Guideline Directed Medical Therapy in Patients With Heart Failure

NCT06700213 | Completed

• 1 other identifier: 2023P001526
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

heart failure; quality improvement; angiotensin converting enzyme inhibitors; angiotensin receptor/neprilysin inhibitors; angiotensin II receptor blockers; evidence based beta blockers

Outcome Measures

Primary Outcomes (1)

• GDMT Administration for HF

  Effect of GDMT Clinic versus Usual Care on administration of GDMT for HF.

  12 weeks

Secondary Outcomes (1)

• Mechanistic HF Outcomes

  12 weeks

Other Outcomes (2)

• Tolerability of GDMT Initiation

  12 weeks

• Outcomes at 6 Months

  6 months

Study Arms (2)

Heart Failure

Cohort will be comprised of a minimum of 75 participatns with HFrEF and a minimum of 25 participants with HFmrEF/HFpEF. At each visit, presence of intolerances to GDMT will be sought and recorded. Medications will include those outlined by GDMT, including angiotensin receptor/neprilysin inhibitors (ARNI), angiotensin II receptor blockers (ARB), angiotensin converting enzyme inhibitors (ACEi), evidence based beta blockers (eBBB), aldosterone receptor antagonists (MRA), and sodium-glucose co-transporter 2 (SGLT2) inhibitors.

Research Patient Data Repository (RPDR)

Patients will be selected from those with available data following May of 2020 (after regulatory approval of SGLT2 inhibitors for treatment of HFrEF) or in the case of HFpEF following February 2022.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• AstraZeneca: collaborator
• Novartis: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 39387769 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood sample for circulating biomarkers is obtained at baseline and as part of routine follow up.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: September 22, 2023
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)