Heart Failure, CongestiveNCT00293852
Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
A study testing Outpatient clinic follow-up in people with Heart Failure, Congestive and Metabolic Syndrome X, run by Baylor College of Medicine at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive, Metabolic Syndrome X
- What is being tested?
- Outpatient clinic follow-up
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to 10 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Heart Failure, Congestive, Metabolic Syndrome X
- Being tested
- Outpatient clinic follow-up
- Keywords
- Heart failure, Congestive, Metabolic Syndrome X, Ambulatory Care, Health behavior
- Medical subject headings
- Heart Failure, Metabolic Syndrome, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient clinic follow-upProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| Collaborative Care | Experimental | Not described Receives: Procedure: Outpatient clinic follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of rehospitalizations and emergency room visits for heart failure exacerbation
Measured: 1 year
Secondary outcomes (4)
health care costs
Measured: 1 year
the achievement of goal doses of heart failure medications and target measures of the metabolic profile
Measured: 1 year
the change in levels of insulin resistance and inflammatory biomarkers
Measured: 1 year
overall patient satisfaction, disease understanding, and "self-management" skills
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completion14 Oct 2009
- Study completion10 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, CongestiveStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Pritchett, Baylor College of Medicine
- Investigators
- Allison M. Pritchett, M.D., Principal investigator, Baylor College of MedicineRamaswami Nalini, M.B.B.S, Principal investigator, Baylor College of MedicineAshok Balasubramanyam, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293852
- Sponsor's protocol ID
- H-18155
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2006
- Last updated
- 3 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Heart Failure Patients With the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT00293852
- Acronym / sponsor ID
- H-18155
- Conditions
- Heart Failure, Congestive, Metabolic Syndrome X
- Keywords
- Heart failure, Congestive, Metabolic Syndrome X, Ambulatory Care, Health behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- 14 Oct 2009 (actual)
- Study completion
- 10 Dec 2015 (actual)
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | – |
| Collaborative Care | Experimental | Procedure: Outpatient clinic follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient clinic follow-up | Procedure or surgery | Collaborative Care |
Primary outcome
the number of rehospitalizations and emergency room visits for heart failure exacerbation
Time frame: 1 year
4 secondary outcomes
health care costs
Time frame: 1 year
the achievement of goal doses of heart failure medications and target measures of the metabolic profile
Time frame: 1 year
the change in levels of insulin resistance and inflammatory biomarkers
Time frame: 1 year
overall patient satisfaction, disease understanding, and "self-management" skills
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison M. Pritchett, M.D. principal investigator
Baylor College of Medicine
Ramaswami Nalini, M.B.B.S principal investigator
Baylor College of Medicine
Ashok Balasubramanyam, M.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient clinic follow-up in people with Heart Failure, Congestive and Metabolic Syndrome X, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of rehospitalizations and emergency room visits for heart failure exacerbation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.