RECRUITING

Early Assessment and Initiation of GuideLine-Directed Evidence-Based Management-HF

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

EAGLE-HF (Early Assessment and initiation of GuideLine-directed Evidence-based management-HF) is a prospective single site study of a multinational, unblinded, randomized-controlled, longitudinal trial called SYMPHONY. Primary, secondary and exploratory outcomes that are part of SYMPHONY are not described herein as they replicate SYMPHONY outcomes. Data associated with SYMPHONY outcomes will be sent to the SYMPHONY coordinating center. In EAGLE-HF, site investigators will examine if a new-onset heart failure (HF) diagnosis are asscoiated with social determinants of health (6 factors), social vulnerability index and distressed community indices. In addition, for patients diagnosed with HFrEF, prescribing patterns (use of and dose of) core HF medications will be assessed for association with physician practice type and medical provider type. Finally, (among participants in the SYMPHONY Active arm, an optimal NTproBNP cut-point will be assessed for diagnosis of HF based on social determinants of health, social vulnerability index, distressed community index, HF risk factors and medical comorbidities.

Official Title

EAGLE-HF is Part of a Multinational Group of Studies Titled; Screening for Early Heart Failure Diagnosis and Management in Primary Care or at Home Using Natriuretic Peptides and Echocardiography

Quick Facts

Study Start:2025-03-11
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06849752

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:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Inability to give informed consent; e.g., due to significant cognitive impairment, low English proficiency, inability to read, and/or inability to understand consent content or explanations provided by investigators
  2. * Previous diagnosis of HF (with any ejection fraction and due to any cause)
  3. * Receiving renal replacement therapy
  4. * Inability to travel to Cleveland Clinic for biomarker or handheld point-of-care echo with AI (receiving hospice or skilled nursing facility care).
  5. * Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g. a diagnosis which may compromise survival over the study period; female with a history of left breast mastectomy and breast reconstruction (inability to use AI echocardiogram) or history of only 1 visit to Cleveland Clinic for medical care in any service or with any provider (reflects a lack of using Cleveland Clinic for routine medical care)

Contacts and Locations

Study Contact

Nancy M Albert, PhD
CONTACT
2163129191
albertn@ccf.org
Michelle Levay, MSN
CONTACT
1-216-445-4749
levaym@ccf.org

Principal Investigator

Nancy Albert, PhD
PRINCIPAL_INVESTIGATOR
The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

  • Nancy Albert, PhD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

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 Date2025-03-11
Study Completion Date2031-12

Study Record Updates

Study Start Date2025-03-11
Study Completion Date2031-12

Terms related to this study

Keywords Provided by Researchers

  • medication prescribing
  • NTproBNP
  • Provider type
  • Social determinants of health

Additional Relevant MeSH Terms

  • Heart Failure
  • Socioeconomic Adversity