NCT00351390

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

3.8 years

First QC Date

July 10, 2006

Last Update Submit

March 21, 2019

Conditions

Congestive Heart Failure

Keywords

congestive heart failure treatmentcongestive heart failure, prognosisNT-proBNP testing

Outcome Measures

Primary Outcomes (1)

  • Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events

    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.

    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.

    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

    One year

  • Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of all cause mortality.

    One year

  • Ability of cTnT and hsCRP, independently as well as together with NT-proBNP, to predict cardiovascular endpoints.

    One year

  • +2 more secondary outcomes

Study Arms (2)

SOC

PLACEBO COMPARATOR

Standard of care HF therapy without NT-proBNP guidance

Other: Drug therapy for HF

NT-proBNP arm

ACTIVE COMPARATOR

NT-proBNP plus standard HF management

Other: NT-proBNP guided HF therapy

Interventions

Drug therapy for HFOTHER

Titration of HF meds in an aggressive out patient manner following guideline direction

SOC
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

NT-proBNP arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02467, United States

Location

Related Publications (11)

  • 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.

    PMID: 29438982DERIVED

  • Motiwala 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.

    PMID: 25777344DERIVED

  • Gandhi 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.

    PMID: 25728731DERIVED

  • Gaggin 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.

    PMID: 24622120DERIVED

  • Motiwala 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.

    PMID: 24309956DERIVED

  • Gaggin 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.

    PMID: 24114865DERIVED

  • Bhardwaj 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.

    PMID: 23137512DERIVED

  • Weiner 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.

    PMID: 23132825DERIVED

  • Gaggin 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.

    PMID: 22858078DERIVED

  • Januzzi 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.

    PMID: 22018299DERIVED

  • Bhardwaj 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.

    PMID: 20362709DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • James L. Januzzi, MD, FACC

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 10, 2006

First Posted

July 12, 2006

Study Start

September 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

US(1)