View clinical trials related to Hypotension, Orthostatic.
Filter by:SynABPM 2 proof-of-efficacy is a retrospective, multicentre, observational study performed in patients affected by hypotensive reflex syncope who had performed two ABPMs, one before and another after any therapeutical intervention aimed to increase arterial blood pressure
Rationale: Systolic hypertension represents the leading risk for burden of disease among older adults (age >70 years), with an increasing prevalence due to the increase in lifespan. Antihypertensive drug treatment (AHT) is beneficial in fit (non-frail) older adults, with substantial (≈40 %) risk reductions for cardiovascular events and mortality. Scarce evidence exists on the risks of adverse effects related to AHT. It has been suggested in medical literature that AHT in frail elderly might cause cerebral hypoperfusion and/or orthostatic hypotension. Therefore, current guidelines advise clinicians to be more cautious regarding treatment targets in this population. However, the evidence for these adverse effects is limited to observational and cross-sectional data and opinion pieces. In contrast to the suggestion of potential adverse effects of AHT in elderly, recent experimental data and secondary analyses of clinical trials do not provide support for this statement. However, evidence in frail older patients remains scarce. Studies that directly examine the safety of AHT with regard to cerebral hemodynamics and orthostatic tolerance in frail elderly are needed to inform potential changes in current treatment guidelines and prevent undertreatment of hypertension in frail older patients. Objective: To examine the impact of medication induced systolic BP (SBP) reductions ≥10 mmHg, while reaching a treatment target of ≤140 mmHg, on cerebral blood flow (CBF) in frail elderly with untreated or uncontrolled systolic hypertension at baseline. We hypothesise that these blood pressure lowering targets (which are consistent with clinical guidelines for non-frail older patients) are not accompanied by detrimental reductions in CBF (i.e. >10% from baseline). Study design: An explorative observational study will be performed to examine the effects of medication induced SBP reductions ≥10 mmHg to office SBP ≤140 mmHg on CBF in frail elderly with untreated or uncontrolled hypertension. Participants will be treated as in usual patient care for older adults with hypertension. Participants will undergo one baseline assessment before exposure to (additional) AHT, followed by in duplo follow-up assessments 6-10 weeks after the start of AHT. The in duplo follow-up evaluations will be performed on separate days within 2 weeks while continuing treatment. Study population: Twelve frail (Clinical Frailty Scale 4-7) elderly (age ≥70 years) with untreated or uncontrolled systolic hypertension (office SBP ≥150 mmHg) that will be subjected to (additional) AHT as part of regular care. Main study parameters/endpoints: The change in resting CBF from baseline to follow-up (i.e. the average of the in duplo follow-up assessments). Secondary outcomes relate to cerebrovascular autoregulation (CA) and orthostatic tolerance. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will be subjected to AHT, essentially identical to what is considered 'guideline care', while their wellbeing will be monitored closely. Since all study procedures and used measurement techniques are non-invasive, the nature and extent of burden and risks associated with participation and measurements are negligible.
Levodopa is a precursor of dopamine and is the treatment of choice to treat the motor symptoms of Parkinson's disease (PD); however, the effect of levodopa on cardiovascular autonomic function in PD is poorly understood. Orthostatic hypotension has been documented as a potential side effect of levodopa. As a result, clinicians may be reluctant to prescribe levodopa in patients with PD with neurogenic orthostatic hypotension (PD+OH), which leads to suboptimal management of motor symptoms. On the other hand, other studies failed to show any clear relationship between levodopa and orthostatic hypotension in patients with PD. Important limitations of prior studies include the lack of detailed investigation of baroreflex cardiovagal and sympathetic noradrenergic functions and the fact that the same patients were not tested on and off levodopa. The investigators propose to investigate the effects of levodopa on cardiovascular autonomic function in patients with PD+OH and PD without neurogenic orthostatic hypotension (PD-OH) by performing standardized autonomic testing in the same patients on and off levodopa.
Clinical and biological assessments of volemia are challenging in older patients as they are more likely to present non-typical signs. Point of care ultrasonography (POCUS) using heart and lung exploration is a relevant tool to assess volemia in adults with little data in older adults. The primary objective of the study is to evaluate feasibility of positional POCUS in aging patients. The secondary objectives are to assess the variability of measurements between decubitus and sitting position.
The two scientific societies FADOI and SIIA have decided to start a collaborative study protocol that, through the application of a simple and homogeneous method to diagnose orthostatic hypotension, aims to estimate prevalence, conditions associates and outcomes in a cohort of patients admitted to Internal Medicine Departments and with known or newly diagnosed arterial hypertension.
The purpose of the study is to understand how blood pressure, heart rate, and symptoms of low blood pressure (such as dizziness or nausea) are affected by positional changes and exercise when on land or in the water for people who tend to experience orthostatic hypotension.
This is a prospective single-center randomized crossover control study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation in patients with known or suspected orthostatic hypotension.
This study looks to characterize autonomic nervous system dysfunction after spinal cord injury and identify the potential role that transcutaneous spinal cord stimulation may play at altering neuroregulation. The autonomic nervous system plays key parts in regulation of blood pressure, skin blood flow, and bladder health- all issues that individuals with spinal cord injury typically encounter complications. For both individuals with spinal cord injury and uninjured controls, experiments will utilize multiple parallel recordings to identify how the autonomic nervous system is able to inhibit and activate sympathetic signals. The investigators anticipate that those with autonomic dysfunction after spinal cord injury will exhibit abnormalities in these precise metrics. In both study populations, transcutaneous spinal cord stimulation will be added, testing previously advocated parameters to alter autonomic neuroregulation. In accomplishing this, the investigators hope to give important insights to how the autonomic nervous system works after spinal cord injury and if it's function can be improved utilizing neuromodulation.
This study will comprise of two phases, an observational phase and a treatment phase. In the observational phase the specific aims are: 1. To determine the presence and regional distribution of microglial activation, as assessed by 18F-PBR06 PET, in subjects with MSA as compared to healthy controls, at baseline and at 6-9 months' follow-up. 2. To assess the relationship between microglial activation and clinical progression at baseline and follow-up. In the treatment phase the specific aims of the study are: The specific aims of the study are: 1. To assess whether verdiperstat (BHV-3241) reduces 18F-PBR06 PET signal, and thus microglial activation and inflammation, in well-characterized MSA patients. 2. To assess the relationship between PET changes and clinical progression at baseline and follow-up in patients treated with verdiperstat. 3. To assess the relationship between PET changes and volumetric brain MRI at baseline and follow-up in patients treated with verdiperstat. Currently there is no known disease modifying therapy for MSA. Recently, the drug verdiperstat (BHV-3241) has appeared in the investigational arena specifically for the indication of Multiple System Atrophy. Verdiperstat (BHV-3241) is currently being used in a phase 3 active drug trial at Massachusetts Hospital. Verdiperstat (BHV-3241) is known to target Myeloperoxidase, an enzyme implicated in neuroinflammation, a major driver in disease pathogenesis. Our previous study (IRB protocol #2016P002373) demonstrated that applying TSPO (translator protein) PET imaging enabled us to track changes in neuroinflammation and thus provide a viable biomarker for disease progression. In this pilot study, the investigators aim to assess the effect of an investigational drug, verdiperstat (BHV-3241) on microglial activation in MSA patients using [F-18]PBR06 and to link it with clinical and morphometric MRI brain changes following treatment.
Orthostatic hypotension (OH), which consists in a significant reduction in blood pressure levels upon standing from a seated position, may affect approximately one in three patients with Parkinson's disease (PD). It usually presents as dizziness, lightheadedness, feeling faint, or feeling like you might black out while standing. This can significantly impact the quality of life (QoL) of PD patients, resulting in difficulties with balance, walking, and increased risk of falls. The main aim of this study is to evaluate whether the use of technological devices (a computerized system for analyzing abnormalities in walking in clinical settings and a wearable sensor to detect changes in postural unsteadiness in the home environment) may improve the detection of complications and the response to medical therapies for OH in patients with PD.