COMPLETED

COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in 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

This is a randomized, open-label, initiative within the Mass General Brigham healthcare system testing two remote care strategies for optimizing the prescription of guideline-directed medical therapies in patients with heart failure, regardless of left ventricular ejection fraction (LVEF).

Official Title

COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure

Quick Facts

Study Start:2023-05-05

Study Completion:2025-06-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05734690

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 to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Documented diagnosis of heart failure (e.g., ICD-9 codes 428 ICD-10 codes I50 or Problem list in the electronic health record) * Most recent EF assessed within the past 24 months * Seen Mass General Brigham provider within the last 24 months * English or Spanish speaking	* LVEF\<50% currently prescribed or intolerant to both ARNi and SGLT2i * LVEF\>50% currently prescribed or intolerant to SGLT2i * Systolic blood pressure (SBP) \<90 mmHg at last measure * Current severe aortic stenosis or severe aortic insufficiency * Known amyloid heart disease * Group 1 pulmonary arterial hypertension on disease-specific therapies (e.g., Ambrisentan, Bosentan, Epoprostenol, Treprostinil, Iloprost) * eGFR\<30 mL/min/1.73m2 * Active chemotherapy * Receiving end-of-life care or hospice * History of transplant, currently listed above status 4 or being evaluated for transplant * Outpatient intravenous inotrope use * Current use of a Ventricular Assist Device * Physician's discretion as inappropriate for remote management program

Inclusion Criteria

Exclusion Criteria

* Documented diagnosis of heart failure (e.g., ICD-9 codes 428 ICD-10 codes I50 or Problem list in the electronic health record)
* Most recent EF assessed within the past 24 months
* Seen Mass General Brigham provider within the last 24 months
* English or Spanish speaking

* LVEF\<50% currently prescribed or intolerant to both ARNi and SGLT2i
* LVEF\>50% currently prescribed or intolerant to SGLT2i
* Systolic blood pressure (SBP) \<90 mmHg at last measure
* Current severe aortic stenosis or severe aortic insufficiency
* Known amyloid heart disease
* Group 1 pulmonary arterial hypertension on disease-specific therapies (e.g., Ambrisentan, Bosentan, Epoprostenol, Treprostinil, Iloprost)
* eGFR\<30 mL/min/1.73m2
* Active chemotherapy
* Receiving end-of-life care or hospice
* History of transplant, currently listed above status 4 or being evaluated for transplant
* Outpatient intravenous inotrope use
* Current use of a Ventricular Assist Device
* Physician's discretion as inappropriate for remote management program

Contacts and Locations

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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 Date2023-05-05

Study Completion Date2025-06-09

Study Record Updates

Study Start Date2023-05-05

Study Completion Date2025-06-09

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure