RECRUITING

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

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Conditions

Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Pilot Study to Increase Utilization of Guideline Directed Medical Therapy in Patients With HFrEF

Quick Facts

Study Start:2022-01-12
Study Completion:2023-09-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05170165

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of HFrEF (left ejection fraction \< 40%, assessed by transthoracic echo, cardiac MRI, cardiac SPECT) within the past year.
  2. * New York Heart Association (NYHA) class II-III at most recent screening assessment.
  3. * GDMT composite score of less than or equal to 50% at baseline
  1. * Previous contraindication to beta blockers, ACE inhibitors, and/or ARB.
  2. * Baseline creatinine \> 2 mg/dl or potassium level at baseline \> 5 mEq/L or eGFR \<30 mL/min/1.73 m2.
  3. * Baseline systolic blood pressure \< 100 mmHg.
  4. * Concomitant use of ACE, ARB, and/or ARNI
  5. * Polycystic kidney disease
  6. * History of angioedema
  7. * History of or currently on a transplant list
  8. * Left ventricular assist device
  9. * Uncontrolled asthma
  10. * Severe COPD
  11. * Cirrhosis
  12. * Currently receiving hospice or comfort care
  13. * Patient not proficient with written and spoken English
  14. * Patient has diminished decision making capability
  15. * History of non-compliance

Contacts and Locations

Study Contact

Allison Peterson, PhD
CONTACT
424-314-0048
allison.peterson@csmns.org
Maurice Herring
CONTACT
310-248-8375
maurice.herring@cshs.org

Principal Investigator

Raj Khandwalla, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars Sinai Medical Center
Los Angeles, California, 90048
United States

Collaborators and Investigators

Sponsor: Cedars-Sinai Medical Center

  • Raj Khandwalla, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-12
Study Completion Date2023-09-25

Study Record Updates

Study Start Date2022-01-12
Study Completion Date2023-09-25

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure