Recruiting

GDMT

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT05170165

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Using a clinical decision software to provide specific recommendation of a medication at a certain dosage

Study Details

Brief summary:

The purpose of this study is to test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) medication recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).

Conditions

Heart Failure

Study ID

NCT05170165

Start date

Jan 12, 2022

Status verified date

Aug, 2023

Completion date

Sep 25, 2023

Anticipated

Primary completion date

Sep 25, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Enrolled Subjects

Test a clinical decision support (CDS) tool that provides clinicians (cardiologists and nurse practitioners) recommendations regarding guideline directed medical therapy (GDMT) in patients with heart failure and reduced ejection fraction (HFrEF).

Interventions

Using a clinical decision software to provide specific recommendation of a medication at a certain dosage

During routine follow-up, clinicians, cardiologists, and NPs who have a scheduled visit with an enrolled patient will be offered a medication recommendation. The medication recommendation will be generated by the clinical decision support tool. The software will advise the cardiologist whether an HF medication should be initiated, discontinued, or the dosage titrated and if the patient requires labs. In addition, the software, or decision engine (DE), will be run once weekly and every time the patient has new basic metabolic panel results. If the patient is admitted to the hospital, skilled nursing facility, or inpatient rehabilitation unit, the use of DE will be placed on hold until the patient is discharged and at home.

Primary outcome measure

  • Proportion of patients at or above 50% target dose of GDMT in HFrEF patients [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Allison Peterson, PhD

424-314-0048allison.peterson@csmns.org

Maurice Herring

310-248-8375maurice.herring@cshs.org

Locations

Cedars Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Maurice Herring

310-248-8375maurice.herring@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Sep 5, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2023-09-05.