Atrial FlutterPhase 2NCT00616629

Cardiac Electrophysiological Study

A Phase 2 study testing AZD1305 in people with Atrial Flutter, run by AstraZeneca at 13 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Atrial Flutter
What is being tested?: AZD1305
Type of treatment: Injection or infusion
How many people: 55 participants
Where: 13 sitesin 4 countries
Study dates: Jan 2008to Jun 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with atrial flutter (with a ventricular rate of <100 beats/minute at enrolment), scheduled for curative catheter ablation
Sinus rhythm at randomisation

Who cannot join

QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
QRS duration >120 ms at randomisation

Trial locations and contacts

13 sites in 4 countries.

Country

City, postcode or hospital

13 sites in 4 countries

Denmark4 sites

Research Site
Aalborg
Research Site
Aarhus
Research Site
Copenhagen
Research Site
Hellerup

Other trials in Denmark

Sweden4 sites

Research Site
Gŏteborg
Research Site
Linkŏping
Research Site
Ŏrebro
Research Site
Umeå

Other trials in Sweden

Finland3 sites

Research Site
Helsinki
Research Site
Kuopio
Research Site
Oulu

Other trials in Finland

Norway2 sites

Research Site
Bergen
Research Site
Oslo

Other trials in Norway

About this study

Official title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Singledose, Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness and Haemodynamics of an Intravenous Infusion of AZD1305 in Patients Undergoing an Invasive Electrophysiological Procedure

The purpose of the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures

Conditions: Atrial Flutter
Being tested: AZD1305
Medical subject headings: Atrial Flutter

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD1305Drug
Intravenous infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))
Absolute change, after - before infusion
Measured: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product

Secondary outcomes (6)

RAERP (Right Atrial Effective Refractory Period)
Absolute change, after - before infusion
Measured: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product
VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)
Absolute change, after - before infusion
Measured: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product
QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia' Formula =QT/RR1/3 Interval in Seconds)
Absolute change, after - before infusion
Measured: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona
Cmax Observed for AZD1305
A total of 13 scheduled PK samples for each patient during and after infusion
Measured: During and after infusion
AUC Total of AZD1305 (Umol*h/L)
A total of 13 scheduled PK samples for each patient during and after infusion
Measured: Based on PK samples during and after infusion
Number of Patients Who Had at Least One AE
Number of patients
Measured: During active treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jun 2008

First posted15 Feb 2008 (estimated)
Study startJan 2008
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FlutterStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00616629
Sponsor's protocol ID: D3190C00005
Other IDs: 2007-0003455-36 (EudraCT No)
Status last verified: Aug 2011
First submitted: 5 Feb 2008
Last updated: 22 Sep 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
Recruiting
Atrial Flutter Ablation in the iCMR
Atrial Flutter Typical

All Atrial Flutter trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Singledose, Phase II Study to Assess the Effects on Atrial and Ventricular Refractoriness and Haemodynamics of an Intravenous Infusion of AZD1305 in Patients Undergoing an Invasive Electrophysiological Procedure
ClinicalTrials.gov ID: NCT00616629
Acronym / sponsor ID: D3190C00005
Conditions: Atrial Flutter
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 15 Feb 2008 (estimated)
Results: Posted 22 Sep 2011

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 the study is to measure the effects of AZD1305 on cardiac electrophysiological properties and intracardiac pressures

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Double blind (participant, investigator)

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with atrial flutter (with a ventricular rate of <100 beats/minute at enrolment), scheduled for curative catheter ablation
Sinus rhythm at randomisation

Key exclusion criteria (3 listed)

QTc (Fridericia, QTcF ) >450 ms measured in sinus rhythm at randomisation,
Serum potassium below 3.8 or above 5.0 mmol/L or plasma potassium below 3.6 or above 5.0 mmol/L
QRS duration >120 ms at randomisation

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
AZD1305Intravenous infusion	Drug	–

Primary outcome

LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))
Time frame: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product
Absolute change, after - before infusion

6 secondary outcomes

RAERP (Right Atrial Effective Refractory Period)
Time frame: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product
VERP (Ventricular Effective Refractory Period)) and Other Electrophysiological and Electrocardiographic Variables; RR, P Wave Duration, PR, QRS, QTend, QTcF, QTtop, QTend - QTtop)
Time frame: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product
QTcF (Interval From the Beginning of the Q or R Wave to the End of the T Wave in the Surface ECG, Corrected for Changes in RR Interval Using Fridericia' Formula =QT/RR1/3 Interval in Seconds)
Time frame: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. ECG measurements, including QTcF, are available from several additiona
Cmax Observed for AZD1305
Time frame: During and after infusion
AUC Total of AZD1305 (Umol*h/L)
Time frame: Based on PK samples during and after infusion
Number of Patients Who Had at Least One AE
Time frame: During active treatment period

Results and safety

Results posted to the registry on 22 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AZD1305 Dose Group 1	13	11
AZD1305 Dose Group 2	14	12
AZD1305 Dose Group 3	14	13
AZD1305 Dose Group 4	2	2
Placebo	12	12

Primary outcome: LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation))

Time frame: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product. Mean (Full Range). Unit: ms

Measure	AZD1305 Dose Group 1 n = 11	AZD1305 Dose Group 2 n = 11	AZD1305 Dose Group 3 n = 13	AZD1305 Dose Group 4 n = 2	Placebo n = 11
Value	11 (-15)	43 (0)	55 (-5)	50 (40)	-10 (-90)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD1305 Dose Group 1	0 of 11 (0%)	2 of ?	Not reported
AZD1305 Dose Group 2	1 of 12 (8.3%)	1 of ?	Not reported
AZD1305 Dose Group 3	1 of 13 (7.7%)	1 of ?	Not reported
AZD1305 Dose Group 4	0 of 2 (0%)	1 of ?	Not reported
Placebo	1 of 12 (8.3%)	0 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Flutter

RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
Recruiting
Atrial Flutter Ablation in the iCMR
Atrial Flutter Typical

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.

Lauri Toivonen, MD principal investigator

Helsinki University Central Hospital

13 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1305 in people with Atrial Flutter, run by AstraZeneca at 13 sites in 4 countries.

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 2 inclusion and 3 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: finished, as of the sponsor's last update on 22 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Denmark, Sweden, Finland, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Yes. Results are posted in the registry (first posted 22 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

LAERP (Left Atrial Effective Refractory Period (ie, the Longest S1-S2 Interval That Fails to Result in Atrial Depolarisation)) (time frame: Measurements were obtained twice, from the invasive electrophysiological measurements made before and 20 min (or more) after the start of administration of the investigational product). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00616629.

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 22 Sep 2011.