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NT-proBNP stratified follow up in outpatients heart failure clinics: A Randomized Danish Multicenter Study Morten Schou, MD, PhD Principal Investigator.

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Presentation on theme: "NT-proBNP stratified follow up in outpatients heart failure clinics: A Randomized Danish Multicenter Study Morten Schou, MD, PhD Principal Investigator."— Presentation transcript:

1 NT-proBNP stratified follow up in outpatients heart failure clinics: A Randomized Danish Multicenter Study Morten Schou, MD, PhD Principal Investigator Hillerod University Hospital, Copenhagen The Danish Heart Failure Clinics Network On behalf on the NorthStar Steering Group: Finn Gustafsson, Lars Videbaek, Per R Hildebrandt and Morten Schou

2 Roche Diagnostics International, Basel, Schwitzerland Research grant Roche Diagnostics, Copenhagen, Denmark Research grant Merck, Sharp and Dohme, Copenhagen, Denmark Research grant

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4 Objectives: To determine the effectiveness of a continued heart failure clinic intervention. To determine whether NT-proBNP could identify patients with particular benefit of continued follow up. Population: Predefined clinical stable systolic heart failure patients on optimal medical therapy. Primary outcome: Time to death or a CV hospitalization

5 GPEcho LabDept of Cardiology/ Internal Medicine Heart failure clinic (HFC): Education Exercise Etiologi ACE-I/ARB´s BB Aldosterone antagonists Adjusting doses of diuretics CRT and/or ICD Remain symptomatic Considered Stable HTX ? LVAD ? (2 centers) Scientific Question: Where should these patients be followed ? HFC ? GP (routine in DK) ? Only high risk patients in the HFC ? e.g identified by NT- proBNP ?

6 In the NorthStar Study the patients were on optimal therapy before randomization and only little room was left for a lowering strategy. (EMPHASIS, REVERSE and MADIT-CRT were initiated before NorthStar) We, therefore, created a clinical checklist, which should be used if NT-proBNP increased > 30 % compared to the randomization visit even the patient did not become more symptomatic.

7 Clinically stable systolic heart failure patients on optimal medical therapy benefit from long term follow up in a HFC. The benefit is driven by an effect only in high risk patients identified by NT-proBNP > 1000 pg/ml. (prespecified interaction analysis) High risk patients identified by NT-proBNP > 1000 pg/ml benefit further from NT-proBNP monitoring.

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9 PROBE design (Prospective Randomized Open-labeled Blinded Endpoint) Multicenter (18 sites) Investigator Initiated

10 The patients visit the HFC with 1-3 months intervals based on the investigators discretion

11 M. Schou et al. (NorthStar DesignPaper): AHJ 2008

12 Simple randomization with strata* (*due to the prespecified interaction analysis (NT-proBNP*HFC))

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14 N = 6180 patients had at least one visit in one of the HFC in the randomization period (registry) N= 1628 patients considered eligible N = 1120 patients randomized N = 460 patients allocated to GP N= 660 patients allocated to HFC (N=461) or HFC+NT-proBNP (N=199 ) N = 508 excluded Lost to follow up (N=0) Informed consent withdrawn due to traffiic accident (N=1) Lost to follow up (N=0) Informed consent withdrawn due to traffiic accident (N=1) N=659 patients included in final analyses N= 460 patients included in final analyses Registry Enrollment Allocation Follow up Analysis Lost to follow up (N=0)

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16 Demografic variables, %GP (=460) N= 257 (NT-proBNP < 1000 ) and N=203 (NT-proBNP > 1000) HFC (=461) N= 253 (NT-proBNP < 1000) and N=208 (NT-proBNP > 1000) P-value Age, years Female Sex, % LVEF, % NYHA II-III, % Ischemic Cardiomyopathy, % eGFR, ml/min/1.73 m NT-proBNP, pg/ml Hosp with 12 months, % ACE/ARB, randomization, % ACE/ARB, target dose (of all patients), % BB, randomization, % BB, target dose (of all all patients), % Aldo-anta, randomization, % Loop diuretics, mg (median) ICD, % (only IHD in DK) CRT, %

17 * Only patients with NT-proBNP > 1000 pg/ml

18 Demografic variables, %HFC Usual Care N=208 HFC NT-proBNP-moni N=199 P value Age, years Female Sex, % LVEF, % NYHA II-III, % Ischemic Cardiomyopathy, % eGFR, ml/min/1.73 m NT-proBNP, pg/ml Hosp with 12 months ACE/ARB, randomization, % ACE/ARB, target dose (of all patients), % BB, randomization, % BB, target dose (of all all patients), % Aldo, randomization, % Loop diuretics, mg (median) ICD, % CRT, %

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20 HR: 1.17, 95 % CI : , P = Blue: GP (N=460) HFC: Black (N=461) Events: 159 Events: 177

21 HR: 0.94; 95 CI: ; P = HFC*NT-proBNP > 1000 pg/ml; P = (test for heterogeneity) Blue: GP (N= 257 and N= 203) HFC: Black (N=253 and N=208)

22 * Only patients with NT-proBNP > 1000 pg/ml

23 HR: 0.94; 95 CI: ; P = HR: 0.95, 95 % CI: , P = HFC (N=208) Usual care: Black HFC (N=199) NT-proBNP: Red

24 Time to death Time to a cardiovascular hospitalization Time to a heart failure hospitalization Time to an over all-hospitalization Minnesota Living with Heart Failure Score NYHA class NT-proBNP Patients admitted, admissions and admission days P > 0.05 for all: -HFC vs. GP -NT-proBNP stratified hypothesis - HFC vs HFC+NT-proBNP

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26 Clinically stable systolic heart failure patients on optimal medical therapy do not benefit from long term follow up in a HFC. A subgroup of high-risk patients identified by NT-proBNP do not benefit from long term follow up in a HFC. The present NT-proBNP monitoring concept does not improve long term clinical outcome.

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28 Clinically stable HF patients can be referred back to their GP. Adherence in GP was suprisingly good – wrong hypothesis ? NT-proBNP identified the high-risk patients and did it´s job, but our intervention(s) could not improve outcome for these patients – wrong concept(s) ? We did not power the study to look at HF hospitalizations – wrong endpoint ? Our patients were primarily NYHA class I-II – will NT-proBNP monitoring only work in NYHA class III-IV – wrong patients ? Type II error - Bad luck ?

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