Rationale, design, and baseline characteristics of a Program to Assess and Review Trending INformation and Evaluate CorRelation to Symptoms in Patients with Heart Failure (PARTNERS HF)

doi:10.1016/j.ahj.2008.06.036

American Heart Journal

Volume 156, Issue 5, November 2008, Pages 833-839.e2

https://doi.org/10.1016/j.ahj.2008.06.036 Get rights and content

Background

Heart failure (HF) is a common medical problem with significant morbidity and mortality. Recently, device-based therapy, cardiac resynchronization therapy (CRT), implantable cardioverter-defibrillators (ICDs), and combined CRT and ICD have become established therapies in patients with HF receiving standard medical therapy. Contemporary implantable devices are able to continuously monitor, store, and display long-term diagnostic information. Daily diagnostic information includes intrathoracic impedance, patient activity, hours spent in atrial tachycardia/fibrillation, ventricular rate during atrial tachycardia/fibrillation, ventricular tachyarrhythmia episodes, ICD shocks, day and night heart rate, and heart rate variability.

Methods

PARTNERS HF is a prospective, nonrandomized, multicenter observational study. Patient data are collected at baseline and at 3, 6, 9, and 12 months. Our objectives are to assess the relationship between the (1) diagnostic data and HF-related events, (2) diagnostic data and HF-related health care utilizations, and (3) OptiVol (Medtronic, Inc, Minneapolis, MN) fluid monitoring diagnostic data and clinically relevant pulmonary congestion events in a subset of patients. The study has enrolled 1,024 patients with a commercially available combined CRT and ICD system at 100 sites in the United States. Participants will be followed for 1 year.

Results

Enrollment was completed in January 2007. Key baseline characteristics include the following: mean age of 68.4 ± 10.8 years, 32% female, 13% people of color, 64% with ischemic HF, and >80% of patients reported to be on recommended HF medications at enrollment.

Conclusions

The results of PARTNERS HF could help identify device diagnostic information that may provide an early recognition of impending HF-related events.

Section snippets

Methods

The PARTNERS HF study is a prospective, nonrandomized, multicenter observational study designed to identify relationships between the diagnostic data included in the Cardiac Compass report and HF-related events.

Key patient inclusion and exclusion criteria are shown in Table I. Total enrollment for the study is 1,024 patients with a commercially available CRT-D system. Patients will be followed for 1 year at 100 sites in the United States. Enrollment began in June 2004 and concluded in 2007,

Results

Patient baseline characteristics for all but 1 of the 1,024 enrolled patients are shown in Table III. Most patients reported ischemic HF etiology at enrollment (64%). Either type 1 or type 2 diabetes was present in 40% of patients. The percentages of patients who reported chronic obstructive pulmonary disease and AF were 19% and 27%, respectively. Most patients were using recommended pharmacologic therapy including 81% on angiotensin-converting enzyme inhibitor or angiotensin receptor blockers,

Discussion

The PARTNERS HF study is the largest known registry evaluating the ability of device diagnostics to predict HF clinical events in a broad representative population of patients with HF. A total of 1,024 patients has been enrolled, providing an updated view of patient selection for CRT devices.

Our initial patient baseline characteristics are similar to other CRT studies evaluating patients with moderate to severe HF. We enrolled a sizeable proportion of women and people of color. Heart failure

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Hemoglobin, exercise training, and health status in patients with chronic heart failure (from the HF-ACTION randomized controlled trial)
2013, American Journal of Cardiology
Citation Excerpt :
HF-ACTION was a multicenter randomized controlled trial of exercise training in outpatients with HF. A complete description of the study design and exercise training protocol has been published previously.2 Patients were enrolled at 82 centers in the United States, Canada, and France.
Anemia is common in patients with chronic heart failure (HF), with a prevalence ranging from 10% to 56%, and may be a risk factor for poor outcomes. Anemia in HF remains poorly understood, with significant gaps in its impact on health-related quality of life (HRQoL), with most studies in HF being retrospective or from registries. The purpose of this study was to explore the relation of hemoglobin (Hgb) with HRQoL and training-induced changes in HRQoL in a cohort of patients in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Using data from HF-ACTION, a randomized controlled trial of exercise training in patients with HF and low left ventricular ejection fractions, HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and annually up to 4 years. Treatment group effects on HRQoL were estimated using linear mixed models according to the intention-to-treat principle. It was hypothesized that baseline Hgb would be correlated with baseline KCCQ scales and that Hgb would moderate the beneficial effect of exercise training on HRQoL. Hgb level was not significantly correlated with baseline HRQoL. Baseline Hgb did not moderate the beneficial effect of exercise training on KCCQ overall or subscales relative to usual care. In conclusion, in the HF-ACTION cohort, there was no correlation with baseline Hgb and baseline HRQoL as measured by the KCCQ. In addition, the beneficial effects of HRQoL from exercise training were not modulated by baseline Hgb.
Benefit of exercise therapy for systolic heart failure in relation to disease severity and etiology-findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training study
2011, American Heart Journal
Citation Excerpt :
A complete description of the study design and ET protocol has been published previously.7
This post hoc analysis of the HF-ACTION cohort explores the primary and secondary results of the HF-ACTION study by etiology and severity of illness.
HF-ACTION randomized stable outpatients with reduced left ventricular (LV) function and heart failure (HF) symptoms to either supervised exercise training plus usual care or to usual care alone. The primary outcome was all-cause mortality or all-cause hospitalization; secondary outcomes included all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or HF hospitalization. The interaction between treatment and risk variable, etiology or severity as determined by risk score, New York Heart Association class, and duration of cardiopulmonary exercise test was examined in a Cox proportional hazards model for all clinical end points.
There was no interaction between etiology and treatment for the primary outcome (P = .73), cardiovascular (CV) mortality or CV hospitalization (P = .59), or CV mortality or HF hospitalization (P = .07). There was a significant interaction between etiology and treatment for the outcome of mortality (P = .03), but the interaction was no longer significant when adjusted for HF-ACTION adjustment model predictors (P = .08). There was no significant interaction between treatment effect and severity, except a significant interaction between cardiopulmonary exercise duration and training was identified for the primary outcome of all-cause mortality or all-cause hospitalization.
Consideration of symptomatic (New York Heart Association classes II to IV) patients with HF with reduced LV function for participation in an exercise training program should be made independent of the cause of HF or the severity of the symptoms.
Combined Heart Failure Device Diagnostics Identify Patients at Higher Risk of Subsequent Heart Failure Hospitalizations. Results From PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) Study
2010, Journal of the American College of Cardiology
Citation Excerpt :
The design of the PARTNERS HF Study was described in a previous publication (10).
We sought to determine the utility of combined heart failure (HF) device diagnostic information to predict clinical deterioration of HF in patients with systolic left ventricular dysfunction.
Some implantable devices continuously monitor HF device diagnostic information, but data are limited on the ability of combined HF device diagnostics to predict HF events.
The PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) was a prospective, multicenter observational study in patients receiving cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillators. HF events were independently adjudicated. A combined HF device diagnostic algorithm was developed on an independent dataset. The algorithm was considered positive if a patient had 2 of the following abnormal criteria during a 1-month period: long atrial fibrillation duration, rapid ventricular rate during atrial fibrillation, high (≥60) fluid index, low patient activity, abnormal autonomics (high night heart rate or low heart rate variability), or notable device therapy (low CRT pacing or implantable cardioverter-defibrillator shocks), or if they only had a very high (≥100) fluid index. We used univariate and multivariable analyses to determine predictors of subsequent HF events within a month.
We analyzed data from 694 CRT defibrillator patients who were followed for 11.7 ± 2 months. Ninety patients had 141 adjudicated HF hospitalizations with pulmonary congestion at least 60 days after implantation. Patients with a positive combined HF device diagnostics had a 5.5-fold increased risk of HF hospitalization with pulmonary signs or symptoms within the next month (hazard ratio: 5.5, 95% confidence interval: 3.4 to 8.8, p < 0.0001), and the risk remained high after adjusting for clinical variables (hazard ratio: 4.8, 95% confidence interval: 2.9 to 8.1, p < 0.0001).
Monthly review of HF device diagnostic data identifies patients at a higher risk of HF hospitalizations within the subsequent month. (PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure; NCT00279955).
Will Artificial Intelligence Provide Answers to Current Gaps and Needs in Chronic Heart Failure?
2023, Applied Sciences (Switzerland)
Implantable Cardiovascular Devices: Current and Emerging Technologies for Remote Heart Failure Monitoring
2023, Cardiology in Review
Retrospective application of Program to Access and Review Trending iNformation and Evaluate coRrelation to Symptoms in patients with Heart Failure criteria for the remote management of patients with cardiac resynchronisation therapy
2017, Journal of Telemedicine and Telecare

View all citing articles on Scopus

: Trial registration no. NCT00279955.

: This study is sponsored by Medtronic, Inc, Minneapolis, MN.

^d: For a list of the PARTNERS HF Study Committees & Investigators see Appendix A online.

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Trial DesignRationale, design, and baseline characteristics of a Program to Assess and Review Trending INformation and Evaluate CorRelation to Symptoms in Patients with Heart Failure (PARTNERS HF)

Background

Methods

Results

Conclusions

Section snippets

Methods

Results

Discussion

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Trial Design
Rationale, design, and baseline characteristics of a Program to Assess and Review Trending INformation and Evaluate CorRelation to Symptoms in Patients with Heart Failure (PARTNERS HF)