NCT01761825

Brief Summary

The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 7, 2013

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

January 7, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

November 17, 2012

Last Update Submit

January 3, 2013

Conditions

Postural Tachycardia Syndrome

Outcome Measures

Primary Outcomes (2)

  • the change in heart rate after the administration of Ivabradine

    60 minutes , during the whole trial

  • the change in blood pressure after the administration of Ivabradine

    60 minutes

Study Arms (2)

Ivabradine

ACTIVE COMPARATOR

Ivabradine 10 mg once

Drug: ivabradine

placebo

PLACEBO COMPARATOR

Interventions

ivabradineDRUG
Ivabradine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients diagnosed with POTS by the following criteria:
  • The presence of characteristic orthostatic symptoms of the POTS for at least six months.
  • An increase in the heart rate of at least 30 beats per minute (without concomitant significant decrease in blood pressure of more than 20/10 mmHg) within 10 minutes after assuming a standing position (or during tilt test) on at least 3 separate occasions.
  • No other concomitant diseases that could explain the symptoms of POTS.

You may not qualify if:

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  • History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE).
  • History of cardiovascular disease.
  • History of smoking, drug or alcohol abuse.
  • Pregnancy, and also uncontrolled thyroid or adrenal disorders.
  • Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2012

First Posted

January 7, 2013

Study Start

December 1, 2012

Primary Completion

February 1, 2013

Last Updated

January 7, 2013

Record last verified: 2013-01