The Effect of Ivabradine on Patients With Postural Tachyc... | NCT01761825

Studies
The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome

NCT01761825

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Unknown status

Last Update Posted

Jan 7, 2013Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Postural Tachycardia Syndrome

Interventions

ivabradine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Feb 2013Estimated

Completion Date

Not provided

First Submitted Date

Nov 17, 2012

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2013

Last Update Posted Date

Jan 7, 2013Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Ivabradine	Active Comparator	Ivabradine 10 mg once	Drug: ivabradine
placebo	Placebo Comparator

Name	Type	Description	Arm Group Labels	Other Names
ivabradine	Drug		Ivabradine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with POTS by the following criteria:
1. The presence of characteristic orthostatic symptoms of the POTS for at least six months.
2. 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.
3. No other concomitant diseases that could explain the symptoms of POTS.
  
  Exclusion Criteria:
1. History of systemic illness capable of affecting of affecting autonomic function (eg, diabetes mellitus, SLE).
2. History of cardiovascular disease.
3. History of smoking, drug or alcohol abuse.
4. Pregnancy, and also uncontrolled thyroid or adrenal disorders.
5. Using any drug metabolized by cytochrome P450 3A4 enzyme during the last 72 hours.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054972	Postural Orthostatic Tachycardia Syndrome

Ancestor Terms

ID	Term
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077550	Ivabradine

Ancestor Terms

ID	Term
D001552	Benzazepines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided