NCT06273085

Brief Summary

The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 15, 2024

Last Update Submit

February 22, 2024

Conditions

Heart FailurePatient Acceptance of Health Care

Keywords

heart failure with reduced ejection fractionpatient education

Outcome Measures

Primary Outcomes (1)

  • Change in GDMT score

    Changes in GDMT score defined by the Heart Failure Collaboratory (Vericiguat and Ivabradine score will not be included in this study)

    6 months

Secondary Outcomes (3)

  • Heart Failure hospitalization

    6 months

  • cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant

    6 months

  • Number of GDMT classes of medications in use

    6 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Intervention arm will receive initial face to face education during hospital admission and also an educational flier about GDMT. They will get 3 more sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers.

Behavioral: Patient education

Control

NO INTERVENTION

Control arm will receive initial face to face education during hospital admission and also an educational flier about GDMT.

Interventions

Patient educationBEHAVIORAL

3 sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Heart Failure reduced Ejection Fraction (EF≤40%)
  • Age \>18 years
  • Able to consent for enrollment.
  • Hospitalized at one of the Medstar facilities (Inpatient)

You may not qualify if:

  • Pregnancy
  • Patient with stage D heart failure candidates for advanced therapies or on home inotropes or receiving hospice service
  • Patients with advanced organ failure (End stage cancer, Advanced dementia, MELD (Model for End-Stage Liver Disease) score \> 30, GFR (Glomerular filtration rate) \<25) in whom GDMT is Futile
  • Patients with Heart failure Collaboratory Score (HFCS) of 9

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

RECRUITING

Medstar Harbor Hospital

Baltimore, Maryland, 21225, United States

RECRUITING

Medstar Franklin Medical Center

Baltimore, Maryland, 21237, United States

RECRUITING

Medstar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

RECRUITING

MeSH Terms

Conditions

Heart FailurePatient Acceptance of Health Care

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Anup Agarwal, MD

    MedStar Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anup Agarwal, MD

CONTACT

5066207815anup.agarwal@medstar.net

Sumanth Bandaru, MBBS

CONTACT

6462405289sumanthkumar.bandaru@medstar.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start

February 1, 2024

Primary Completion

February 1, 2025

Study Completion

February 1, 2025

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

US(4)