Heart FailureGUIDE-ITNCT01685840
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment
A study testing Biomarker-guided care NT-proBNP in people with Heart Failure, run by Duke University at 46 sites in 2 countries.
Trial summary
The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Biomarker-guided care NT-proBNP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 894 participants
- Where
- 46 sitesin 2 countries
- Study dates
- Dec 2012to 20 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age 18 years or older
- Most recent LVEF to be ≤ 40% by any method within 12 months of randomization.
- High risk heart failure as defined by the following criteria:
- A Heart Failure Event in the prior 12 months, defined as any one of the following:
- HF Hospitalization
- Treatment in the Emergency Department (or equivalent) for Heart Failure
Show all 10Show fewer
- Outpatient treatment for heart failure with intravenous diuretics
- AND
- NT-proBNP greater than 2000 pg/mL or BNP greater than 400 pg/mL at any time during the 30 days prior to randomization
- Willing to provide informed consent
Who cannot join
- Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days
- Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device
- Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
- Severe stenotic valvular disease
- Anticipated heart transplantation or ventricular assist device within 12 months
- Chronic inotropic therapy
Show all 12Show fewer
- Complex congenital heart disease
- End stage renal disease with renal replacement therapy
- Non cardiac terminal illness with expected survival less than 12 months
- Women who are pregnant or planning to become pregnant
- Inability to comply with planned study procedures
- Enrollment or planned enrollment in another clinical trial
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States40 sites
AnMed Health Medical Center
Anderson, South Carolina, 29621
Emory University
Atlanta, Georgia, 30322
University Cardiology Associates, LLC
Augusta, Georgia, 30901
Fox Valley Clinical Research Center, LLC
Aurora, Illinois, 60504
University of Maryland
Baltimore, Maryland, 21201
Metropolitan Cardiovascular Consultants
Beltsville, Maryland, 20705
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Medical Center
Boston, Massachusetts, 02215
New York Methodist Hospital
Brooklyn, New York, 11215
Capitol Area Research, LLC
Camp Hill, Pennsylvania, 17011
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
Cardiovascular Associates of the Delaware Valley
Cherry Hill, New Jersey, 08034
Cardiovascular Associates, Ltd.
Chesapeake, Virginia, 23320
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Holy Cross Medical Group
Coral Springs, Florida, 33065
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, 27401
Pentucket Medical Associates
Haverhill, Massachusetts, 01830
The Heart Center PC
Huntsville, Alabama, 35801
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Intermountain Medical Center
Murray, Utah, 84157
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Yale University School of Medicine
New Haven, Connecticut, 06510
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, 15212
Mayo Clinic
Rochester, Minnesota, 55905
Sutter Memorial Hospital
Sacramento, California, 95819
University of California San Diego Medical Center
San Diego, California, 92037
Saratoga Cardiology Associates
Saratoga Springs, New York, 12866
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, 08080
Washington University School of Medicine
St Louis, Missouri, 63112
Bronx-Lebanon Hospital Center
The Bronx, New York, 10457
Jacobi Medical Center
The Bronx, New York, 10461
Albert Einstein University Hospital
The Bronx, New York, 10467
Canada6 sites
Foothills Medical Centre
Calgary, Alberta, T2N 4Z6
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Hamilton Health Sciences
Hamilton, Ontario, L8L 2X2
St. Michaels Hospital
Toronto, Ontario, M5B 1W8
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
Saint Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
About this study
Official title: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.
Read the detailed description
Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.
- Conditions
- Heart Failure
- Being tested
- Usual Care, Biomarker-guided care NT-proBNP
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
Usual Care
Biomarker-guided care NT-proBNPDevice
Device: NT-proBNP
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Experimental | Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. Receives: Other: Usual Care |
| Biomarker-Guided Care | Experimental | Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. Receives: Device: Biomarker-guided care NT-proBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CV Death or Heart Failure Hospitalization
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
Measured: 24 Months
Secondary outcomes (17)
All-cause Mortality
All-cause mortality by treatment arm
Measured: 24 months
Cumulative Morbidity
Days alive and not hospitalized for CV reasons
Measured: 24 months
CV Death
CV death by treatment arm
Measured: 24 months
Number of Hospitalizations for First Heart Failure
First Heart Failure Hospitalization
Measured: 24 months
Number of Hospitalizations for Recurrent Heart Failure
Recurrent Heart Failure Hospitalization
Measured: 24 months
Percentage of Patients With Moderate to Severe Depression
Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D).
CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher.
Measured: Baseline, 3,6, 12 and 24 months
Duke Activity Status Index (DASI)
The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Measured: Baseline, 3, 6, 12 and 24 months
EQ-5D Health Index
The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).
Measured: Baseline, 3, 6, 12 and 24 months
EQ-5D Visual Analog Scale
The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.
Measured: Baseline, 3, 6, 12 and 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Measured: Baseline, 3, 6,12 and 24 months
Short Form-36 (SF-36) General Health Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Measured: Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Mental Health Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Measured: Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Social Functioning Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Measured: Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Physiological Functioning Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Measured: Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Vitality Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Measured: Baseline, 3, 6, 12 and 24 months
Resource Utilization
Observed Resource Use
Measured: 24 months
Resource Utilization Cost
Observed Hospital-Based Cost.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startDec 2012
- Primary completion20 Sep 2016
- Study completion20 Sep 2016
Why it stopped: Project was stopped due to futility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)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 Duke UniversityThe 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
- 894 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michael Felker, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685840
- Sponsor's protocol ID
- Pro00033097
- Acronym
- GUIDE-IT
- Status last verified
- Nov 2017
- First submitted
- 12 Sep 2012
- Last updated
- 12 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Augusto SN Jr, Wu Y, Chaikijurajai T, Hazen SL, Tang WHW. Abbreviated Duke Activity Status Index for Risk Stratification in Heart Failure. Am J Cardiol. 2025 Feb 15;237:54-59. doi: 10.1016/j.amjcard.2024.11.029. Epub 2024 Nov 26.
PubMed 39603580Fuery MA, Leifer ES, Samsky MD, Sen S, O'Connor CM, Fiuzat M, Ezekowitz J, Pina I, Whellan D, Mark D, Felker GM, Desai NR, Januzzi JL, Ahmad T. Prognostic Impact of Repeated NT-proBNP Measurements in Patients With Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2024 Mar;12(3):479-487. doi: 10.1016/j.jchf.2023.11.007. Epub 2023 Dec 20.
PubMed 38127049Ezekowitz JA, Alemayehu W, Rathwell S, Grant AD, Fiuzat M, Whellan DJ, Ahmad T, Adams K, Pina IL, Cooper LS, Januzzi JL, Leifer ES, Mark D, O'Connor CM, Felker GM. The influence of comorbidities on achieving an N-terminal pro-b-type natriuretic peptide target: a secondary analysis of the GUIDE-IT trial. ESC Heart Fail. 2022 Feb;9(1):77-86. doi: 10.1002/ehf2.13692. Epub 2021 Nov 16.
PubMed 34784657Chouairi F, Fuery MA, Mullan CW, Caraballo C, Sen S, Maulion C, Wilkinson ST, Surti T, McCullough M, Miller PE, Pacor J, Leifer ES, Felker GM, Velazquez EJ, Fiuzat M, O'Connor CM, Januzzi JL, Desai NR, Ahmad T. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial. J Card Fail. 2021 Dec;27(12):1359-1366. doi: 10.1016/j.cardfail.2021.06.008. Epub 2021 Jun 22.
PubMed 34166799Fuery MA, Chouairi F, Januzzi JL, Moe GW, Caraballo C, McCullough M, Miller PE, Reinhardt SW, Clark K, Oseran A, Milner A, Pacor J, Kahn PA, Singh A, Ravindra N, Guha A, Vadlamani L, Kulkarni NS, Fiuzat M, Felker GM, O'Connor CM, Ahmad T, Ezekowitz J, Desai NR. Intercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure. JACC Heart Fail. 2021 Jul;9(7):497-505. doi: 10.1016/j.jchf.2021.02.011. Epub 2021 May 12.
PubMed 33992564Daubert MA, Yow E, Barnhart HX, Pina IL, Ahmad T, Leifer E, Cooper L, Desvigne-Nickens P, Fiuzat M, Adams K, Ezekowitz J, Whellan DJ, Januzzi JL, O'Connor CM, Felker GM. Differences in NT-proBNP Response and Prognosis in Men and Women With Heart Failure With Reduced Ejection Fraction. J Am Heart Assoc. 2021 May 18;10(10):e019712. doi: 10.1161/JAHA.120.019712. Epub 2021 May 6.
PubMed 33955231Parcha V, Patel N, Kalra R, Suri SS, Arora G, Wang TJ, Arora P. Obesity and Serial NT-proBNP Levels in Guided Medical Therapy for Heart Failure With Reduced Ejection Fraction: Insights From the GUIDE-IT Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e018689. doi: 10.1161/JAHA.120.018689. Epub 2021 Mar 23.
PubMed 33754794Fiuzat M, Ezekowitz J, Alemayehu W, Westerhout CM, Sbolli M, Cani D, Whellan DJ, Ahmad T, Adams K, Pina IL, Patel CB, Anstrom KJ, Cooper LS, Mark D, Leifer ES, Felker GM, Januzzi JL, O'Connor CM. Assessment of Limitations to Optimization of Guideline-Directed Medical Therapy in Heart Failure From the GUIDE-IT Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):757-764. doi: 10.1001/jamacardio.2020.0640.
PubMed 32319999Januzzi JL Jr, Ahmad T, Mulder H, Coles A, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Mark DB, Pina IL, Passmore G, Whellan DJ, Cooper LS, Leifer ES, Desvigne-Nickens P, Felker GM, O'Connor CM. Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 Sep 3;74(9):1205-1217. doi: 10.1016/j.jacc.2019.06.055.
PubMed 31466618O'Connor C, Fiuzat M, Mulder H, Coles A, Ahmad T, Ezekowitz JA, Adams KF, Pina IL, Anstrom KJ, Cooper LS, Mark DB, Whellan DJ, Januzzi JL Jr, Leifer ES, Felker GM. Clinical factors related to morbidity and mortality in high-risk heart failure patients: the GUIDE-IT predictive model and risk score. Eur J Heart Fail. 2019 Jun;21(6):770-778. doi: 10.1002/ejhf.1450. Epub 2019 Mar 27.
PubMed 30919549Daubert MA, Adams K, Yow E, Barnhart HX, Douglas PS, Rimmer S, Norris C, Cooper L, Leifer E, Desvigne-Nickens P, Anstrom K, Fiuzat M, Ezekowitz J, Mark DB, O'Connor CM, Januzzi J, Felker GM. NT-proBNP Goal Achievement Is Associated With Significant Reverse Remodeling and Improved Clinical Outcomes in HFrEF. JACC Heart Fail. 2019 Feb;7(2):158-168. doi: 10.1016/j.jchf.2018.10.014. Epub 2019 Jan 2.
PubMed 30611722Mark DB, Cowper PA, Anstrom KJ, Sheng S, Daniels MR, Knight JD, Baloch KN, Davidson-Ray L, Fiuzat M, Januzzi JL Jr, Whellan DJ, Pina IL, Ezekowitz JA, Adams KF, Cooper LS, O'Connor CM, Felker GM. Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure. J Am Coll Cardiol. 2018 Nov 27;72(21):2551-2562. doi: 10.1016/j.jacc.2018.08.2184.
PubMed 30466512Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL Jr, Mark DB, Pina IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne-Nickens P, O'Connor CM. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):713-720. doi: 10.1001/jama.2017.10565.
PubMed 28829876Felker GM, Ahmad T, Anstrom KJ, Adams KF, Cooper LS, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL, Leifer ES, Mark DB, Desvigne-Nickens P, Paynter G, Pina IL, Whellan DJ, O'Connor CM. Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure. JACC Heart Fail. 2014 Oct;2(5):457-65. doi: 10.1016/j.jchf.2014.05.007. Epub 2014 Sep 3.
PubMed 25194287
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
- ClinicalTrials.gov ID
- NCT01685840
- Acronym / sponsor ID
- GUIDE-IT / Pro00033097
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Project was stopped due to futility
- Enrolment
- 894 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Dec 2012
- Primary completion
- 20 Sep 2016 (actual)
- Study completion
- 20 Sep 2016 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Posted 12 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.
Detailed description
Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Experimental | Other: Usual CareUsual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure. |
| Biomarker-Guided Care | Experimental | Device: Biomarker-guided care NT-proBNPDevice: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 years or older
- Most recent LVEF to be ≤ 40% by any method within 12 months of randomization.
- High risk heart failure as defined by the following criteria:
- HF Hospitalization
- Treatment in the Emergency Department (or equivalent) for Heart Failure
Key exclusion criteria (12 listed)
- Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days
- Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device
- Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
- Severe stenotic valvular disease
- Anticipated heart transplantation or ventricular assist device within 12 months
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 |
|---|---|---|
| Usual CareUsual Care | Other | Usual Care |
| Biomarker-guided care NT-proBNPDevice: NT-proBNP | Device | Biomarker-Guided Care |
Primary outcome
CV Death or Heart Failure Hospitalization
Time frame: 24 Months
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
17 secondary outcomes
All-cause Mortality
Time frame: 24 months
Cumulative Morbidity
Time frame: 24 months
CV Death
Time frame: 24 months
Number of Hospitalizations for First Heart Failure
Time frame: 24 months
Number of Hospitalizations for Recurrent Heart Failure
Time frame: 24 months
Percentage of Patients With Moderate to Severe Depression
Time frame: Baseline, 3,6, 12 and 24 months
Duke Activity Status Index (DASI)
Time frame: Baseline, 3, 6, 12 and 24 months
EQ-5D Health Index
Time frame: Baseline, 3, 6, 12 and 24 months
EQ-5D Visual Analog Scale
Time frame: Baseline, 3, 6, 12 and 24 months
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
Time frame: Baseline, 3, 6,12 and 24 months
Short Form-36 (SF-36) General Health Subscale
Time frame: Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Mental Health Subscale
Time frame: Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Social Functioning Subscale
Time frame: Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Physiological Functioning Subscale
Time frame: Baseline, 3, 6, 12 and 24 months
Short Form-36 (SF-36) Vitality Subscale
Time frame: Baseline, 3, 6, 12 and 24 months
Resource Utilization
Time frame: 24 months
Resource Utilization Cost
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39603580Augusto SN Jr, Wu Y, Chaikijurajai T, Hazen SL, Tang WHW. Abbreviated Duke Activity Status Index for Risk Stratification in Heart Failure. Am J Cardiol. 2025 Feb 15;237:54-59. doi: 10.1016/j.amjcard.2024.11.029. Epub 2024 Nov 26.
- Derived from this study: PubMed 38127049Fuery MA, Leifer ES, Samsky MD, Sen S, O'Connor CM, Fiuzat M, Ezekowitz J, Pina I, Whellan D, Mark D, Felker GM, Desai NR, Januzzi JL, Ahmad T. Prognostic Impact of Repeated NT-proBNP Measurements in Patients With Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2024 Mar;12(3):479-487. doi: 10.1016/j.jchf.2023.11.007. Epub 2023 Dec 20.
- Derived from this study: PubMed 34784657Ezekowitz JA, Alemayehu W, Rathwell S, Grant AD, Fiuzat M, Whellan DJ, Ahmad T, Adams K, Pina IL, Cooper LS, Januzzi JL, Leifer ES, Mark D, O'Connor CM, Felker GM. The influence of comorbidities on achieving an N-terminal pro-b-type natriuretic peptide target: a secondary analysis of the GUIDE-IT trial. ESC Heart Fail. 2022 Feb;9(1):77-86. doi: 10.1002/ehf2.13692. Epub 2021 Nov 16.
- Derived from this study: PubMed 34166799Chouairi F, Fuery MA, Mullan CW, Caraballo C, Sen S, Maulion C, Wilkinson ST, Surti T, McCullough M, Miller PE, Pacor J, Leifer ES, Felker GM, Velazquez EJ, Fiuzat M, O'Connor CM, Januzzi JL, Desai NR, Ahmad T. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial. J Card Fail. 2021 Dec;27(12):1359-1366. doi: 10.1016/j.cardfail.2021.06.008. Epub 2021 Jun 22.
- Derived from this study: PubMed 33992564Fuery MA, Chouairi F, Januzzi JL, Moe GW, Caraballo C, McCullough M, Miller PE, Reinhardt SW, Clark K, Oseran A, Milner A, Pacor J, Kahn PA, Singh A, Ravindra N, Guha A, Vadlamani L, Kulkarni NS, Fiuzat M, Felker GM, O'Connor CM, Ahmad T, Ezekowitz J, Desai NR. Intercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure. JACC Heart Fail. 2021 Jul;9(7):497-505. doi: 10.1016/j.jchf.2021.02.011. Epub 2021 May 12.
- Derived from this study: PubMed 33955231Daubert MA, Yow E, Barnhart HX, Pina IL, Ahmad T, Leifer E, Cooper L, Desvigne-Nickens P, Fiuzat M, Adams K, Ezekowitz J, Whellan DJ, Januzzi JL, O'Connor CM, Felker GM. Differences in NT-proBNP Response and Prognosis in Men and Women With Heart Failure With Reduced Ejection Fraction. J Am Heart Assoc. 2021 May 18;10(10):e019712. doi: 10.1161/JAHA.120.019712. Epub 2021 May 6.
- Derived from this study: PubMed 33754794Parcha V, Patel N, Kalra R, Suri SS, Arora G, Wang TJ, Arora P. Obesity and Serial NT-proBNP Levels in Guided Medical Therapy for Heart Failure With Reduced Ejection Fraction: Insights From the GUIDE-IT Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e018689. doi: 10.1161/JAHA.120.018689. Epub 2021 Mar 23.
- Derived from this study: PubMed 32319999Fiuzat M, Ezekowitz J, Alemayehu W, Westerhout CM, Sbolli M, Cani D, Whellan DJ, Ahmad T, Adams K, Pina IL, Patel CB, Anstrom KJ, Cooper LS, Mark D, Leifer ES, Felker GM, Januzzi JL, O'Connor CM. Assessment of Limitations to Optimization of Guideline-Directed Medical Therapy in Heart Failure From the GUIDE-IT Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):757-764. doi: 10.1001/jamacardio.2020.0640.
- Derived from this study: PubMed 31466618Januzzi JL Jr, Ahmad T, Mulder H, Coles A, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Mark DB, Pina IL, Passmore G, Whellan DJ, Cooper LS, Leifer ES, Desvigne-Nickens P, Felker GM, O'Connor CM. Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 Sep 3;74(9):1205-1217. doi: 10.1016/j.jacc.2019.06.055.
- Derived from this study: PubMed 30919549O'Connor C, Fiuzat M, Mulder H, Coles A, Ahmad T, Ezekowitz JA, Adams KF, Pina IL, Anstrom KJ, Cooper LS, Mark DB, Whellan DJ, Januzzi JL Jr, Leifer ES, Felker GM. Clinical factors related to morbidity and mortality in high-risk heart failure patients: the GUIDE-IT predictive model and risk score. Eur J Heart Fail. 2019 Jun;21(6):770-778. doi: 10.1002/ejhf.1450. Epub 2019 Mar 27.
- Derived from this study: PubMed 30611722Daubert MA, Adams K, Yow E, Barnhart HX, Douglas PS, Rimmer S, Norris C, Cooper L, Leifer E, Desvigne-Nickens P, Anstrom K, Fiuzat M, Ezekowitz J, Mark DB, O'Connor CM, Januzzi J, Felker GM. NT-proBNP Goal Achievement Is Associated With Significant Reverse Remodeling and Improved Clinical Outcomes in HFrEF. JACC Heart Fail. 2019 Feb;7(2):158-168. doi: 10.1016/j.jchf.2018.10.014. Epub 2019 Jan 2.
- Derived from this study: PubMed 30466512Mark DB, Cowper PA, Anstrom KJ, Sheng S, Daniels MR, Knight JD, Baloch KN, Davidson-Ray L, Fiuzat M, Januzzi JL Jr, Whellan DJ, Pina IL, Ezekowitz JA, Adams KF, Cooper LS, O'Connor CM, Felker GM. Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure. J Am Coll Cardiol. 2018 Nov 27;72(21):2551-2562. doi: 10.1016/j.jacc.2018.08.2184.
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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.
Michael Felker, MD principal investigator
Duke University
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomarker-guided care NT-proBNP in people with Heart Failure, run by Duke University at 46 sites in 2 countries.
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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
CV Death or Heart Failure Hospitalization (time frame: 24 Months). 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 NCT01685840, which also lists 14 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 12 Dec 2017.