Clinical trial NCT06700213: Guideline Directed Medical Therapy in Patients with Heart Failure
Official title: Guideline Directed Medical Therapy in Patients with Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: heart failure
quality improvement
angiotensin converting enzyme inhibitors
angiotensin receptor/neprilysin inhibitors
angiotensin II receptor blockers
evidence based beta blockers
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Novartis
First posted: 2024-11-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ambulatory patients with NYHA Class I-IV HF, aged ≥18 years, directly referred to GDMT Clinic from cardiology clinics at MGH. A minimum of 75 patients with HFrEF will be included in the GDMT Clinic arm. Patients with improved EF will be included as HFrEF.

Brief summary: The TEAM-MGH study will formerly evaluate impact of the GDMT Clinic versus matched usual care patients on the proportion of GDMT administration over a 12 week period in approximately 300 total patients with HF across the spectrum of LVEF (with a minimum of 150 with HFrEF). The study will also assess impact of the GDMT Clinic on health status, functional capacity, biomarker profiles, cardiac remodeling and cardiovascular events.

Detailed description: The lack of adherence to Goal-Directed Medical Therapy (GDMT) is a major problem in modern HF care. Despite advances in therapies for those with HF along with well-articulated goals for achieving guideline-directed medical therapy (GDMT) for affected individuals, the treatment of persons with HF lags behind current recommended guideline approaches, with 30% of ambulatory patients with HFrEF not being prescribed angiotensin receptor/neprilysin inhibitors (ARNI), angiotensin converting enzyme inhibitors (ACEi), angiotensin II receptor blockers (ARB), or evidence based beta blockers (eBBB) and the majority not receiving target doses of these medications despite lack of medical contraindications. The reasons for gaps in care include hesitancy to change medical programs in ostensibly stable patients, concerns about risk of drug intolerances, worries about drug costs, as well as uncertainty about benefits. Additionally, complexity of medical therapy, rapid evolution in the currently recommended therapeutic options, and challenges in care coordination also result in missed treatment opportunities. Given that most individuals with HF are cared for by specialists other than those trained in advanced HF therapies, this intersection of increasing complexity of care results in substantial gaps in care. The proposed research is to study impact of the GDMT clinic for patients across the spectrum of HF.

Eligibility 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

Primary outcomes:
measure: GDMT Administration for HF
timeFrame: 12 weeks
Secondary outcomes:
measure: Mechanistic HF Outcomes
timeFrame: 12 weeks
Other outcomes:
measure: Tolerability of GDMT Initiation
timeFrame: 12 weeks
measure: Outcomes at 6 Months
timeFrame: 6 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: Spahillari A, Cohen LP, Lin C, Liu Y, Tringale A, Sheppard KE, Ko C, Khairnar R, Williamson KM, Wasfy JH, Scott NS, Paquette C, Greene SJ, Fonarow GC, Januzzi JL Jr. Efficacy, Safety and Mechanistic Impact of a Heart Failure Guideline-Directed Medical Therapy Clinic. JACC Heart Fail. 2025 Apr;13(4):554-568. doi: 10.1016/j.jchf.2024.08.017. Epub 2024 Oct 9.