmerican Academy of Allergy, Asthma, and Immunology; Robert Wood Johnson FoundationCompleted