Postural Tachycardia SyndromePhase 2NCT01761825
The Effect of Ivabradine on Patients With Postural Tachycardia Syndrome
A Phase 2 study testing ivabradine in people with Postural Tachycardia Syndrome, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Postural Tachycardia Syndrome
- What is being tested?
- ivabradine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Feb 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
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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.
About this study
Official title: The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.
The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.
- Conditions
- Postural Tachycardia Syndrome
- Being tested
- ivabradine
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivabradineDrug
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Active comparator | Ivabradine 10 mg once Receives: Drug: ivabradine |
| placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in heart rate after the administration of Ivabradine
Measured: 60 minutes , during the whole trial
the change in blood pressure after the administration of Ivabradine
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761825
- Sponsor's protocol ID
- TASMC-12-JG-547-CTIL
- Status last verified
- Jan 2013
- First submitted
- 17 Nov 2012
- Last updated
- 7 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of "Funny" Channel Blocker Ivabradine on Patients With Postural Tachycardia Syndrome.
- ClinicalTrials.gov ID
- NCT01761825
- Acronym / sponsor ID
- TASMC-12-JG-547-CTIL
- Conditions
- Postural Tachycardia Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (estimated)
- First posted
- 7 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Ivabradine is an effective treatment for postural tachycardia syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Active comparator | Drug: ivabradineIvabradine 10 mg once |
| placebo | Placebo comparator | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed with POTS by the following criteria:
Key exclusion criteria (6 listed)
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ivabradine | Drug | Ivabradine |
Primary outcome
the change in heart rate after the administration of Ivabradine
Time frame: 60 minutes , during the whole trial
the change in blood pressure after the administration of Ivabradine
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ivabradine in people with Postural Tachycardia Syndrome, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in heart rate after the administration of Ivabradine (time frame: 60 minutes , during the whole trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.