Evaluating the impact of guideline-directed medical therapy in heart failure patients
Guideline Directed Medical Therapy in Patients with Heart Failure
This study is testing if a special clinic for heart failure can help patients get better treatment compared to regular care over 12 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06700213 on ClinicalTrials.gov |
What this trial studies
The TEAM-MGH study aims to assess the effectiveness of a specialized GDMT Clinic compared to standard care in improving the administration of guideline-directed medical therapy for heart failure patients over a 12-week period. Approximately 300 patients will be involved, with a focus on those with heart failure with reduced ejection fraction (HFrEF). The study will evaluate various outcomes, including health status, functional capacity, biomarker profiles, cardiac remodeling, and cardiovascular events, addressing the significant gaps in care for heart failure management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with heart failure who are receiving sub-optimal medical care.
Not a fit: Patients with advanced heart failure, those on inotropic support, or those with planned referrals to advanced heart failure programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the quality of heart failure treatment, leading to better patient outcomes and adherence to recommended therapies.
How similar studies have performed: Other studies have shown success in improving heart failure management through specialized clinics, indicating that this approach has potential based on previous findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of HF, including new onset disease * Established cardiovascular follow up at MGH * Receiving sub-optimal medical care defined as \<50% target doses of GDMT agents * Age ≥18 years * For HFpEF: * Presence of structural heart disease (LAVi \>34 mL/Kg2, E/e' \>14, or LVH) * Recent HF hospitalization or historical NT-proBNP \>300 pg/mL Exclusion Criteria: * Planned referral to the Advanced HF program * Decompensated HF * End-stage kidney disease * eGFR \<15 mL/min/1.73m2 or on renal replacement therapy * Untreated severe valvular heart disease * Advanced HF * Inotropic support * Transplant or MCS planned * Enrolled in hospice or palliative care * Life expectancy \<12 months due to non-CV disease * Pericardial constriction * Hypertrophic cardiomyopathy * Unwillingness or inability to take GDMT * Pregnancy or breast feeding
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: James Januzzi, MD
- Email: jjanuzzi@mgb.org
- Phone: 617-726-3443
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.