Heart FailureTEAM-MGHNCT06700213
Guideline Directed Medical Therapy in Patients With Heart Failure
An observational study of Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to 22 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Keywords
- heart failure, quality improvement, angiotensin converting enzyme inhibitors, angiotensin receptor/neprilysin inhibitors, angiotensin II receptor blockers, evidence based beta blockers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GDMT Administration for HF
Effect of GDMT Clinic versus Usual Care on administration of GDMT for HF.
Measured: 12 weeks
Secondary outcomes (1)
Mechanistic HF Outcomes
Effect of GDMT Clinic versus Usual Care on changes in mechanistic HF outcomes.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start22 Sep 2023
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Novartis
- Responsible party
- Principal investigator, James L. Januzzi, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700213
- Sponsor's protocol ID
- 2023P001526
- Acronym
- TEAM-MGH
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39387769
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline Directed Medical Therapy in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT06700213
- Acronym / sponsor ID
- TEAM-MGH / 2023P001526
- Conditions
- Heart Failure
- Keywords
- heart failure, quality improvement, angiotensin converting enzyme inhibitors, angiotensin receptor/neprilysin inhibitors, angiotensin II receptor blockers, evidence based beta blockers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca, Novartis
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (14 listed)
- Planned referral to the Advanced HF program
- Decompensated HF
- End-stage kidney disease
- Untreated severe valvular heart disease
- Advanced HF
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GDMT Administration for HF
Time frame: 12 weeks
Effect of GDMT Clinic versus Usual Care on administration of GDMT for HF.
1 secondary outcome
Mechanistic HF Outcomes
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Results publication: PubMed 39387769Spahillari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GDMT Administration for HF (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06700213, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.