Wrist Actigraphy Predicts Outcome in Patients with Pulmonary Hypertension

Ulrich, Silvia; Fischler, Manuel; Speich, Rudolf; Bloch, Konrad E.

doi:10.1159/000342351

Cited by 42 publications

(49 citation statements)

References 34 publications

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“…This is in line with other studies that found an association of low NYHA class with better HRQoL and high NYHA class with worse HRQoL in PH patients [35,36]. In line with others, we could confirm a correlation between HRQoL and exercise performance [4,5,6]. …”

Section: Discussionsupporting

confidence: 93%

“…Cognitive deficits were found in more than half of PAH patients and mainly presented as worsening in verbal learning, delayed verbal memory, reduced executive function and failed fine motor scores. A decline in cognitive function might also be associated with reduced health-related quality of life (HRQoL), which itself is known to be associated with disease progression [3,4,5,6]. …”

Section: Introductionmentioning

confidence: 99%

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Disease-Targeted Treatment Improves Cognitive Function in Patients with Precapillary Pulmonary Hypertension

Somaini¹,

Stamm²,

Müller-Mottet³

et al. 2015

Respiration

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Background: Patients with pulmonary hypertension (PH) may suffer from cognitive deficits that potentially relate to reduced oxygen delivery and cerebral tissue oxygenation (CTO). Objective: To evaluate the hypothesis that cognitive function improves with therapy, along with improved CTO. Methods: Twenty incident patients with arterial or chronic thromboembolic PH had CTO monitoring by near-infrared spectroscopy during diagnostic right heart catheterization. Cognitive tests [Trail Making Tests (TMTs), Victoria Stroop tests and the Five-Point Test (5PT)], the 6-min walk distance (6MWD) test, New York Heart Association (NYHA) class and health-related quality of life (HRQoL) were assessed and repeated after 3 months of disease-targeted medication. Results: At baseline, 45% of PH patients had cognitive deficits. At 3 months, the patients had improved on the TMT A and the Stroop 2 test [37 s (27; 55) versus 30 s (24; 42), p < 0.05, and 18 s (16; 22) versus 16 s (15; 20), p < 0.01], whereas CTO remained unchanged. Arterial oxygen saturation, NYHA class, 6MWD and HRQoL had also improved. Baseline CTO was the strongest predictor of cognitive function, even in multivariate analysis including age, 6MWD and HRQoL. Improvements in cognitive function were not associated with changes in CTO. Conclusions: In patients with PH, 3 months of disease-targeted medication resulted in better cognitive function. Although CTO was the strongest predictor of cognitive function at baseline, it did not change during target therapy. The results of this pilot study should be confirmed in an adequately powered controlled trial.

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Section: Discussionsupporting

confidence: 93%

Section: Introductionmentioning

confidence: 99%

Disease-Targeted Treatment Improves Cognitive Function in Patients with Precapillary Pulmonary Hypertension

Somaini¹,

Stamm²,

Müller-Mottet³

et al. 2015

Respiration

Self Cite

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Section: Discussionmentioning

confidence: 99%

“…37–39 A recent pilot study in adults with severe PAH suggests that actigraphy data are associated with survival, and may be helpful for longitudinal assessments of changes in disease status. 39 The actigraphy activity counts were also correlated with 6MWD test in adults with PAH (Spearman rank correlation = 0.72, P <0.001). 40 However, studies need to be conducted in pediatric PAH patients in order to explore the possibility of using actigraphy as an efficacy end point in pediatric PAH trials and drug development.…”

Section: Discussionmentioning

confidence: 99%

Reliable and developmentally appropriate study end points are needed to achieve drug development for treatment of pediatric pulmonary arterial hypertension

et al. 2016

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OBJECTIVE To identify suitable end points and surrogates for pediatric pulmonary arterial hypertension (PAH) as the lack of developmentally appropriate end point and clinical trials contribute to the unmet medical need. STUDY DESIGN Reviewed the efficacy end points and surrogates for all trials (1995 to 2013) that were submitted to the Food and Drug Administration (FDA) to support the approval of PAH therapy and conducted literature search. RESULTS An increase in the 6 min walking distance (6MWD) was used as a primary end point in 8/9 adult PAH trials. This end point is not suitable for infants and young children because of performance limitations and lack of control data. One adult PAH trial used time to the first morbidity or mortality event as a primary end point, which could potentially be used in pediatric PAH trials. In the sildenafil pediatric PAH trial, the change in pulmonary vascular resistance index or mean pulmonary artery pressure was used as a surrogate for the 6MWD to assess exercise capacity. However, two deaths and three severe adverse events during the catheterizations made this an unacceptably high-risk surrogate. The INOmax persistent pulmonary hypertension of the newborn trial used a reduction in initiation of extracorporeal membrane oxygenation treatment as a primary end point, which is not feasible for other pediatric PAH trials. A Literature review revealed none of the existing noninvasive markers are fully validated as surrogates to assess PAH efficacy and long-term safety. CONCLUSIONS For pediatric PAH trials, clinical end points are acceptable, and novel validated surrogates would be helpful. FDA seeks collaboration with academia, industry and parents to develop other suitable and possibly more efficient efficacy end points to facilitate pediatric PAH drug development.

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“…Both Mainguy et al [165] and Pugh et al [166] demonstrated a reduction in daily life physical activities and increased sedentary time in PAH. Preliminary data published by Ulrich et al [167] have suggested poorer survival in those with reduced daytime activity and Frantz et al [168] provided evidence that treatment can improve activity levels.…”

Section: Field Exercise Testsmentioning

confidence: 99%

The Role of Exercise Testing in the Modern Management of Pulmonary Arterial Hypertension

Johnson

Thomson

2014

Diseases

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A culture of exercise testing is firmly embedded in the management of pulmonary arterial hypertension (PAH) but its clinical relevance and utility have recently been under some debate. The six minute walk test (6MWT) has been used as a primary outcome measure to enable the licensing of many of the medications used for this condition. Recent reviews have questioned the validity of this test as a surrogate of clinical outcomes. At the same time, other questions are emerging where exercise testing may be the solution. With the rise in understanding of genetic markers of idiopathic PAH (IPAH), the screening of an otherwise healthy population for incipient pulmonary hypertension (PH) will be required. The proliferation in treatment choices and identification of populations with PH where PAH treatment is not indicated, such as left heart and lung disease, requires more definitive differentiation from patients with PAH. There is a continuing question about the existence and clinical relevance of exercise induced PAH as a cause of unexplained dyspnoea and fatigue and as a latent phase of resting PH. This review presents a summary and critical analysis of the current role of exercise testing in PAH and speculates on future trends.

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Wrist Actigraphy Predicts Outcome in Patients with Pulmonary Hypertension

Cited by 42 publications

References 34 publications

Disease-Targeted Treatment Improves Cognitive Function in Patients with Precapillary Pulmonary Hypertension

Disease-Targeted Treatment Improves Cognitive Function in Patients with Precapillary Pulmonary Hypertension

Reliable and developmentally appropriate study end points are needed to achieve drug development for treatment of pediatric pulmonary arterial hypertension

The Role of Exercise Testing in the Modern Management of Pulmonary Arterial Hypertension

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