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Carbonic Anhydrase Inhibitor
Multiple Interventions for Orthostatic Intolerance
Phase 1 & 2
Waitlist Available
Led By Satish R Raj, MD MSCI
Research Sponsored by Satish R. Raj
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Obvious cause of hypovolemia or drugs that could worsen tachycardia
Chronic severe medical conditions such as cancer or ischemic heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Summary
This trial is testing different medications to see which one is best at controlling heart rate and improving symptoms of orthostatic intolerance.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects from the treatments may include digestive changes, blood pressure fluctuations, sleep disturbances with melatonin, headache or dizziness from Midodrine, fatigue from Modafinil, and skin reactions at injection sites.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking any medication that could worsen a fast heartbeat.
Select...
I have a long-term serious illness like cancer or heart disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
20Treatment groups
Experimental Treatment
Placebo Group
Group I: Abdominal BinderExperimental Treatment1 Intervention
Abdominal binder with inflatable pressure over abdomen
Group II: 9Experimental Treatment1 Intervention
Memantine
Group III: 8Experimental Treatment1 Intervention
Mecamylamine
Group IV: 7Experimental Treatment1 Intervention
Isosorbide Dinitrate
Group V: 6Experimental Treatment1 Intervention
Indomethacin
Group VI: 5Experimental Treatment2 Interventions
Entacapone
Group VII: 4Experimental Treatment1 Intervention
Clonidine
Group VIII: 3Experimental Treatment1 Intervention
NO Drug
Group IX: 2Experimental Treatment2 Interventions
Atomoxetine
Group X: 19Experimental Treatment1 Intervention
Dead Space Breathing Device
Group XI: 18Experimental Treatment1 Intervention
Drinking Water
Group XII: 17Experimental Treatment1 Intervention
Normal Saline (0.9%) 1 liter
Group XIII: 16Experimental Treatment1 Intervention
Sertraline
Group XIV: 15Experimental Treatment4 Interventions
Propranolol
Group XV: 13Experimental Treatment1 Intervention
Octreotide
Group XVI: 12Experimental Treatment2 Interventions
Modafinil
Group XVII: 11Experimental Treatment1 Intervention
Midodrine
Group XVIII: 10Experimental Treatment1 Intervention
Melatonin
Group XIX: 1Experimental Treatment1 Intervention
Acetazolamide
Group XX: 14Placebo Group1 Intervention
Placebo (lactose tablet)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150
Modafinil
FDA approved
Octreotide
FDA approved
Propranolol
FDA approved
Memantine
FDA approved
Abdominal binder
2010
N/A
~120
Midodrine
FDA approved
Acetazolamide
FDA approved
Atomoxetine
FDA approved
Clonidine
FDA approved
Entacapone
FDA approved
Indomethacin
FDA approved
Mecamylamine
FDA approved
Isosorbide dinitrate
FDA approved
Sertraline
FDA approved
IV Saline
2016
Completed Phase 4
~180
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,812 Previous Clinical Trials
8,161,321 Total Patients Enrolled
Satish R. RajLead Sponsor
6 Previous Clinical Trials
540 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
363 Previous Clinical Trials
412,354 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any medication that could worsen a fast heartbeat.I have a long-term serious illness like cancer or heart disease.I have had symptoms for over 6 months when standing up.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
- Group 3: 3
- Group 4: 4
- Group 5: 5
- Group 6: 6
- Group 7: 7
- Group 8: 8
- Group 9: 9
- Group 10: 10
- Group 11: 11
- Group 12: 12
- Group 13: 13
- Group 14: 14
- Group 15: 15
- Group 16: 16
- Group 17: 17
- Group 18: 18
- Group 19: 19
- Group 20: Abdominal Binder
Awards:
This trial has 2 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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