CLINICAL TRIAL

Accelerometer for Hypotension, Orthostatic

Recruiting · 18+ · All Sexes · Nashville, TN

This study is evaluating whether an activity monitor can be used to assess the efficacy of a medication for orthostatic hypotension.

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About the trial for Hypotension, Orthostatic

Eligible Conditions
Hypotension, Orthostatic · Multiple System Atrophy · Neurogenic Orthostatic Hypotension (nOH) · Shy-Drager Syndrome · Autonomic Failure · Parkinsonian Disorders · Pure Autonomic Failure · Hypotension · Orthostatic; Hypotension, Parkinsonism

Treatment Groups

This trial involves 2 different treatments. Accelerometer is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
placebo pill
DRUG
Accelerometer
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Midodrine or atomoxetine pill
DRUG
Accelerometer
DEVICE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
placebo pill
2005
Completed Phase 4
~350
Accelerometer
2020
Completed Phase 2
~520

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The doctor is diagnosing the patient with one of three possible diseases: Multiple Systems Atrophy, Pure Autonomic Failure, or Parkinson's disease with neurogenic orthostatic hypotension. show original
Neurogenic orthostatic hypotension is a condition in which there is a sudden, significant drop in blood pressure after standing up, due to a problem with the autonomic nervous system show original
Some patients who are taking medication for neurogenic orthostatic hypotension (a condition that causes a sudden drop in blood pressure when standing up), experience some improvement in their symptoms, but still have symptoms ( scored a 1 to 5 on the Orthostatic hypotension symptom assessment [OHSA] scale while taking medication). show original
A study of male and female subjects age 40-80 found that there was a significant difference between the two groups in the incidence of cardiovascular events. show original
Patients who are able to remain with their caregiver during the study will have an easier time participating in the study. show original
Able and willing to give consent that is informed. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 7 days of treatment or placebo period
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days of treatment or placebo period
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 7 days of treatment or placebo period.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Accelerometer will improve 2 primary outcomes and 2 secondary outcomes in patients with Hypotension, Orthostatic. Measurement will happen over the course of 7 days of the treatment or placebo period.

Total standing time measured by an accelerometer
7 DAYS OF THE TREATMENT OR PLACEBO PERIOD
The percentage of total standing time during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs. The accelerometer quantifies the length of time spent in the upright and seated or supine positions.
7 DAYS OF THE TREATMENT OR PLACEBO PERIOD
Total number of steps measured by an accelerometer
7 DAYS OF TREATMENT OR PLACEBO PERIOD
Number of steps during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs
7 DAYS OF TREATMENT OR PLACEBO PERIOD
Orthostatic symptoms
7 DAYS OF TREATMENT OR PLACEBO PERIOD
Orthostatic symptoms measured by the Orthostatic Hypotension Questionnaire (OHQ). The questionnaire is divided into two parts: Part I, Symptom Assessment (OHSA), consisted of six questions, each rating the intensity of one characteristic symptom of OH: 1) Dizziness, lightheadedness, feeling faint, or feeling like you might blackout; 2) Blurring, seeing spots or tunnel vision; 3) Generalized weakness; 4) Fatigue; 5) Trouble concentrating; 6) Head/neck discomfort; and Part II, Daily Activity Scale (OHDAS), consisted of four questions that assessed the impact of neurogenic OH symptoms on daily activities. The recall period is ''over the past week''. The items are scored on an 11-point scale from 0 to 10, with 0 indicating no symptoms/no interference and 10 indicating the worst possible symptoms/complete interference, and the option of selecting ''cannot be done for other reasons''. The composite OHQ score is calculated by averaging the OHSAS and the OHDAS.
7 DAYS OF TREATMENT OR PLACEBO PERIOD
Total walking time measured by an accelerometer
7 DAYS OF TREATMENT OR PLACEBO PERIOD
Total walking time during the treatment or placebo period will be measured by an accelerometer (Activpal) placed on one of the patient's thighs. The accelerometer quantifies the length of time spent walking, standing still, and sitting or lying down.
7 DAYS OF TREATMENT OR PLACEBO PERIOD

Who is running the study

Principal Investigator
I. B.
Prof. Italo Biaggioni, Professor of Medicine and Pharmacology
Vanderbilt University Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is hypotension, orthostatic?

These patients have a high premedication rate when they undergo surgery - perhaps because of the difficulty in estimating haemodynamic stability - and hence a higher incidence of postoperative hypotension, orthostatic hypotension, and post-operative dyspnoea, which could adversely affect post-operative morbidity and may be life-threatening.

Anonymous Patient Answer

Can hypotension, orthostatic be cured?

A significant decrease in SBP and DBP occurs in patients with postoperative hypotension in the PACU. Hypotension can occur in patients after surgical operation at a low blood pressure level, and this may relate to the increased sympathetic activity and decreased the threshold of blood vessels. A correction of blood pressure is required in patients with hypotension to prevent cerebral hypoxia and the deterioration of neurological function in the intensive care unit.

Anonymous Patient Answer

What are the signs of hypotension, orthostatic?

The signs of orthostatic hypotension are the typical presentation of both orthostatic hypotension (OH) and postural orthostatic tachycardia syndrome (POTS). The most common symptoms of OH are headache and presyncope. Some clinical studies suggest that OH may be considered as a differential diagnosis in some patients presenting with syncope or presyncope. The diagnosis should be confirmed by testing the blood pressure in both standing and reclining positions. Postural tachycardia syndrome (POTS) is diagnosed based on symptoms and objective signs and should be differentiated from other causes of orthostatic hypotension and syncope, including OH and vasovagal.

Anonymous Patient Answer

How many people get hypotension, orthostatic a year in the United States?

In a large cohort of the National Health and Nutrition Examination Survey population, 1 of every 2 US adults reported hypotension, orthostatic symptoms, or both in 2008-2009. Recent findings were generally consistent with the incidence of hypotension, orthostatic symptoms, or their combination that was reported in the National CVD (cardiovascular disease) risk assessment, which utilized the same NHANES methodology as the current exercise test.

Anonymous Patient Answer

What are common treatments for hypotension, orthostatic?

Orthostatic hypotension is a common cause of syncope and has a high prevalence. However, we cannot find a common treatment for it. It is necessary to determine whether orthostatic hypotension is primary or secondary.

Anonymous Patient Answer

What causes hypotension, orthostatic?

Orthostatic hypotension is common and typically presents with dizziness, lightheadedness, nausea and vomiting, headache, or palpitations. The most common medical cause of hypotension, however, is from drug interaction rather than from hypotension itself. There is strong evidence for the association between migraine and headache.

Anonymous Patient Answer

Have there been any new discoveries for treating hypotension, orthostatic?

In recent decades, no significant breakthroughs have been made for treating hypotension or orthostatic intolerance. However, a number of drugs are effective and potentially safe, and they must be carefully evaluated for each patient to determine which agent will help the patient the most.

Anonymous Patient Answer

Have there been other clinical trials involving accelerometer?

Data from a recent study was the first to demonstrate the benefits of using an accelerometer to detect the changes in body position before and after exercise in pediatric patients.

Anonymous Patient Answer

How serious can hypotension, orthostatic be?

Hypotension (systolic BP < 90 mmHg) or orthostatic hypotension (< 100 mmHg) has an extremely low risk of serious sequelae with a few exceptions, particularly those with a history of myocardial infarction, severe hypertension, and/or diabetes mellitus and with severe hypotension (< 70 mmHg) of 30 minutes' duration.

Anonymous Patient Answer

Is accelerometer typically used in combination with any other treatments?

The accelerometer was used as an additional aid in the management of hypotension in patients treated with medications to prevent orthostatic hypotension, and was very useful for patients who were unwilling or unable to take medication.

Anonymous Patient Answer

Does hypotension, orthostatic run in families?

Hypotension, orthostatic hypotension, is an inherited condition affecting 1-2 per 50,000 in the general population. Inheritance is often due to a single recessive gene and a single mutation in the same gene. This can be inherited from one person to other. In these families hypotension, orthostatic hypotension is also often present at a higher frequency than in the general population. However, hypotension, orthostatic hypotension is not inevitable but it is a marker for more serious disorders.

Anonymous Patient Answer

What is the latest research for hypotension, orthostatic?

Many [questions remain unanswered about the effectiveness of orthostatic blood pressure control|orthostatic blood pressure control] in terms of preventing cardiovascular complications like ischemic heart disease, cerebrovascular accident, and stroke. Clinical trials for orthostatic blood pressure control appear to be limited in size and scope, but [information about orthostatic blood pressure control is available through the U.S. National Institutes of Health (https://www.ncbi.nlm.nih.gov)] Clinical protocols also exist. All research is needed since orthostatic hypotension can lead to serious cardiovascular complications, even when patients are treated appropriately.

Anonymous Patient Answer
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