Dataset Information

Biomarkers to Assess Right Heart Pressures in Recipients of a Heart Transplant: A Proof-of-Concept Study.

ABSTRACT: Background:This proof-of-concept study investigated the feasibility of using biomarkers to monitor right heart pressures (RHP) in heart transplanted (HTx) patients. Methods:In 298 patients, we measured 7.6 years post-HTx mean pressures in the right atrium (mRAP) and pulmonary artery (mPAP) and capillaries (mPCWP) along with plasma high-sensitivity troponin T (hsTnT), a marker of cardiomyocyte injury, and the multidimensional urinary classifiers HF1 and HF2, mainly consisting of dysregulated collagen fragments. Results:In multivariable models, mRAP and mPAP increased with hsTnT (per 1-SD, +0.91 and +1.26 mm Hg; P < 0.0001) and with HF2 (+0.42 and +0.62 mm Hg; P ? 0.035), but not with HF1. mPCWP increased with hsTnT (+1.16 mm Hg; P < 0.0001), but not with HF1 or HF2. The adjusted odds ratios for having elevated RHP (mRAP, mPAP or mPCWP ?10, ?24, ?17 mm Hg, respectively) were 1.99 for hsTnT and 1.56 for HF2 (P ? 0.005). In detecting elevated RHPs, areas under the curve were similar for hsTnT and HF2 (0.63 vs 0.65; P = 0.66). Adding hsTnT continuous or per threshold or HF2 continuous to a basic model including all covariables did not increase diagnostic accuracy (P ? 0.11), whereas adding HF2 per optimized threshold increased both the integrated discrimination (+1.92%; P = 0.023) and net reclassification (+30.3%; P = 0.010) improvement. Conclusions:Correlating RHPs with noninvasive biomarkers in HTx patients is feasible. However, further refinement and validation of such biomarkers is required before their clinical application can be considered.

SUBMITTER: Huang QF

PROVIDER: S-EPMC5959348 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Biomarkers to Assess Right Heart Pressures in Recipients of a Heart Transplant: A Proof-of-Concept Study.

Huang Qi-Fang QF Trenson Sander S Zhang Zhen-Yu ZY Van Keer Jan J Van Aelst Lucas N L LNL Yang Wen-Yi WY Nkuipou-Kenfack Esther E Thijs Lutgarde L Wei Fang-Fei FF Mujaj Blerim B Ciarka Agnieszka A Droogné Walter W Vanhaecke Johan J Janssens Stefan S Van Cleemput Johan J Mischak Harald H Staessen Jan A JA

Transplantation direct 20180423 5

<h4>Background</h4>This proof-of-concept study investigated the feasibility of using biomarkers to monitor right heart pressures (RHP) in heart transplanted (HTx) patients.<h4>Methods</h4>In 298 patients, we measured 7.6 years post-HTx mean pressures in the right atrium (mRAP) and pulmonary artery (mPAP) and capillaries (mPCWP) along with plasma high-sensitivity troponin T (hsTnT), a marker of cardiomyocyte injury, and the multidimensional urinary classifiers HF1 and HF2, mainly consisting of dy ...[more]

PMID: 29796417

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Project description:BACKGROUND:Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities (eg, hypertension, diabetes). These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients' physiological data. This technology is also relatively inexpensive, has an intuitive interface, and provides the capability for real-time personalized feedback to help motivate patient self-efficacy. Automated summary reports of patients' adherence and blood pressure can easily be uploaded to providers' networks helping reduce clinical inertia by reducing regimen alteration time. OBJECTIVE:The aim of this study was to assess the feasibility, acceptability, and preliminary outcomes of a prototype mobile health (mHealth) medication and blood pressure (BP) self-management system for kidney transplant patients with uncontrolled hypertension. METHODS:A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design. The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback. A 3-month proof-of-concept randomized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray. Participants randomized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging. Controls received standard of care and their adherence continued to be monitored with the medication tray reminders turned off. Providers received weekly summary reports of patient medication adherence and BP readings. RESULTS:Participation and retention rates were 41/55 (75%) and 31/34 (91%), respectively. The prototype system appears to be safe, highly acceptable, and useful to patients and providers. Compared to the standard care control group (SC), the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations. Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the standard care group (7 adjustments in 5 patients versus 3 adjustments in 3 patients) during the 3-month trial based on the information provided in the weekly reports. CONCLUSIONS:These data support the acceptability and feasibility of the prototype mHealth system. Further trials with larger sample sizes and additional biomarkers (eg, whole blood medication levels) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control after kidney transplantation over longer time periods. TRIAL REGISTRATION:Clinicaltrials.gov NCT01859273; http://clinicaltrials.gov/ct2/show/NCT01859273 (Archived by WebCite at http://www.webcitation.org/6IqfCa3A3).

Project description:BACKGROUND:The language gap between health consumers and health professionals has been long recognized as the main hindrance to effective health information comprehension. Although providing health information access in consumer health language (CHL) is widely accepted as the solution to the problem, health consumers are found to have varying health language preferences and proficiencies. To simplify health documents for heterogeneous consumer groups, it is important to quantify how CHLs are different in terms of complexity among various consumer groups. OBJECTIVE:This study aimed to propose an informatics framework (consumer health language complexity [CHELC]) to assess the complexity differences of CHL using syntax-level, text-level, term-level, and semantic-level complexity metrics. Specifically, we identified 8 language complexity metrics validated in previous literature and combined them into a 4-faceted framework. Through a rank-based algorithm, we developed unifying scores (CHELC scores [CHELCS]) to quantify syntax-level, text-level, term-level, semantic-level, and overall CHL complexity. We applied CHELCS to compare posts of each individual on online health forums designed for (1) the general public, (2) deaf and hearing-impaired people, and (3) people with autism spectrum disorder (ASD). METHODS:We examined posts with more than 4 sentences of each user from 3 health forums to understand CHL complexity differences among these groups: 12,560 posts from 3756 users in Yahoo! Answers, 25,545 posts from 1623 users in AllDeaf, and 26,484 posts from 2751 users in Wrong Planet. We calculated CHELCS for each user and compared the scores of 3 user groups (ie, deaf and hearing-impaired people, people with ASD, and the public) through 2-sample Kolmogorov-Smirnov tests and analysis of covariance tests. RESULTS:The results suggest that users in the public forum used more complex CHL, particularly more diverse semantics and more complex health terms compared with users in the ASD and deaf and hearing-impaired user forums. However, between the latter 2 groups, people with ASD used more complex words, and deaf and hearing-impaired users used more complex syntax. CONCLUSIONS:Our results show that the users in 3 online forums had significantly different CHL complexities in different facets. The proposed framework and detailed measurements help to quantify these CHL complexity differences comprehensively. The results emphasize the importance of tailoring health-related content for different consumer groups with varying CHL complexities.

Project description:It remains difficult to predict and to measure the efficacy of pharmacological immunosuppression. We hypothesized that measuring the B-cell repertoire would enable assessment of the overall level of immunosuppression after heart transplantation.In this proof-of-concept study, we implemented a molecular-barcode-based immune repertoire sequencing assay that sensitively and accurately measures the isotype and clonal composition of the circulating B cell repertoire. We used this assay to measure the temporal response of the B cell repertoire to immunosuppression after heart transplantation. We selected a subset of 12 participants from a larger prospective cohort study (ClinicalTrials.gov NCT01985412) that is ongoing at Stanford Medical Center and for which enrollment started in March 2010. This subset of 12 participants was selected to represent post-heart-transplant events, with and without acute rejection (six participants with moderate-to-severe rejection and six without). We analyzed 130 samples from these patients, with an average follow-up period of 15 mo. Immune repertoire sequencing enables the measurement of a patient's net state of immunosuppression (correlation with tacrolimus level, r = -0.867, 95% CI -0.968 to -0.523, p = 0.0014), as well as the diagnosis of acute allograft rejection, which is preceded by increased immune activity with a sensitivity of 71.4% (95% CI 30.3% to 94.9%) and a specificity of 82.0% (95% CI 72.1% to 89.1%) (cell-free donor-derived DNA as noninvasive gold standard). To illustrate the potential of immune repertoire sequencing to monitor atypical post-transplant trajectories, we analyzed two more patients, one with chronic infections and one with amyloidosis. A larger, prospective study will be needed to validate the power of immune repertoire sequencing to predict rejection events, as this proof-of-concept study is limited to a small number of patients who were selected based on several criteria including the availability of a large number of samples and the absence or presence of rejection events.If confirmed in larger, prospective studies, the method described here has potential applications in the tailored management of post-transplant immunosuppression and, more broadly, as a method for assessing the overall activity of the immune system.

Dataset Information

Biomarkers to Assess Right Heart Pressures in Recipients of a Heart Transplant: A Proof-of-Concept Study.

Publications

Biomarkers to Assess Right Heart Pressures in Recipients of a Heart Transplant: A Proof-of-Concept Study.

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