- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05531214
Creating A Cardiorenal Multidisciplinary Team for Management HF and CKD Patients
A Comparative Effectiveness Study to Assess the Impact of a Multidisciplinary Cardiorenal Care Team to Assist Primary Care Clinicians in Managing Patients With Heart Failure and Chronic Kidney Disease vs Usual Care.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Major advancements have occurred in guideline-directed medical therapies (GDMT) for heart failure (HF) over the last decade. Various classes of drugs including beta-adrenergic receptor blockers, renin-angiotensin system inhibitors, sodium-glucose co-transporter inhibitors, etc. have demonstrated significant improvement in the quality of life, prevention of recurrent hospitalizations for HF, and reduction in overall morbidity and mortality. However, despite the billions of healthcare dollars and additional clinical resources invested into developing these evidence-based treatment regimens, a substantial proportion of the affected patient populations remains undertreated worldwide rendering GDMT unrealistic to implement broadly, particularly in the subgroup of patients with concomitant chronic kidney disease (CKD).
Several deterrents contribute to the low implementation rates of GDMT in HF with CKD including clinicians' therapeutic inertia and fear of inducing harm, poor coordination of care between inpatient and outpatient titration of medications, fragmented healthcare models, inaccessibility to specialists' support, and high-cost burden deeming certain medications unaffordable. These factors also primarily affect minority communities, patients among the lower socioeconomic strata, and individuals with limited health literacy who are unequally affected by higher rates of HF with CKD. Although current research can both qualify and quantify the benefits of the medications, minimal treatment prototypes exist to ensure that patients have and maintain access to these therapies, the frequent follow-up visits, and the surveillance screenings required to monitor long-term symptoms and potential medication side-effects.
This study aims to compare the effects of a co-localized multidisciplinary cardiorenal team supporting a primary care clinician versus the traditional referral-based care model, on the implementation rates of GDMT in patients with specifically heart failure with reduced ejection fraction (HFrEF) and CKD. Investigators will conduct a single-center pragmatic randomized controlled trial that will compare the following approaches:
1. Co-localized care with a telemedicine-based cardiorenal multidisciplinary team (cardiologist, nephrologist, and research coordinators) providing guidance and recommendations to the primary care clinician 2. A control group of usual care with a primary care clinician making referrals to a cardiologist or nephrologist "for-cause" as determined by the primary care clinician, to ultimately assess the rates of improvement in the implementation of GDMT. The research coordinators will also play a crucial role in identifying financial barriers, circumventing insurance and prior authorization issues, as well as monitoring medication side-effect profiles and potential drug-to-drug interactions as they pertain to each individual patient involved in the study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University Medical Faculty Associates
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- History of HF with reduced ejection fraction (HFrEF) or ejection fraction (EF) <50% and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) < 60cc/min/1.73m2
Exclusion Criteria:
- Patients < 18 years of age
- Patients with a heart or kidney transplant
- Patients on dialysis at the time of enrollment
- Pregnant
- Non-English speaking
- Patients that are unable to understand the process of the study and consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Patients randomized based on their primary care clinician to a co-localized care with a telemedicine-based cardiorenal multidisciplinary team (cardiologist, nephrologist, and research coordinators) providing guidance and recommendations to the primary care clinician.
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The intervention group will be patients whose primary care clinicians will be receiving guidance and recommendations from the multidisciplinary team consisting of cardiologists, nephrologists, and specialty pharmacists.
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No Intervention: Control
Patients randomized to the control group will proceed with usual care with a primary care clinician making referrals to a cardiologist or nephrologist "for-cause" as determined by the primary care clinician, to ultimately assess the rates of improvement in the implementation of GDMT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in rate of sodium glucose co-transporter 2 inhibitors (SGLT2i)
Time Frame: 6 months
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Given that increased SGLT2i is likely to be the major driver of improved clinical outcomes in patients with heart failure and chronic kidney disease, the primary outcome of interest is the difference in rate of SGLT2i use between multidisciplinary care model versus usual care model at 3 months and 6 months.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of life of patients-Kidney Disease Questionnaire
Time Frame: 6 months
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Quality of life will be measured by a score at baseline, 3-months, and 6-months, using the Kidney Disease and Quality of Life survey (KDQOL-36).
|
6 months
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Quality of life of patients-Cardiomyopathy Questionnaire
Time Frame: 6 months
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Quality of life will be measured by a score at baseline, 3-months, and 6-months, using the Cardiomyopathy Questionnaire (Kansas City) (KCCQ-12).
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6 months
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Heart failure hospitalizations
Time Frame: 6 months
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Heart failure hospitalizations, ≥40% sustained decline in kidney function, need for maintenance dialysis or a kidney transplant.
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Janai Rangaswami, MD, Fellowship program director for the Division of Nephrology, Director of the cardiorenal program
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Heart Failure
- Kidney Diseases
- Renal Insufficiency, Chronic
Other Study ID Numbers
- NCR224155
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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