Drug Effects for Postural Orthostatic Tachycardia Syndrome

Overseen By Bonnie K Black, BSN CNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Satish R. Raj

Disqualifiers: Inability to give consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

260 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What safety data exists for the treatment of Postural Orthostatic Tachycardia Syndrome?

The research articles provided do not contain specific safety data for the treatment of Postural Orthostatic Tachycardia Syndrome under the names DAXOR, Intrinsic Heart Rate, or QSweat. ^{1 2 3 4 5}

How does the drug differ from other treatments for postural orthostatic tachycardia syndrome?

This drug is unique because it specifically targets the heart's pacemaker activity to reduce heart rate, unlike other treatments that may not focus on this mechanism. ^{2 3 4 6 7}

What is the purpose of this trial?

The purpose of this study is to describe the mechanism of orthostatic intolerance, relying on cardiovascular physiological studies. The syndrome is of undetermined etiology, but the syndrome causes impairment of a number of young adults, females more than males, with symptoms of tachycardia, fatigue, lightheadedness, palpitations, blurred vision, chest discomfort, difficulty concentrating, and dizziness with the upright posture. It is believed that many different pathophysiological processes can give rise to this disorder.

Research Team

David Robertson, M.D.

Principal Investigator

Vanderbilt University

Eligibility Criteria

This trial is for young adults, especially females, who experience rapid heartbeat, fatigue, lightheadedness, and other symptoms when standing up (Orthostatic Intolerance). Participants must be able to give informed consent.

Inclusion Criteria

I feel dizzy or faint when standing up.

Exclusion Criteria

Inability or unwillingness to give informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cardiovascular Physiological Studies

Participants undergo cardiovascular physiological studies to describe the mechanism of orthostatic intolerance

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after the physiological studies

4 weeks

Treatment Details

Interventions

• DAXOR
• Intrinsic Heart Rate
• QSweat

Trial Overview The study aims to understand the causes of Orthostatic Intolerance by using cardiovascular physiological tests like DAXOR for blood volume measurement, QSweat for sweat production analysis, and checking intrinsic heart rate.

Participant Groups

Group I: Patients Experimental Treatment 3 Interventions

Patients with orthostatic intolerance

Group II: Healthy Control Subjects Experimental Treatment 3 Interventions

Healthy subjects to determine "normal" response

Who Is Running the Clinical Trial?

Satish R. Raj

Lead Sponsor

Trials

7

Recruited

690+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study involving 54 patients with POTS, low-dose propranolol (20 mg) significantly reduced heart rates and improved symptoms compared to placebo, indicating its efficacy as a treatment option.

Higher doses of propranolol (80 mg) resulted in greater reductions in heart rate but did not provide additional symptom relief and may have worsened symptoms, suggesting that lower doses may be more beneficial for managing POTS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. Raj, SR., Black, BK., Biaggioni, I., et al.[2021]

In a study of 708 patients with postural orthostatic tachycardia syndrome, various medications were found to effectively manage symptoms, with success rates of 52.2% for light-headedness and 53.4% for pain.

The study highlighted that while insomnia treatment was more effective in females, other symptom therapies showed no gender differences, indicating that medications can be tailored to individual symptoms for better management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilisation of medications to reduce symptoms in children with postural orthostatic tachycardia syndrome. Boris, JR., Bernadzikowski, T.[2019]

Postural orthostatic tachycardia syndrome (POTS) is a common cause of dizziness in young people, often misdiagnosed as anxiety due to its symptoms, which can lead to years of undiagnosed issues.

The paper discusses various treatment strategies for POTS, including both conservative and pharmacologic approaches, while also exploring the condition's complex cardiovascular mechanisms and the physiological basis of heart rate variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postural Orthostatic Tachycardia Syndrome Misdiagnosed as Anxiety: A Case Report with a Review of Therapy and Pathophysiology. Kesserwani, H.[2020]

In a study of 27 children with postural orthostatic tachycardia syndrome, ivabradine led to symptom improvement in 67% of patients, particularly reducing syncope/presyncope by 90%.

Ivabradine significantly lowered heart rates in both sitting and standing positions without causing significant changes in blood pressure, although some patients experienced mild side effects like visual disturbances and bradycardia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ivabradine in children with postural orthostatic tachycardia syndrome: a retrospective study. Towheed, A., Nesheiwat, Z., Mangi, MA., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Baroreflex sensitivity predicts therapeutic effects of metoprolol on pediatric postural orthostatic tachycardia syndrome. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Propranolol decreases tachycardia and improves symptoms in the postural tachycardia syndrome: less is more. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Utilisation of medications to reduce symptoms in children with postural orthostatic tachycardia syndrome. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Postural Orthostatic Tachycardia Syndrome Misdiagnosed as Anxiety: A Case Report with a Review of Therapy and Pathophysiology. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Low-dose propranolol and exercise capacity in postural tachycardia syndrome: a randomized study. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Hemodynamic profile and heart rate variability in hyperadrenergic versus non-hyperadrenergic postural orthostatic tachycardia syndrome. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Ivabradine in children with postural orthostatic tachycardia syndrome: a retrospective study. [2021]