Optimizing heart failure treatment through remote care strategies
COPILOT-HF: Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure
PHASE4 · Brigham and Women's Hospital · NCT05734690
This study is testing two different remote care methods to see which one helps people with heart failure get the right medications better and if the order of starting those medications makes a difference.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05734690 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates two remote care strategies aimed at enhancing the prescription of guideline-directed medical therapies for patients with heart failure, regardless of their left ventricular ejection fraction. The study compares a virtual clinic that employs a standardized approach to medication optimization against a strategy that focuses on patient and provider education followed by remote management. Additionally, it investigates whether the order of initiating medications affects treatment intensification in patients with reduced ejection fraction. The trial is conducted within the Mass General Brigham healthcare system.
Who should consider this trial
Good fit: Ideal candidates include patients with a documented diagnosis of heart failure who have been seen by a Mass General Brigham provider within the last 24 months and can communicate in English or Spanish.
Not a fit: Patients with certain severe conditions, such as those currently prescribed or intolerant to specific heart failure medications, or those with eGFR below 30 mL/min/1.73m2, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for patients with heart failure through optimized medication therapy.
How similar studies have performed: Other studies have shown promise in optimizing heart failure treatment through remote care strategies, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Daniel Gabovitch, MGB
- Email: dgabovitch@bwh.harvard.edu
- Phone: 6177633692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure