Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Aims: The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials. Methods and Results: Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure < 100 mmHg (n = 1127), estimated glomerular filtration rate < 30 mL/min/1.73 m2 (n = 528), and treated with sacubitril‐valsartan at baseline (n = 1594). Conclusions: GALACTIC‐HF enrolled a well‐treated, high‐risk population from both inpatient and outpatient settings, which will provide a definitive evaluation of the efficacy and safety of this novel therapy, as well as informing its potential future implementation

Evaluating the Impact of Mindfulness Meditation to Reduce Stress and Anxiety in a Pregnant Population

Maternal stress and anxiety levels during pregnancy are highly prevalent and are associated with numerous poor outcomes, the most serious of which are the increased rates of infant mortality, preterm birth, and low birth weight infants. There is evidence that mindfulness training is beneficial in reducing perinatal stress and anxiety. However, traditional mindfulness training entails in-person meetings, which creates barriers, limiting accessibility. The purpose of this study was to determine if a more accessible form of mindfulness meditation (MM) training, specifically, the Headspace app, can help reduce stress and anxiety during pregnancy. To evaluate this, a longitudinal, single-arm pilot study was implemented with 20 pregnant women, who were instructed to practice meditation twice/day during the month-long trial. Validated scales were used to measure study participant’s levels of stress, anxiety, and pregnancy anxiety pre-and post-intervention. Physiological measures reflective of stress (heart rate/heart rate variability [HR/HRV] and sleep) were collected via the Oura Ring, a highly accurate sleep tracking device. Analysis indicated statistically significant reductions in self-report levels of stress (p=0.005), anxiety (p=0.011), and pregnancy anxiety (p=0.0001). Analysis of physiological data on HR/HRV and sleep, using hierarchical linear modeling, yielded a statistically significant decrease in 1 of 6 HR/HRV metrics, the low-frequency (LF) power band of the HRV; which decreased by 13% (p=0.006). LF is reflective of both sympathetic and parasympathetic activities, with lower values indicating relaxation/reduced mental stress. There was a trend towards statistical significance in two other metrics. The first is the ratio of the low frequency/high frequency (LF/HF) band, reflecting parasympathetic dominance/relaxed state, which decreased by 2% (p=0.086). The second is sleep which improved by 2% (p=0.092). In addition, 65% of study participants believed their sleep improved during the trial, and 95% felt that learning mindfulness helped with other aspects of their lives. Finally, retention of participants in the study was 100%, and adherence to the intervention was very good; with 65% of participants completing about two-thirds of the intervention, and 50% competing ≥95%. This study found evidence to support that the Headspace app is an impactful mindfulness meditation intervention to aid in stress and anxiety reduction for the pregnant population

Evaluating the Impact of Mindfulness Meditation to Reduce Stress and Anxiety in a Pregnant Population

Maternal stress and anxiety levels during pregnancy are highly prevalent and are associated with numerous poor outcomes, the most serious of which are the increased rates of infant mortality, preterm birth, and low birth weight infants. There is evidence that mindfulness training is beneficial in reducing perinatal stress and anxiety. However, traditional mindfulness training entails in-person meetings, which creates barriers, limiting accessibility. The purpose of this study was to determine if a more accessible form of mindfulness meditation (MM) training, specifically, the Headspace app, can help reduce stress and anxiety during pregnancy. To evaluate this, a longitudinal, single-arm pilot study was implemented with 20 pregnant women, who were instructed to practice meditation twice/day during the month-long trial. Validated scales were used to measure study participant’s levels of stress, anxiety, and pregnancy anxiety pre-and post-intervention. Physiological measures reflective of stress (heart rate/heart rate variability [HR/HRV] and sleep) were collected via the Oura Ring, a highly accurate sleep tracking device. Analysis indicated statistically significant reductions in self-report levels of stress (p=0.005), anxiety (p=0.011), and pregnancy anxiety (p=0.0001). Analysis of physiological data on HR/HRV and sleep, using hierarchical linear modeling, yielded a statistically significant decrease in 1 of 6 HR/HRV metrics, the low-frequency (LF) power band of the HRV; which decreased by 13% (p=0.006). LF is reflective of both sympathetic and parasympathetic activities, with lower values indicating relaxation/reduced mental stress. There was a trend towards statistical significance in two other metrics. The first is the ratio of the low frequency/high frequency (LF/HF) band, reflecting parasympathetic dominance/relaxed state, which decreased by 2% (p=0.086). The second is sleep which improved by 2% (p=0.092). In addition, 65% of study participants believed their sleep improved during the trial, and 95% felt that learning mindfulness helped with other aspects of their lives. Finally, retention of participants in the study was 100%, and adherence to the intervention was very good; with 65% of participants completing about two-thirds of the intervention, and 50% competing ≥95%. This study found evidence to support that the Headspace app is an impactful mindfulness meditation intervention to aid in stress and anxiety reduction for the pregnant population

Evaluating the Impact of an App-Delivered Mindfulness Meditation Program to Reduce Stress and Anxiety During Pregnancy: Pilot Longitudinal Study.

BACKGROUND: Stress and anxiety during pregnancy are extremely prevalent and are associated with numerous poor outcomes, among the most serious of which are increased rates of preterm birth and low birth weight infants. Research supports that while in-person mindfulness training is effective in reducing pregnancy stress and anxiety, there are barriers limiting accessibility. OBJECTIVE: The aim of this paper is to determine if mindfulness meditation training with the Headspace app is effective for stress and anxiety reduction during pregnancy. METHODS: A longitudinal, single-arm trial was implemented with 20 pregnant women who were instructed to practice meditation via the Headspace app twice per day during the month-long trial. Validated scales were used to measure participants levels of stress and anxiety pre- and postintervention. Physiological measures reflective of stress (heart rate variability and sleep) were collected via the Oura Ring. RESULTS: Statistically significant reductions were found in self-reported levels of stress (P=.005), anxiety (P=.01), and pregnancy anxiety (P<.0001). Hierarchical linear modeling revealed a statistically significant reduction in the physiological data reflective of stress in 1 of 6 heart rate variability metrics, the low-frequency power band, which decreased by 13% (P=.006). A total of 65% of study participants (n=13) reported their sleep improved during the trial, and 95% (n=19) stated that learning mindfulness helped with other aspects of their lives. Participant retention was 100%, with 65% of participants (n=13) completing about two-thirds of the intervention, and 50% of participants (n=10) completing ≥95%. CONCLUSIONS: This study found evidence to support the Headspace app as an effective intervention to aid in stress and anxiety reduction during pregnancy

Evaluating the Impact of an App-Delivered Mindfulness Meditation Program to Reduce Stress and Anxiety During Pregnancy: Pilot Longitudinal Study

BackgroundStress and anxiety during pregnancy are extremely prevalent and are associated with numerous poor outcomes, among the most serious of which are increased rates of preterm birth and low birth weight infants. Research supports that while in-person mindfulness training is effective in reducing pregnancy stress and anxiety, there are barriers limiting accessibility. ObjectiveThe aim of this paper is to determine if mindfulness meditation training with the Headspace app is effective for stress and anxiety reduction during pregnancy. MethodsA longitudinal, single-arm trial was implemented with 20 pregnant women who were instructed to practice meditation via the Headspace app twice per day during the month-long trial. Validated scales were used to measure participant’s levels of stress and anxiety pre- and postintervention. Physiological measures reflective of stress (heart rate variability and sleep) were collected via the Oura Ring. ResultsStatistically significant reductions were found in self-reported levels of stress (P=.005), anxiety (P=.01), and pregnancy anxiety (P<.0001). Hierarchical linear modeling revealed a statistically significant reduction in the physiological data reflective of stress in 1 of 6 heart rate variability metrics, the low-frequency power band, which decreased by 13% (P=.006). A total of 65% of study participants (n=13) reported their sleep improved during the trial, and 95% (n=19) stated that learning mindfulness helped with other aspects of their lives. Participant retention was 100%, with 65% of participants (n=13) completing about two-thirds of the intervention, and 50% of participants (n=10) completing ≥95%. ConclusionsThis study found evidence to support the Headspace app as an effective intervention to aid in stress and anxiety reduction during pregnancy