Improving heart failure treatment with a decision support tool
A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF
This study is testing a new tool that helps doctors and nurses give better heart failure treatment recommendations to patients at home.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05170165 on ClinicalTrials.gov |
What this trial studies
This study tests a clinical decision support (CDS) tool designed to enhance the utilization of guideline-directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF). By employing home blood pressure monitoring (HBPM) alongside electronic medical record (EMR) data, the CDS provides tailored medication recommendations to cardiologists and nurse practitioners. The goal is to safely initiate and adjust GDMT for patients outside of traditional clinical settings, thereby optimizing their treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with HFrEF and classified as NYHA class II-III who have a GDMT composite score of 50% or less.
Not a fit: Patients with contraindications to key heart failure medications or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management and outcomes for patients with heart failure.
How similar studies have performed: Other studies have shown promise in using clinical decision support tools to enhance treatment adherence and outcomes in heart failure patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of HFrEF (left ejection fraction \< 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year. * New York Heart Association (NYHA) class II-III at most recent screening assessment. * GDMT composite score of less than or equal to 50% at baseline Exclusion Criteria: * Previous contraindication to beta blockers, ACE inhibitors, and/or ARB. * Baseline creatinine \> 2 mg/dl or potassium level at baseline \> 5 mEq/L or eGFR \<30 mL/min/1.73 m2. * Baseline systolic blood pressure \< 100 mmHg. * Concomitant use of ACE, ARB, and/or ARNI * Polycystic kidney disease * History of angioedema * History of or currently on a transplant list * Left ventricular assist device * Uncontrolled asthma * Severe COPD * Cirrhosis * Currently receiving hospice or comfort care * Patient not proficient with written and spoken English * Patient has diminished decision making capability * History of non-compliance
Where this trial is running
Los Angeles, California
- Cedars Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Raj Khandwalla, MD — Cedars-Sinai Medical Center
- Study coordinator: Allison Peterson, PhD
- Email: allison.peterson@csmns.org
- Phone: 424-314-0048
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.