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Search / Trial NCT05170165

A Pilot Study to Increase Utilization of GDMT in Patients With HFrEF

Launched by CEDARS-SINAI MEDICAL CENTER · Dec 22, 2021

Trial Information

Current as of April 30, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking for ways to help doctors give better medication recommendations to patients with heart failure and reduced heart function, a condition known as HFrEF. The study will test a special tool that assists healthcare providers, like cardiologists and nurse practitioners, in choosing the right medications based on established guidelines. By improving how medications are prescribed, the goal is to enhance the health and well-being of patients suffering from this serious condition.

To participate in this trial, patients need to be between 65 and 74 years old and must have been diagnosed with HFrEF within the last year, showing moderate symptoms of heart failure. They should also have a score indicating they are not receiving adequate guideline-directed medical therapy. However, certain health conditions or previous experiences, like severe kidney issues or being on a transplant list, may prevent someone from joining. If you or a loved one qualifies and decides to take part, you can expect close monitoring and support from the research team as they work to find better treatments for heart failure.

Gender

ALL

Eligibility 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

About Cedars Sinai Medical Center

Cedars-Sinai Medical Center is a renowned nonprofit academic medical center located in Los Angeles, California, recognized for its commitment to patient care, research, and education. As a leading institution in clinical trials, Cedars-Sinai harnesses innovative approaches to advance medical knowledge and improve treatment outcomes across various specialties. With a multidisciplinary team of experts, state-of-the-art facilities, and a patient-centered approach, Cedars-Sinai actively contributes to the development of novel therapies and interventions, ensuring the highest standards of clinical research while prioritizing patient safety and ethical considerations.

Locations

Los Angeles, California, United States

Patients applied

0 patients applied

Trial Officials

Raj Khandwalla, MD

Principal Investigator

Cedars-Sinai Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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