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Supplemental thiamine for the treatment of acute heart failure syndrome: a randomized controlled trial.

ABSTRACT: BACKGROUND:The purpose of this pilot study was to determine if a definitive clinical trial of thiamine supplementation was warranted in patients with acute heart failure. We hypothesized that thiamine, when added to standard of care, would improve dyspnea (primary outcome) in hospitalized patients with acute heart failure. Peak expiratory flow rate, type B natriuretic peptide, free fatty acids, glucose, hospital length of stay, as well as 30-day rehospitalization and mortality were pre-planned secondary outcome measures. METHODS:This was a blinded experimental study at two urban academic hospitals. Consecutive patients admitted from the Emergency Department with a primary diagnosis of acute heart failure were recruited over 2?years. Patients on a daily dietary supplement were excluded. Randomization was stratified by type B natriuretic peptide and diabetes medication categories. Subjects received study drug (100?mg thiamine or placebo) in the evening of their first and second day. Outcome measures were obtained 8?h after study drug infusion. Dyspnea was measured on a 100-mm visual analog scale sitting up on oxygen, sitting up off oxygen, and lying supine off oxygen with 0 indicating no dyspnea. Data were analyzed using mixed-models as well as linear, negative binomial and logistic regression models to assess the impact of group on outcome measures. RESULTS:Of 130 subjects randomized, 118 had evaluable data (55 in the control and 63 in the treatment groups), 89% in both groups were adjudicated to have primarily AHF. Thiamine values increased significantly in the treatment group and were unchanged in the control group. One patient had thiamine deficiency. Only dyspnea measured sitting upright on oxygen differed significantly by group over time. No change was found for the other measures of dyspnea and all of the secondary measures. CONCLUSIONS:In mild-moderate acute heart failure patients without thiamine deficiency, a standard dosing regimen of thiamine did not improve dyspnea, biomarkers, or other clinical parameters. TRIAL REGISTRATION:ClinicalTrials.gov: NCT00680706 , May 20, 2008 (retrospectively registered).

SUBMITTER: Smithline HA

PROVIDER: S-EPMC6501378 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Supplemental thiamine for the treatment of acute heart failure syndrome: a randomized controlled trial.

Smithline Howard A HA Donnino Michael M Blank Fidela S J FSJ Barus Richard R Coute Ryan A RA Knee Alexander B AB Visintainer Paul P

BMC complementary and alternative medicine 20190506 1

<h4>Background</h4>The purpose of this pilot study was to determine if a definitive clinical trial of thiamine supplementation was warranted in patients with acute heart failure. We hypothesized that thiamine, when added to standard of care, would improve dyspnea (primary outcome) in hospitalized patients with acute heart failure. Peak expiratory flow rate, type B natriuretic peptide, free fatty acids, glucose, hospital length of stay, as well as 30-day rehospitalization and mortality were pre-p ...[more]

PMID: 31060559

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Project description:BackgroundCognitive behavioral therapy for insomnia (CBT-I) is an efficacious treatment for people with chronic insomnia, including those with heart failure (HF). Treatment fidelity evaluation is needed to ensure study validity and reliability.ObjectiveThe aim of this study was to apply the National Institutes of Health Behavioral Change Consortium framework to ensure adequate treatment fidelity in a randomized controlled trial of CBT-I for people with stable HF.MethodsWe describe strategies to ensure treatment fidelity in study design, provider training, and treatment delivery. We measured treatment receipt (observation and self-report) and enactment of CBT-I strategies (self-report and actigraphy). We used the Dysfunctional Beliefs and Attitudes About Sleep Scale and the Sleep Disturbance Questionnaire to indicate sleep-related beliefs and cognitions. We computed descriptive statistics for demographic characteristics, treatment receipt, and enactment variables. We compared baseline and post-intervention dichotomous sleep behaviors using the two-sided Wilcoxon rank-sum test. We calculated the root mean square of successive difference in time of sleep onset and midpoint (actigraphy) to indicate day-by-day variability in bed and wake times.ResultsMost participants completed the CBT-I intervention and follow-up assessments and attended each group or make-up session. Most correctly computed their sleep efficiency and completed their homework. Most participants used the sleep tracker and reported using strategies to improve their sleep schedules. There was a significant decrease in actigraph-measured light intensity during the 30 minutes and 1 hour before bedtime between baseline and post-intervention and no statistically significant changes in light intensity after waking or in nap frequency. Most of those who woke during the night got out of bed, consistent with recommendations. There were significant improvements on all of the Dysfunctional Beliefs and Attitudes About Sleep items and total score and all but one item on the Sleep Disturbance Questionnaire.DiscussionPreserved treatment fidelity may explain the large and sustained effects in people with HF found in our trial. Further research is needed to evaluate CBT-I's effectiveness and implementation strategies among people with HF in real-world clinical settings.

Project description:ImportanceSmall studies suggest that low-dose dopamine or low-dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction; however, neither strategy has been rigorously tested.ObjectiveTo test the 2 independent hypotheses that, compared with placebo, addition of low-dose dopamine (2 μg/kg/min) or low-dose nesiritide (0.005 μg/kg/min without bolus) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction.Design, setting, and participantsMulticenter, double-blind, placebo-controlled clinical trial (Renal Optimization Strategies Evaluation [ROSE]) of 360 hospitalized patients with acute heart failure and renal dysfunction (estimated glomerular filtration rate of 15-60 mL/min/1.73 m2), randomized within 24 hours of admission. Enrollment occurred from September 2010 to March 2013 across 26 sites in North America.InterventionsParticipants were randomized in an open, 1:1 allocation ratio to the dopamine or nesiritide strategy. Within each strategy, participants were randomized in a double-blind, 2:1 ratio to active treatment or placebo. The dopamine (n = 122) and nesiritide (n = 119) groups were independently compared with the pooled placebo group (n = 119).Main outcomes and measuresCoprimary end points included 72-hour cumulative urine volume (decongestion end point) and the change in serum cystatin C from enrollment to 72 hours (renal function end point).ResultsCompared with placebo, low-dose dopamine had no significant effect on 72-hour cumulative urine volume (dopamine, 8524 mL; 95% CI, 7917-9131 vs placebo, 8296 mL; 95% CI, 7762-8830 ; difference, 229 mL; 95% CI, -714 to 1171 mL; P = .59) or on the change in cystatin C level (dopamine, 0.12 mg/L; 95% CI, 0.06-0.18 vs placebo, 0.11 mg/L; 95% CI, 0.06-0.16; difference, 0.01; 95% CI, -0.08 to 0.10; P = .72). Similarly, low-dose nesiritide had no significant effect on 72-hour cumulative urine volume (nesiritide, 8574 mL; 95% CI, 8014-9134 vs placebo, 8296 mL; 95% CI, 7762-8830; difference, 279 mL; 95% CI, -618 to 1176 mL; P = .49) or on the change in cystatin C level (nesiritide, 0.07 mg/L; 95% CI, 0.01-0.13 vs placebo, 0.11 mg/L; 95% CI, 0.06-0.16; difference, -0.04; 95% CI, -0.13 to 0.05; P = .36). Compared with placebo, there was no effect of low-dose dopamine or nesiritide on secondary end points reflective of decongestion, renal function, or clinical outcomes.Conclusion and relevanceIn participants with acute heart failure and renal dysfunction, neither low-dose dopamine nor low-dose nesiritide enhanced decongestion or improved renal function when added to diuretic therapy.Trial registrationclinicaltrials.gov Identifier: NCT01132846.

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Supplemental thiamine for the treatment of acute heart failure syndrome: a randomized controlled trial.

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Supplemental thiamine for the treatment of acute heart failure syndrome: a randomized controlled trial.

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