Multiple Interventions for Orthostatic Intolerance
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test various treatments for orthostatic intolerance, a condition where standing up significantly increases heart rate and can cause dizziness or fainting. Researchers are testing different medications and methods, such as acetazolamide (a diuretic) and melatonin, to determine which best controls these symptoms. Individuals who have experienced these issues for more than six months might be suitable for the trial. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those taking drugs that could worsen fast heart rates. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that some medications tested in this trial have different safety profiles.
Research has found that Acetazolamide can cause sensitivity to sunlight and skin redness. It is generally well-tolerated, but some people may feel dizzy when standing due to a drop in blood pressure.
Atomoxetine has been found safe for short-term use in managing certain blood pressure issues, although it may increase heart rate and symptoms in some cases.
Clonidine is generally safe, but it can cause mild dizziness when standing. People with a history of low blood pressure should use it carefully.
Entacapone might increase the chance of dizziness when taken with other drugs like levodopa.
Indomethacin has not been fully studied for safety in this context, but it may raise blood pressure when used with certain other medications.
Isosorbide Dinitrate often causes headaches and dizziness, especially when standing, due to its effects on blood pressure.
Mecamylamine is used for treating high blood pressure, but it is not suitable for everyone, especially those with heart issues.
Memantine is typically safe, but some users have reported heart-related issues, including dizziness when standing.
Melatonin may worsen symptoms of dizziness in some cases.
Midodrine is used to treat low blood pressure, but it can cause high blood pressure when lying down.
Modafinil is generally well-tolerated and does not significantly affect heart rate in patients with similar conditions.
Octreotide has been used safely in patients with difficult-to-treat dizziness, though detailed safety data is limited.
Propranolol is a beta-blocker that has been used safely, but it may cause allergic reactions in some people.
Sertraline, an antidepressant, is considered safe and well-tolerated, although it has a small risk of causing dizziness when standing.
The abdominal binder has been shown to be effective and safe in improving symptoms when standing.
Participants should discuss any concerns with healthcare providers before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for orthostatic intolerance because they explore a wide array of mechanisms and approaches, offering potential breakthroughs in managing this challenging condition. Unlike the standard treatments such as fludrocortisone and beta-blockers, which mainly focus on stabilizing blood pressure, these investigational treatments target different pathways. For example, Modafinil, typically used for narcolepsy, may enhance wakefulness and counteract fatigue. Midodrine works by constricting blood vessels to increase blood pressure. Meanwhile, Melatonin, more commonly known for regulating sleep, may offer benefits by influencing the nervous system. This diversity in therapeutic strategies could lead to more personalized and effective treatment options for patients.
What evidence suggests that this trial's treatments could be effective for orthostatic intolerance?
This trial studies various treatments for managing orthostatic intolerance, a condition where standing causes an excessive increase in heart rate. Atomoxetine has effectively reduced symptoms and stabilized blood pressure in similar conditions. Clonidine lowered heart rate and reduced symptoms by affecting the nervous system's response. Midodrine and propranolol have shown improvements in reducing dizziness and maintaining a steady heart rate. Octreotide helped control blood pressure when standing. While melatonin reduced heart rate spikes, it did not improve overall symptoms. These treatments offer several options for symptom relief by addressing orthostatic intolerance in different ways.23678
Who Is on the Research Team?
Satish R Raj, MD MSCI
Principal Investigator
Vanderbilt University School of Medicine
Are You a Good Fit for This Trial?
This trial is for people who've felt dizzy or had a rapid heartbeat when standing up, lasting more than 6 months. It's not suitable for those with severe conditions like cancer or heart disease, or if they're taking drugs that could make their symptoms worse.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various mechanistically unique medications to control heart rate and improve symptoms of orthostatic intolerance
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abdominal binder
- Acetazolamide
- Atomoxetine
- Breathing Device
- Clonidine
- Drinking Water
- Entacapone
- Indomethacin
- Isosorbide Dinitrate
- IV Saline
- Mecamylamine
- Melatonin
- Memantine
- Midodrine
- Modafinil
- Octreotide
- Placebo
- Propranolol
- Sertraline
Trial Overview
The study tests various treatments including medications like Octreotide and Propranolol, lifestyle aids such as abdominal binders, and other approaches to manage rapid heartbeat and discomfort upon standing in patients with orthostatic intolerance.
How Is the Trial Designed?
20
Treatment groups
Experimental Treatment
Placebo Group
Abdominal binder with inflatable pressure over abdomen
Memantine
Mecamylamine
Isosorbide Dinitrate
Indomethacin
Entacapone
Clonidine
NO Drug
Atomoxetine
Dead Space Breathing Device
Drinking Water
Normal Saline (0.9%) 1 liter
Sertraline
Propranolol
Octreotide
Modafinil
Midodrine
Melatonin
Acetazolamide
Placebo (lactose tablet)
Acetazolamide is already approved in United States, European Union, Canada for the following indications:
- Glaucoma
- Epilepsy
- Edema
- Altitude sickness
- Glaucoma
- Epilepsy
- Edema
- Glaucoma
- Epilepsy
- Edema
- Altitude sickness
Find a Clinic Near You
Who Is Running the Clinical Trial?
Satish R. Raj
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
National Center for Advancing Translational Sciences (NCATS)
Collaborator
Citations
Effects of Patient-Controlled Abdominal Compression on ...
Outcome measures The effect of abdominal binding prior to rising on orthostatic symptoms was measured as the difference in Orthostatic Symptom Scale scores ...
Automated Abdominal Binder for Orthostatic Hypotension | ...
The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these patients.
Elastic Abdominal Binders Attenuate Orthostatic ...
In conclusion, abdominal binders are an effective tool in reducing OH on tilt‐table testing (class I evidence). Moreover, our data provide class III evidence ...
A Safety-Centric Study on the Use of Inflatable Abdominal ...
The results showed that the use of an elastic abdominal binder was associated with improved orthostatic tolerance in PD patients with OH. A ...
Abdominal Compression as a Treatment for Postural ...
This study provides evidence that abdominal compression may be an effective treatment for POTS, especially when used in combination with a β‐blocker.
A Safety-Centric Study on the Use of Inflatable Abdominal ...
The results showed that the use of an elastic abdominal binder was associated with improved orthostatic tolerance in PD patients with OH. A ...
7.
researchgate.net
researchgate.net/publication/383554376_A_Safety-Centric_Study_on_the_Use_of_Inflatable_Abdominal_Binders_for_Managing_Orthostatic_HypotensionA Safety-Centric Study on the Use of Inflatable Abdominal ...
Contrary to this, the study found that to maintain safe external pressure on the abdomen, the binder should not be inflated over 25 mmHg. This ...
Compression Garment Reduces Orthostatic Tachycardia ...
Recently, a study that used an inflatable abdominal binder in adults with POTS demonstrated an improvement in systolic blood pressure (SBP) when standing, but ...
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