Creating A Cardiorenal Multidisciplinary Team for Management HF and CKD Patients

NCT05531214 | Completed DMC

• 1 other identifier: NCR224155
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

Several drugs have been labeled as guideline-directed-medical therapies (GDMT) to improve overall health outcomes and slow the progression of disease in patients with heart failure (HF). Although scientific trials have deemed these drugs to be successful, many HF patients have been unable to either get started on the appropriate drug regimens or be optimized on the doses required to show substantial benefit, particularly in those who also suffer from chronic kidney disease (CKD). This is largely due to the current health care delivery model that requires a primary care clinician or general internist to refer patients to heart failure specialists and nephrologists. The specialty care itself then requires even more coordination resulting in patients getting lost to follow-up, physicians losing track of recommendations from different clinics, and too many separate electronic medical documentations to consolidate prior to deciding on what medication is appropriate at one thirty-minute outpatient visit. This study plans to create a new, virtual cardio-renal multidisciplinary team including a heart failure specialist and nephrologist to ease the coordination of care and consequently show a better implementation of GDMT in patients with HF and CKD when comparing those rates to the traditional referral-based way that these medications get prescribed.

Conditions

Heart Failure; Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

• Difference in rate of sodium glucose co-transporter 2 inhibitors (SGLT2i)

  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.

  6 months

Secondary Outcomes (3)

• Quality of life of patients-Kidney Disease Questionnaire

  6 months

• Quality of life of patients-Cardiomyopathy Questionnaire

  6 months

• Heart failure hospitalizations

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Multidisciplinary Care Coordination Team

Control

NO INTERVENTION

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.

Interventions

Multidisciplinary Care Coordination Team BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janai Rangaswami, MD

  Fellowship program director for the Division of Nephrology, Director of the cardiorenal program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: These primary care clinicians will then be block randomized using a 1:1 ratio to either arm of treatment utilizing random number generation. Primary care clinicians will be stratified by the size of their individual practices, and patients will be stratified by EF prior to their enrollment to balance the representation of patients with HFrEF (EF \< 50%) and heart failure with mildly reduced ejection fraction (HFmrEF) (EF 41-49%), respectively.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Fellowship Director of Nephrology, Cardiorenal Program Director

Model Details: Our pragmatic randomized controlled trial will firstly identify primary care clinicians (PCCs) currently working at the George Washington University Medical Faculty Associates (GW-MFA) who care for adult patients diagnosed with both heart failure with a reduced ejection fraction (HFrEF) and chronic kidney disease (CKD). 164 patients who meet our inclusion criteria will be first identified via their respective PCCs at the GW-MFA. These PCCs will be randomized to the control and intervention arms, and the intervention arm will be receiving recommendations from a multidisciplinary team of cardiologists and nephrologists.

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: September 7, 2022
• Study Start: June 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: June 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)