Heart FailureNCT07217106
A Study of Accelerated Guideline-Directed Medical Therapy for Heart Failure
An observational study of Heart Failure, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The aim of the study was to evaluate the efficacy and safety of a Guideline-Directed Medical Therapy (GDMT) clinic within a general cardiology practice relative to usual care. This study analyzed data from patients with heart failure (HF) who were referred to the GDMT clinic at Massachusetts General Hospital (MGH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2024to 1 Jul 2024
- 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: This was a retrospective, non-interventional cohort study.
Who may be able to join
- Diagnosis of HF, including new onset disease
- Established cardiovascular follow up at the hospital
- Received sub-optimal medical care defined as <50% target doses of GDMT agents
- Left ventricular ejection fraction (LVEF) <50%
Who cannot join
- Planned referral to the Advanced HF program
- Decompensated HF
- End-stage kidney disease
- o glomerular filtration rate (GFR) <15 mL/min/1.73m^2 or on renal replacement therapy
- Untreated severe valvular heart disease
- Advanced HF
Show all 14Show fewer
- Inotropic support
- Transplant or mechanical circulatory support (MCS) planned
- Enrolled in hospice or palliative care
- Life expectancy <12 months due to non-cardiovascular (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.
About this study
Official title: A Retrospective Assessment of Accelerated Guideline-Directed Medical Therapy for Heart Failure
The aim of the study was to evaluate the efficacy and safety of a Guideline-Directed Medical Therapy (GDMT) clinic within a general cardiology practice relative to usual care. This study analyzed data from patients with heart failure (HF) who were referred to the GDMT clinic at Massachusetts General Hospital (MGH). For the comparator arm, patients in the GDMT clinic were matched to data of patients contained within in the MGH Research Patient Data Repository (RPDR).
- Conditions
- Heart Failure
- Keywords
- Medical therapy, Implementation, Cardiac remodeling
- 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 |
|---|---|---|
| GDMT Clinic | Patients with HF with an abnormal ejection fraction (EF) who were referred to the GDMT clinic and underwent rapid guideline-recommended medication titration. | |
| Usual Care (RPRD) | Patients from the MGH RPRD receiving care since the 2022 United States HF guideline update who were matched in a 2:1 fashion to GDMT clinic patients. Matching was based on age, sex, race, duration of HF, ischemic heart disease, diabetes mellitus, atrial fibrillation and baseline EF. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Receiving all Four Class I GDMT Drugs at Final Visit of Follow-up
Class I GDMT drugs included angiotensin receptor/neprilysin inhibitor (ARNI), evidence-based beta blocker (eBBB), mineralocorticoid receptor antagonist (MRA), sodium-glucose co-transporter-2 inhibitor (SGLT2i) or renin angiotensin system inhibitor (RASi), eBBB, MRA, SGLT2i.
Measured: Up to approximately 16 weeks
Secondary outcomes (9)
Number Patients Receiving 50% or More of the Target Dose of Four Class I GDMT Drugs at Final Visit of Follow-up
Measured: Up to approximately 16 weeks
Number of Patients on a Higher Number of Therapies at Final Visit of Follow-up Compared to Baseline
Measured: Baseline and up to approximately 16 weeks
Change From Baseline in New York Heart Association (NYHA) Classification
The NYHA classification provides a simple way of classifying the extent of heart failure. It places patients in one of four categories based on how much they are limited during physical activity:
Class I - No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF.
Class II - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF.
Class III - Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF.
Class IV - Unable to carry out any physical activity without symptoms of HF, or symptoms of HF at rest.
Measured: Baseline and up to approximately 16 weeks
Change From Baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) Concentration
Measured: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: LVEF
Measured: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular End-Diastolic Volume Index (LVEDVi)
Measured: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular End-Systolic Volume Index (LVESVi)
Measured: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Atrial Volume Index (LAVi)
Measured: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular Mass Index (LVMi)
Measured: Baseline and up to approximately 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start3 Mar 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Retrospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217106
- Sponsor's protocol ID
- CLCZ696BUS36
- Status last verified
- Oct 2025
- First submitted
- 13 Oct 2025
- Last updated
- 15 Oct 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Assessment of Accelerated Guideline-Directed Medical Therapy for Heart Failure
- ClinicalTrials.gov ID
- NCT07217106
- Acronym / sponsor ID
- CLCZ696BUS36
- Conditions
- Heart Failure
- Keywords
- Medical therapy, Implementation, Cardiac remodeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Oct 2025 (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 aim of the study was to evaluate the efficacy and safety of a Guideline-Directed Medical Therapy (GDMT) clinic within a general cardiology practice relative to usual care. This study analyzed data from patients with heart failure (HF) who were referred to the GDMT clinic at Massachusetts General Hospital (MGH). For the comparator arm, patients in the GDMT clinic were matched to data of patients contained within in the MGH Research Patient Data Repository (RPDR).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDMT Clinic | – | –Patients with HF with an abnormal ejection fraction (EF) who were referred to the GDMT clinic and underwent rapid guideline-recommended medication titration. |
| Usual Care (RPRD) | – | –Patients from the MGH RPRD receiving care since the 2022 United States HF guideline update who were matched in a 2:1 fashion to GDMT clinic patients. Matching was based on age, sex, race, duration of HF, ischemic heart disease, diabetes mellitus, atrial fibrillation and baseline EF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, non-interventional cohort study.
Key inclusion criteria (4 listed)
- Diagnosis of HF, including new onset disease
- Established cardiovascular follow up at the hospital
- Received sub-optimal medical care defined as <50% target doses of GDMT agents
- Left ventricular ejection fraction (LVEF) <50%
Key exclusion criteria (14 listed)
- Planned referral to the Advanced HF program
- Decompensated HF
- End-stage kidney disease
- o glomerular filtration rate (GFR) <15 mL/min/1.73m^2 or on renal replacement therapy
- Untreated severe valvular heart disease
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
Number of Patients Receiving all Four Class I GDMT Drugs at Final Visit of Follow-up
Time frame: Up to approximately 16 weeks
Class I GDMT drugs included angiotensin receptor/neprilysin inhibitor (ARNI), evidence-based beta blocker (eBBB), mineralocorticoid receptor antagonist (MRA), sodium-glucose co-transporter-2 inhibitor (SGLT2i) or renin angiotensin system inhibitor (RASi), eBBB, MRA, SGLT2i.
9 secondary outcomes
Number Patients Receiving 50% or More of the Target Dose of Four Class I GDMT Drugs at Final Visit of Follow-up
Time frame: Up to approximately 16 weeks
Number of Patients on a Higher Number of Therapies at Final Visit of Follow-up Compared to Baseline
Time frame: Baseline and up to approximately 16 weeks
Change From Baseline in New York Heart Association (NYHA) Classification
Time frame: Baseline and up to approximately 16 weeks
Change From Baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) Concentration
Time frame: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: LVEF
Time frame: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular End-Diastolic Volume Index (LVEDVi)
Time frame: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular End-Systolic Volume Index (LVESVi)
Time frame: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Atrial Volume Index (LAVi)
Time frame: Baseline and up to approximately 16 weeks
Change From Baseline in Echocardiography Measurement: Left Ventricular Mass Index (LVMi)
Time frame: Baseline and up to approximately 16 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 15 Oct 2025.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Novartis Pharmaceuticals 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 4 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 15 Oct 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?
Number of Patients Receiving all Four Class I GDMT Drugs at Final Visit of Follow-up (time frame: Up to approximately 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2025.