Effect of Ivabradine on Patients With Postural Orthostatic Tachycardia Syndrome
Condition: Postural Orthostatic Tachycardia Syndrome
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Intervention: Ivabradine; Placebo
Intervention description: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.; A substance that has no therapeutic effect and will act as a control.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 20 patients with POTS will receive Ivabradine treatment vs placebo for one month. Then there will be a one-month wash out period prior to the cross over in which patients who received Ivabradine will receive the placebo, and patients who initially were on placebo will now receive Ivabradine.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: POTS; tachycardia; ivabradine

Summary:

      Postural orthostatic tachycardia syndrome (POTS) occurs in approximately 500,000 Americans,
      but predominates in women with a 5:1 ratio. Patients with POTS experience debilitating
      tachycardia upon postural changes such as standing that impairs their quality of life.
      Tachycardia is clinically defined as a heart rate greater than 100 beats/min; and in POTS
      patients, the prolonged heart rate increase is greater than 30 beats/min or increases to 120
      beats/min within the first ten minutes of a diagnostic tilt table test without postural
      hypotension. There are currently no effective treatment methods for POTS. However, several
      studies suggest Ivabradine could be a main treatment option for POTS because Ivabradine
      specifically inhibits the f-channels (If) within the sinoatrial (SA) node, which slows the
      heart rate. Currently in the US, Ivabradine is mainly prescribed to treat chronic heart
      failure. It is well tolerated in patients, but it is not commonly prescribed for POTS. It has
      been also used for treatment of inappropriate sinus tachycardia with good benefit. The
      hypothesis for this experiment is that Ivabradine will reduce tachycardia and improve
      functional status in patients with POTS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18-65.

          -  Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE> 600pg/ml))

          -  Subjects with no structural heart disease

          -  Subject with no arrhythmias

          -  Subjects with norepinephrine levels greater than 600 pg/ml

          -  Subjects with normal CBC, Metabolic, and thyroid levels

        Exclusion Criteria:

          -  Thyroid or adrenal disorders

          -  Drugs that interfere with Ivabradine (example: Cytochrome P450 drugs)

          -  Presentation of peripheral edema and discolored toes with peripheral autonomic
             neuropathy. Symptoms include: legs (reduced hair growth, cramps), toes (blue color),
             legs/feet (wounds, ulcers that do not heal), and muscles (numbness, heaviness)

          -  Subjects who have had a history of systemic illnesses (acute or chronic infectious);
             autoimmune/ inflammatory disease, cancer, COPD, anemia, diabetes, or psychiatric
             illness

          -  Subjects with resting heart rate< 60beats/min, atrial fibrillation, advanced AV
             blocks, sinus disease, and acute decompensated heart failure and severe hepatic
             impairment.

          -  Smokers or alcohol abuse

          -  Pregnant or breastfeeding mothers

          -  Woman of childbearing potential who are unwilling to use highly effective
             contraception during treatment and for an additional one month after discontinuing the
             study drug