Congestive Heart FailurePROTECTNCT00351390
Use of NT-proBNP Testing to Guide Heart Failure Therapy in the Outpatient Setting.
A study testing Drug therapy for HF and NT-proBNP guided HF therapy in people with Congestive Heart Failure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Drug therapy for HF and NT-proBNP guided HF therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jun 2009
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02467
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Drug therapy for HF, NT-proBNP guided HF therapy
- Keywords
- congestive heart failure treatment, congestive heart failure, prognosis, NT-proBNP testing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug therapy for HFOther
Titration of HF meds in an aggressive out patient manner following guideline direction
NT-proBNP guided HF therapyOther
Standard of care drug therapy following guideline direction, plus adjustment of medication titrated to achieve NT-proBNP <1000 pg/mL
| Study group | Role | What they receive |
|---|---|---|
| SOC | Placebo comparator | Standard of care HF therapy without NT-proBNP guidance Receives: Other: Drug therapy for HF |
| NT-proBNP arm | Active comparator | NT-proBNP plus standard HF management Receives: Other: NT-proBNP guided HF therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events
Measured: One year
Secondary outcomes (7)
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of outpatient decompensated HF.
Measured: One year
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on change in NT-proBNP levels, both the change in absolute value as well as in relative value, from baseline to end of study.
Measured: One year
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy alone on echocardiographic parameters including LV systolic and diastolic function, RV systolic and diastolic function, RV systolic pressures, degree of valvular
Measured: One year
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of all cause mortality.
Measured: One year
Ability of cTnT and hsCRP, independently as well as together with NT-proBNP, to predict cardiovascular endpoints.
Measured: One year
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy alone on patient quality of life.
Measured: One year
Cost benefits of NT-proBNP guided HF therapy versus standard of care.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2006 (estimated)
- Study startSep 2005
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Congestive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, James L. Januzzi, Massachusetts General Hospital
- Investigators
- James L. Januzzi, MD, FACC, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351390
- Sponsor's protocol ID
- 2004-P-001447/12
- Acronym
- PROTECT
- Status last verified
- Mar 2019
- First submitted
- 10 Jul 2006
- Last updated
- 25 Mar 2019
- Results posted
- No
Publications
Shah R, Ziegler O, Yeri A, Liu X, Murthy V, Rabideau D, Xiao CY, Hanspers K, Belcher A, Tackett M, Rosenzweig A, Pico AR, Januzzi JL, Das S. MicroRNAs Associated With Reverse Left Ventricular Remodeling in Humans Identify Pathways of Heart Failure Progression. Circ Heart Fail. 2018 Feb;11(2):e004278. doi: 10.1161/CIRCHEARTFAILURE.117.004278.
PubMed 29438982Motiwala SR, Gaggin HK, Gandhi PU, Belcher A, Weiner RB, Baggish AL, Szymonifka J, Januzzi JL Jr. Concentrations of highly sensitive cardiac troponin-I predict poor cardiovascular outcomes and adverse remodeling in chronic heart failure. J Cardiovasc Transl Res. 2015 Apr;8(3):164-72. doi: 10.1007/s12265-015-9618-4. Epub 2015 Mar 17.
PubMed 25777344Gandhi PU, Motiwala SR, Belcher AM, Gaggin HK, Weiner RB, Baggish AL, Fiuzat M, Brunner-La Rocca HP, Januzzi JL Jr. Galectin-3 and mineralocorticoid receptor antagonist use in patients with chronic heart failure due to left ventricular systolic dysfunction. Am Heart J. 2015 Mar;169(3):404-411.e3. doi: 10.1016/j.ahj.2014.12.012. Epub 2015 Jan 7.
PubMed 25728731Gaggin HK, Szymonifka J, Bhardwaj A, Belcher A, De Berardinis B, Motiwala S, Wang TJ, Januzzi JL Jr. Head-to-head comparison of serial soluble ST2, growth differentiation factor-15, and highly-sensitive troponin T measurements in patients with chronic heart failure. JACC Heart Fail. 2014 Feb;2(1):65-72. doi: 10.1016/j.jchf.2013.10.005. Epub 2014 Jan 25.
PubMed 24622120Motiwala SR, Szymonifka J, Belcher A, Weiner RB, Baggish AL, Gaggin HK, Bhardwaj A, Januzzi JL Jr. Measurement of novel biomarkers to predict chronic heart failure outcomes and left ventricular remodeling. J Cardiovasc Transl Res. 2014 Mar;7(2):250-61. doi: 10.1007/s12265-013-9522-8. Epub 2013 Dec 6.
PubMed 24309956Gaggin HK, Motiwala S, Bhardwaj A, Parks KA, Januzzi JL Jr. Soluble concentrations of the interleukin receptor family member ST2 and beta-blocker therapy in chronic heart failure. Circ Heart Fail. 2013 Nov;6(6):1206-13. doi: 10.1161/CIRCHEARTFAILURE.113.000457. Epub 2013 Oct 10.
PubMed 24114865Bhardwaj A, Rehman SU, Mohammed AA, Gaggin HK, Barajas L, Barajas J, Moore SA, Sullivan D, Januzzi JL. Quality of life and chronic heart failure therapy guided by natriuretic peptides: results from the ProBNP Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) study. Am Heart J. 2012 Nov;164(5):793-799.e1. doi: 10.1016/j.ahj.2012.08.015.
PubMed 23137512Weiner RB, Baggish AL, Chen-Tournoux A, Marshall JE, Gaggin HK, Bhardwaj A, Mohammed AA, Rehman SU, Barajas L, Barajas J, Gregory SA, Moore SA, Semigran MJ, Januzzi JL Jr. Improvement in structural and functional echocardiographic parameters during chronic heart failure therapy guided by natriuretic peptides: mechanistic insights from the ProBNP Outpatient Tailored Chronic Heart Failure (PROTECT) study. Eur J Heart Fail. 2013 Mar;15(3):342-51. doi: 10.1093/eurjhf/hfs180. Epub 2012 Nov 6.
PubMed 23132825Gaggin HK, Mohammed AA, Bhardwaj A, Rehman SU, Gregory SA, Weiner RB, Baggish AL, Moore SA, Semigran MJ, Januzzi JL Jr. Heart failure outcomes and benefits of NT-proBNP-guided management in the elderly: results from the prospective, randomized ProBNP outpatient tailored chronic heart failure therapy (PROTECT) study. J Card Fail. 2012 Aug;18(8):626-34. doi: 10.1016/j.cardfail.2012.05.005. Epub 2012 Jun 19.
PubMed 22858078Januzzi JL Jr, Rehman SU, Mohammed AA, Bhardwaj A, Barajas L, Barajas J, Kim HN, Baggish AL, Weiner RB, Chen-Tournoux A, Marshall JE, Moore SA, Carlson WD, Lewis GD, Shin J, Sullivan D, Parks K, Wang TJ, Gregory SA, Uthamalingam S, Semigran MJ. Use of amino-terminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011 Oct 25;58(18):1881-9. doi: 10.1016/j.jacc.2011.03.072.
PubMed 22018299Bhardwaj A, Rehman SU, Mohammed A, Baggish AL, Moore SA, Januzzi JL Jr. Design and methods of the Pro-B Type Natriuretic Peptide Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study. Am Heart J. 2010 Apr;159(4):532-538.e1. doi: 10.1016/j.ahj.2010.01.005.
PubMed 20362709
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00351390
- Acronym / sponsor ID
- PROTECT / 2004-P-001447/12
- Conditions
- Congestive Heart Failure
- Keywords
- congestive heart failure treatment, congestive heart failure, prognosis, NT-proBNP testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- Sep 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 Jul 2006 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC | Placebo comparator | Other: Drug therapy for HFStandard of care HF therapy without NT-proBNP guidance |
| NT-proBNP arm | Active comparator | Other: NT-proBNP guided HF therapyNT-proBNP plus standard HF management |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug therapy for HFTitration of HF meds in an aggressive out patient manner following guideline direction | Other | SOC |
| NT-proBNP guided HF therapyStandard of care drug therapy following guideline direction, plus adjustment of medication titrated to achieve NT-proBNP <1000 pg/mL | Other | NT-proBNP arm |
Primary outcome
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events
Time frame: One year
7 secondary outcomes
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of outpatient decompensated HF.
Time frame: One year
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on change in NT-proBNP levels, both the change in absolute value as well as in relative value, from baseline to end of study.
Time frame: One year
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy alone on echocardiographic parameters including LV systolic and diastolic function, RV systolic and diastolic function, RV systolic pressures, degree of valvular
Time frame: One year
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of all cause mortality.
Time frame: One year
Ability of cTnT and hsCRP, independently as well as together with NT-proBNP, to predict cardiovascular endpoints.
Time frame: One year
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy alone on patient quality of life.
Time frame: One year
Cost benefits of NT-proBNP guided HF therapy versus standard of care.
Time frame: One year
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 Mar 2019.
- Derived from this study: PubMed 29438982Shah R, Ziegler O, Yeri A, Liu X, Murthy V, Rabideau D, Xiao CY, Hanspers K, Belcher A, Tackett M, Rosenzweig A, Pico AR, Januzzi JL, Das S. MicroRNAs Associated With Reverse Left Ventricular Remodeling in Humans Identify Pathways of Heart Failure Progression. Circ Heart Fail. 2018 Feb;11(2):e004278. doi: 10.1161/CIRCHEARTFAILURE.117.004278.
- Derived from this study: PubMed 25777344Motiwala SR, Gaggin HK, Gandhi PU, Belcher A, Weiner RB, Baggish AL, Szymonifka J, Januzzi JL Jr. Concentrations of highly sensitive cardiac troponin-I predict poor cardiovascular outcomes and adverse remodeling in chronic heart failure. J Cardiovasc Transl Res. 2015 Apr;8(3):164-72. doi: 10.1007/s12265-015-9618-4. Epub 2015 Mar 17.
- Derived from this study: PubMed 25728731Gandhi PU, Motiwala SR, Belcher AM, Gaggin HK, Weiner RB, Baggish AL, Fiuzat M, Brunner-La Rocca HP, Januzzi JL Jr. Galectin-3 and mineralocorticoid receptor antagonist use in patients with chronic heart failure due to left ventricular systolic dysfunction. Am Heart J. 2015 Mar;169(3):404-411.e3. doi: 10.1016/j.ahj.2014.12.012. Epub 2015 Jan 7.
- Derived from this study: PubMed 24622120Gaggin HK, Szymonifka J, Bhardwaj A, Belcher A, De Berardinis B, Motiwala S, Wang TJ, Januzzi JL Jr. Head-to-head comparison of serial soluble ST2, growth differentiation factor-15, and highly-sensitive troponin T measurements in patients with chronic heart failure. JACC Heart Fail. 2014 Feb;2(1):65-72. doi: 10.1016/j.jchf.2013.10.005. Epub 2014 Jan 25.
- Derived from this study: PubMed 24309956Motiwala SR, Szymonifka J, Belcher A, Weiner RB, Baggish AL, Gaggin HK, Bhardwaj A, Januzzi JL Jr. Measurement of novel biomarkers to predict chronic heart failure outcomes and left ventricular remodeling. J Cardiovasc Transl Res. 2014 Mar;7(2):250-61. doi: 10.1007/s12265-013-9522-8. Epub 2013 Dec 6.
- Derived from this study: PubMed 24114865Gaggin HK, Motiwala S, Bhardwaj A, Parks KA, Januzzi JL Jr. Soluble concentrations of the interleukin receptor family member ST2 and beta-blocker therapy in chronic heart failure. Circ Heart Fail. 2013 Nov;6(6):1206-13. doi: 10.1161/CIRCHEARTFAILURE.113.000457. Epub 2013 Oct 10.
- Derived from this study: PubMed 23137512Bhardwaj A, Rehman SU, Mohammed AA, Gaggin HK, Barajas L, Barajas J, Moore SA, Sullivan D, Januzzi JL. Quality of life and chronic heart failure therapy guided by natriuretic peptides: results from the ProBNP Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) study. Am Heart J. 2012 Nov;164(5):793-799.e1. doi: 10.1016/j.ahj.2012.08.015.
- Derived from this study: PubMed 23132825Weiner RB, Baggish AL, Chen-Tournoux A, Marshall JE, Gaggin HK, Bhardwaj A, Mohammed AA, Rehman SU, Barajas L, Barajas J, Gregory SA, Moore SA, Semigran MJ, Januzzi JL Jr. Improvement in structural and functional echocardiographic parameters during chronic heart failure therapy guided by natriuretic peptides: mechanistic insights from the ProBNP Outpatient Tailored Chronic Heart Failure (PROTECT) study. Eur J Heart Fail. 2013 Mar;15(3):342-51. doi: 10.1093/eurjhf/hfs180. Epub 2012 Nov 6.
- Derived from this study: PubMed 22858078Gaggin HK, Mohammed AA, Bhardwaj A, Rehman SU, Gregory SA, Weiner RB, Baggish AL, Moore SA, Semigran MJ, Januzzi JL Jr. Heart failure outcomes and benefits of NT-proBNP-guided management in the elderly: results from the prospective, randomized ProBNP outpatient tailored chronic heart failure therapy (PROTECT) study. J Card Fail. 2012 Aug;18(8):626-34. doi: 10.1016/j.cardfail.2012.05.005. Epub 2012 Jun 19.
- Derived from this study: PubMed 22018299Januzzi JL Jr, Rehman SU, Mohammed AA, Bhardwaj A, Barajas L, Barajas J, Kim HN, Baggish AL, Weiner RB, Chen-Tournoux A, Marshall JE, Moore SA, Carlson WD, Lewis GD, Shin J, Sullivan D, Parks K, Wang TJ, Gregory SA, Uthamalingam S, Semigran MJ. Use of amino-terminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011 Oct 25;58(18):1881-9. doi: 10.1016/j.jacc.2011.03.072.
- Derived from this study: PubMed 20362709Bhardwaj A, Rehman SU, Mohammed A, Baggish AL, Moore SA, Januzzi JL Jr. Design and methods of the Pro-B Type Natriuretic Peptide Outpatient Tailored Chronic Heart Failure Therapy (PROTECT) Study. Am Heart J. 2010 Apr;159(4):532-538.e1. doi: 10.1016/j.ahj.2010.01.005.
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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.
James L. Januzzi, MD, FACC principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug therapy for HF and NT-proBNP guided HF therapy in people with Congestive 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 4 inclusion and 7 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 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events (time frame: One year). 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 NCT00351390, which also lists 11 linked publications.
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 Mar 2019.