Use of NT-proBNP Testing to Guide Heart Failure Therapy in the Outpatient Setting.
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 3/27/2019 |
| Start Date: | September 2005 |
| End Date: | June 2009 |
The Use of Pro-Brain Natriuretic Peptide Targeted Therapy to Tailor Medical Management of Patients With Congestive Heart Failure Followed in an Outpatient Setting: the ProBNP Outpatient Tailored CHF Therapy (PROTECT) Study
Levels of amino-terminal pro-brain natriuretic peptide (NT-proBNP) a hormone released from
the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such
as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta
blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in
parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels
may identify a patient at high risk for adverse outcome from their HF, even in periods of
apparent stability.
It remains unclear, however, whether treating patients based on their NT-proBNP
concentrations would be associated with better outcomes compared to standard HF therapy
without measurement of NT-proBNP values.
The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and
recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to
standard HF therapy without such 'hormone guided' treatment.
the heart in patients with heart failure (HF) are strongly prognostic of adverse events, such
as hospitalization or death from HF. Therapies that are beneficial for HF (such as beta
blockers or angiotensin converting enzyme inhibitors) tend to lower levels of NT-proBNP in
parallel with improvements in outcomes of patients so treated. Importantly, Nt-proBNP levels
may identify a patient at high risk for adverse outcome from their HF, even in periods of
apparent stability.
It remains unclear, however, whether treating patients based on their NT-proBNP
concentrations would be associated with better outcomes compared to standard HF therapy
without measurement of NT-proBNP values.
The goal of the PROTECT study is to evaluate whether treatment of patients with advanced and
recently destabilized HF would benefit from NT-proBNP guided HF treatment, compared to
standard HF therapy without such 'hormone guided' treatment.
300 patients with class II-IV heart failure (HF) due to systolic dysfunction (left
ventricular ejection fraction <40%) and recent (within 6 months) destabilized HF will be
randomized 1:1 to either 'standard of care' therapy for their HF versus 'standard of care
plus NT-proBNP guided' care.
At randomization, patients at MGH will undergo a 2-dimensional echocardiogram for cardiac
structure and function.
Patients randomized to the 'standard of care' arm of the study will receive aggressive
therapy for their HF, including evidence-based addition/titration of therapeutic agents in
the trial, such as carvedilol or metoprolol XL, angiotensin converting enzyme inhibitors or
angiotensin receptor blockers, spironolactone inhibitors (for those in class III or IV),
digoxin (when applicable), loop diuretics, as well as nitrates with or without hydralazine.
Biventricular pacing with/without ICD capability will be performed at the discretion of the
investigator. Any changes in therapy will be accompanied by a 2 week follow up for
re-assessment and further titration of medications, based on clinical judgment.
At each interim visit, patients in the 'standard of care' arm will have a Minnesota Living
with Heart Failure questionnaire taken. For all visits, including those triggered by med
changes, laboratories will be checked including serum chemistries; a sample of blood for
blinded NT-proBNP, troponin T, and high sensitivity CRP will be obtained for measurement
after the trial is complete.
Patients randomized to the 'standard of care plus NT-proBNP guided' arm will receive the same
aggressive medical care as above, but will also have an unblinded measurement of NT-proBNP
provided to the study investigator within an hour of first patient contact. Therapeutic
decision-making will be first based on clinical acumen/judgment, but if the NT-proBNP is
elevated, per protocol, the investigator will adjust therapies accordingly, including
escalation of existing therapies with known effects on NT-proBNP levels, as well as possible
addition of similar therapies not yet in use (such as spironolactone).
Patients will be followed for events including destabilized HF (in or outpatient),
cardiovascular events (including ischemic complications, ICD discharge, or development of
non-fatal arrhythmia such as atrial fibrillation), or death.
At the end of one year, event rates will be assessed and the outcomes in the two arms will be
compared. As well, echocardiography will be performed on subjects at one year and differences
from baseline in both groups will be assessed.
ventricular ejection fraction <40%) and recent (within 6 months) destabilized HF will be
randomized 1:1 to either 'standard of care' therapy for their HF versus 'standard of care
plus NT-proBNP guided' care.
At randomization, patients at MGH will undergo a 2-dimensional echocardiogram for cardiac
structure and function.
Patients randomized to the 'standard of care' arm of the study will receive aggressive
therapy for their HF, including evidence-based addition/titration of therapeutic agents in
the trial, such as carvedilol or metoprolol XL, angiotensin converting enzyme inhibitors or
angiotensin receptor blockers, spironolactone inhibitors (for those in class III or IV),
digoxin (when applicable), loop diuretics, as well as nitrates with or without hydralazine.
Biventricular pacing with/without ICD capability will be performed at the discretion of the
investigator. Any changes in therapy will be accompanied by a 2 week follow up for
re-assessment and further titration of medications, based on clinical judgment.
At each interim visit, patients in the 'standard of care' arm will have a Minnesota Living
with Heart Failure questionnaire taken. For all visits, including those triggered by med
changes, laboratories will be checked including serum chemistries; a sample of blood for
blinded NT-proBNP, troponin T, and high sensitivity CRP will be obtained for measurement
after the trial is complete.
Patients randomized to the 'standard of care plus NT-proBNP guided' arm will receive the same
aggressive medical care as above, but will also have an unblinded measurement of NT-proBNP
provided to the study investigator within an hour of first patient contact. Therapeutic
decision-making will be first based on clinical acumen/judgment, but if the NT-proBNP is
elevated, per protocol, the investigator will adjust therapies accordingly, including
escalation of existing therapies with known effects on NT-proBNP levels, as well as possible
addition of similar therapies not yet in use (such as spironolactone).
Patients will be followed for events including destabilized HF (in or outpatient),
cardiovascular events (including ischemic complications, ICD discharge, or development of
non-fatal arrhythmia such as atrial fibrillation), or death.
At the end of one year, event rates will be assessed and the outcomes in the two arms will be
compared. As well, echocardiography will be performed on subjects at one year and differences
from baseline in both groups will be assessed.
Inclusion Criteria:
- Age > 21 years of age
- Left ventricular ejection fraction ≤ 40%
- NYHA class II-IV heart failure
- Hospital admission, Emergency Department visit, or outpatient diuretic escalation of
therapy for destabilized HF at least once in the 6 months prior to enrollment
Exclusion Criteria:
- Severe renal insufficiency defined as serum creatinine > 2.5 mg/dl
- Inoperable aortic valvular heart disease
- Life expectancy <1 year due to causes other than HF such as advanced cancer
- Cardiac transplantation or revascularization indicated or expected within 6 months
- Severe obstructive or restrictive pulmonary disease, defined as a forced expiratory
volume in 1S <1 L when diagnosed as standard of care.
- Subject unable or unwilling to provide written informed consent
- Coronary revascularization (PCI or CABG) within the previous 3 months
We found this trial at
1
site
Click here to add this to my saved trials
