Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00351390
Other study ID # 2004-P-001447/12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2005
Est. completion date June 2009

Study information

Verified date March 2019
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 152
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Drug therapy for HF
Titration of HF meds in an aggressive out patient manner following guideline direction
NT-proBNP guided HF therapy
Standard of care drug therapy following guideline direction, plus adjustment of medication titrated to achieve NT-proBNP <1000 pg/mL

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Roche Diagnostics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on total cardiovascular events One year
Secondary Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of outpatient decompensated HF. One year
Secondary 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
Secondary 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
Secondary Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy on the reduction of all cause mortality. One year
Secondary Ability of cTnT and hsCRP, independently as well as together with NT-proBNP, to predict cardiovascular endpoints. One year
Secondary Effect of Standard of Care therapy versus Standard of Care plus NT-proBNP targeted therapy alone on patient quality of life. One year
Secondary Cost benefits of NT-proBNP guided HF therapy versus standard of care. One year
See also
  Status Clinical Trial Phase
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Recruiting NCT04703842 - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction Phase 1/Phase 2
Terminated NCT05594940 - Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Recruiting NCT04982081 - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection Phase 1
Completed NCT04394754 - Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure N/A
Active, not recruiting NCT01385176 - Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) N/A
Not yet recruiting NCT05516290 - Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
Completed NCT02885636 - Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial Phase 3
Terminated NCT02788656 - Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan) Phase 4
Terminated NCT02205411 - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation N/A
Completed NCT02252757 - Assess Measurements of Wireless Cardiac Output Device N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Withdrawn NCT00346177 - Stem Cell Study for Patients With Heart Failure Phase 2
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Active, not recruiting NCT01058837 - SCD-HeFT 10 Year Follow-up N/A
Completed NCT00957541 - Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device Phase 2