Ventricular Premature ComplexesPhase 2NCT01833455

Premature Ventricular Contractions (PVCs) and Blood Pressure Control

A Phase 2 study testing PVC Suppression using Flecainide in people with Ventricular Premature Complexes and Blood Pressure, run by University of Wisconsin, Madison at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

The purpose of this study is to determine if reduction in premature ventricular contraction (PVC) burden results in a decrease in blood pressure, sympathetic outflow, plasma catecholamines and an improvement in baroreflex gain. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Ventricular Premature Complexes, Blood Pressure
What is being tested?: PVC Suppression using Flecainide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Jun 2016
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Frequent symptomatic premature ventricular contractions (PVCs) (>10% of total QRSs on a 24-hour Holter)
Willingness to participate in research

Who cannot join

Age > 65 years old
Pacemaker implantation
Implantable cardioverter defibrillator implantation requiring pacing
Sick sinus syndrome
Atrio-ventricular (AV) block
Left ventricular dysfunction defined as left ventricular ejection fraction < 50%

Show all 14Show fewer

History of myocardial infarction or coronary artery disease
Severe left ventricular hypertrophy (wall thickness > 1.5 cm by echocardiography performed within 3 months from enrollment)
Severe liver dysfunction
Creatinine clearance of 35 mL/min/1.73 square meters or less
Pregnancy
Known hypersensitivity to the drug
QRS duration > 120 ms
Recent change in blood pressure medication within 30 days of enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs

Conditions: Ventricular Premature Complexes, Blood Pressure
Being tested: PVC Suppression using Flecainide, No PVC Suppression using Placebo
Medical subject headings: Ventricular Premature Complexes

What participants receive

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

PVC Suppression using FlecainideDrug
Also called Tambocor
Flecainide will be administered to result in a reduction in PVC burden.
No PVC Suppression using PlaceboDrug
Placebo (sugar pills) will be given to result in no alteration in PVC burden.

Study groups in NCT01833455
Study group	Role	What they receive
PVC Suppression then Placebo	Placebo comparator	This arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days. Receives: Drug: PVC Suppression using Flecainide; Drug: No PVC Suppression using Placebo
Placebo then PVC Suppression	Placebo comparator	This arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days. Receives: Drug: PVC Suppression using Flecainide; Drug: No PVC Suppression using Placebo

What is being measured

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

Change in Mean Arterial Pressure
Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.
Measured: Baseline and 28 days

Secondary outcomes (1)

Change in Muscle Sympathetic Nerve Activity
Muscle sympathetic nerve activity was measured as number of bursts of neural activity per 100 heart beats.
Measured: Baseline and 28 days

Timeline

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

Feb 2013Jun 2016

First posted16 Apr 2013 (estimated)
Study startFeb 2013
Primary completionJun 2016
Study completionJun 2016

Why it stopped: Insufficient enrollment.

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 Ventricular Premature ComplexesStudies of the same condition, open and under way.
More trials run by University of Wisconsin, MadisonThe 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01833455
Sponsor's protocol ID: UW-PVC-2012-0510
Status last verified: Jan 2019
First submitted: 9 Apr 2013
Last updated: 22 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruitingObservational study
Premature Ventricular Complex and Diet Inflamatuar Index
Premature Ventricular Complexes, Diet Quality
Recruiting
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)

All Ventricular Premature Complexes trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of PVC Suppression on Blood Pressure Control in Patients With Frequent PVCs
ClinicalTrials.gov ID: NCT01833455
Acronym / sponsor ID: UW-PVC-2012-0510
Conditions: Ventricular Premature Complexes, Blood Pressure
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Insufficient enrollment.
Enrolment: 8 participants (actual)
Lead sponsor: University of Wisconsin, MadisonUniversity, hospital or other
Study start: Feb 2013
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 16 Apr 2013 (estimated)
Results: Posted 22 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PVC Suppression then Placebo	Placebo comparator	Drug: PVC Suppression using Flecainide, Drug: No PVC Suppression using PlaceboThis arm will undergo attempted PVC suppression using flecainide for 28 days and then undergo no PVC suppression using placebo for 28 days.
Placebo then PVC Suppression	Placebo comparator	Drug: PVC Suppression using Flecainide, Drug: No PVC Suppression using PlaceboThis arm will undergo no PVC suppression using placebo for 28 days and then undergo attempted PVC suppression using flecainide for 28 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Frequent symptomatic premature ventricular contractions (PVCs) (>10% of total QRSs on a 24-hour Holter)
Willingness to participate in research

Key exclusion criteria (14 listed)

Age > 65 years old
Pacemaker implantation
Implantable cardioverter defibrillator implantation requiring pacing
Sick sinus syndrome
Atrio-ventricular (AV) block

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
PVC Suppression using FlecainideAlso: TambocorFlecainide will be administered to result in a reduction in PVC burden.	Drug	PVC Suppression then Placebo, Placebo then PVC Suppression
No PVC Suppression using PlaceboPlacebo (sugar pills) will be given to result in no alteration in PVC burden.	Drug	PVC Suppression then Placebo, Placebo then PVC Suppression

Primary outcome

Change in Mean Arterial Pressure
Time frame: Baseline and 28 days
Mean arterial blood pressure was calculated from non-invasive systolic and diastolic arm measurements.

1 secondary outcome

Change in Muscle Sympathetic Nerve Activity
Time frame: Baseline and 28 days

Results and safety

Results posted to the registry on 22 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PVC Suppression Then Placebo	4	3
Placebo Then PVC Suppression	4	4

Primary outcome: Change in Mean Arterial Pressure

Time frame: Baseline and 28 days. Mean (Standard Deviation). Unit: mmHg

Measure	Change From Base 1 to PVC Suppression n = 3	Change From Base 2 to no PVC Suppression n = 3	Change From Base 1 to no PVC Suppression n = 4	Change From Base 2 to PVC Suppression n = 4
Value	2 (2)	1 (4)	3 (11)	-4 (8)

Population analysed: Mean arterial blood pressure values were not available at all time points for every patient. Data on subjects who completed the study is presented here and may not reflect changes seen in a larger population.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Base 1 to PVC Suppression	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Base 2 to no PVC Suppression	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Base 1 to no PVC Suppression	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Base 2 to PVC Suppression	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): This study was terminated prematurely due to a loss of staff available to make the technical measurements involved. The small number of data points available lead us to conclude the data is uninterpretable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Ventricular Premature Complexes

RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Not yet recruitingObservational study
Premature Ventricular Complex and Diet Inflamatuar Index
Premature Ventricular Complexes, Diet Quality
Recruiting
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)

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.

Mohamed H Hamdan, MD, MBA principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PVC Suppression using Flecainide in people with Ventricular Premature Complexes and Blood Pressure, run by University of Wisconsin, Madison at 1 site in United States.

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 14 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: stopped early, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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. 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?

Yes. Results are posted in the registry (first posted 22 Feb 2019). 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?

Change in Mean Arterial Pressure (time frame: Baseline and 28 days). 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 NCT01833455.

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 Feb 2019.