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ArrhythmiasAAD and CRTNCT02575534

Acute Mechanical Response to Anti-arrhythmic Drug Therapy

A study testing Procainamide in people with Arrhythmias, run by Evan Adelstein, MD at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The aim of this study is to determine if anti-arrhythmic drugs with a sodium channel-blocking mechanism exert a detrimental electromechanical effect on cardiac function in patients depending upon baseline intraventricular conduction and left ventricular function. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Arrhythmias
What is being tested?
Procainamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Oct 2015to 27 Feb 2018
Phase
Interventional
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 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Implanted cardiac device requiring generator change and a new device
  • Able to give informed consent

Who cannot join

  • Current membrane-active anti-arrhythmic
  • Glomerular filtration rate (GRF)<30 milliliters (mL)/min
  • MAP<60 mmHg
  • Known intolerance to procainamide
  • Pregnancy
  • Age <18 or >85 years old
  • Baseline QT interval >480 ms (500 ms if paced)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Evan Adelstein

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

The aim of this study is to determine if anti-arrhythmic drugs with a sodium channel-blocking mechanism exert a detrimental electromechanical effect on cardiac function in patients depending upon baseline intraventricular conduction and left ventricular function.

Read the detailed description

Amiodarone therapy is used frequently for control of ventricular arrhythmias in patients who receive painful shocks from an implantable cardioverter-defibrillator (ICD). Data in post-myocardial infarction (MI) patients and ICD patients suggest that amiodarone is mortality-neutral; it neither confers increased nor decreased mortality. However, these data are derived from patients largely with normal intraventricular conduction, manifesting as a QRS complex duration on the surface ECG <120 ms. Amiodarone, in addition to potassium-channel blocking effects, is a sodium channel-blocker. Because sodium channels mediate cardiac depolarization, and a QRS complex >120 ms is indicative of abnormal depolarization, amiodarone may not be benign in patients with such conduction defects. Patients with cardiac resynchronization therapy-defibrillators (CRT-D), who all have abnormal baseline intraventricular conduction, may therefore be adversely affected by amiodarone. Anecdotal clinical data suggest that this may be the case, but the question of amiodarone's cardiac safety profile in CRT patients has never been studied.

Conditions
Arrhythmias
Being tested
Procainamide
Keywords
anti-arrhythmic therapy
Medical subject headings
Arrhythmias, Cardiac

What participants receive

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

  • ProcainamideDrug

    Also called procan

    the procainamide will be infused at 12mcg/kg up to a max of 1 gram at a rate of 20mg/min which will take up to 1 hour to infuse

Study groups in NCT02575534
Study groupRoleWhat they receive
observationalExperimentalAll patients will undergo 12-lead ECG and transthoracic echocardiography on the day of the study. These studies will be performed on patients as their previously implanted device is reprogrammed to pace in different modes. Patients will then receive an infusion of procainamide (12 mg/kg up to a maximum of 1 g) at a rate of 20 mg/min. Repeat ECG and echocardiograms will then be performed. The patient's device will be programmed to a specific setting before and after the procainamide infusion.
Receives: Drug: Procainamide

What is being measured

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

  1. Change in QRS duration

    the QRS waveform measurements will be calculated on the EKG prior to and after the procainamide infusion

    Measured: baseline and 1 hour post infusion

  2. changes in left ventricular volumes as measured via echocardiogram

    the left ventricular volume will be calculated via echocardiogram pre and post procainamide infusion

    Measured: baseline and 1 hour post infusion

  3. changes in ejection fraction as measured via echocardiogram

    ejection fraction will be calculated via echocardiogram pre and post procainamide infusion.

    Measured: baseline and 1hour post infusion

  4. changes in RV-LV electrical activation (in CRT patients)

    The RV-LV electrical activation will be assessed during the device interrogation pre and post procainamide infusion.

    Measured: baseline and 1 hour post infusion

Timeline

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

  1. First posted14 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion27 Feb 2018
  4. Study completion27 Feb 2018

Why it stopped: No enrollment in study.

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02575534
Sponsor's protocol ID
PRO14010486
Acronym
AAD and CRT
Status last verified
Jun 2018
First submitted
16 Jun 2015
Last updated
28 Jun 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum A, Blomstrom P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacretaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbuchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsanyi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14.

    PubMed 22082198

  • Packer DL, Prutkin JM, Hellkamp AS, Mitchell LB, Bernstein RC, Wood F, Boehmer JP, Carlson MD, Frantz RP, McNulty SE, Rogers JG, Anderson J, Johnson GW, Walsh MN, Poole JE, Mark DB, Lee KL, Bardy GH. Impact of implantable cardioverter-defibrillator, amiodarone, and placebo on the mode of death in stable patients with heart failure: analysis from the sudden cardiac death in heart failure trial. Circulation. 2009 Dec 1;120(22):2170-6. doi: 10.1161/CIRCULATIONAHA.109.853689. Epub 2009 Nov 16.

    PubMed 19917887

  • Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L, Greene HL, et al. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. N Engl J Med. 1991 Mar 21;324(12):781-8. doi: 10.1056/NEJM199103213241201.

    PubMed 1900101

  • Cardiac Arrhythmia Suppression Trial II Investigators. Effect of the antiarrhythmic agent moricizine on survival after myocardial infarction. N Engl J Med. 1992 Jul 23;327(4):227-33. doi: 10.1056/NEJM199207233270403.

    PubMed 1377359

  • Cairns JA, Connolly SJ, Roberts R, Gent M. Randomised trial of outcome after myocardial infarction in patients with frequent or repetitive ventricular premature depolarisations: CAMIAT. Canadian Amiodarone Myocardial Infarction Arrhythmia Trial Investigators. Lancet. 1997 Mar 8;349(9053):675-82. doi: 10.1016/s0140-6736(96)08171-8.

    PubMed 9078198

  • Julian DG, Camm AJ, Frangin G, Janse MJ, Munoz A, Schwartz PJ, Simon P. Randomised trial of effect of amiodarone on mortality in patients with left-ventricular dysfunction after recent myocardial infarction: EMIAT. European Myocardial Infarct Amiodarone Trial Investigators. Lancet. 1997 Mar 8;349(9053):667-74. doi: 10.1016/s0140-6736(96)09145-3.

    PubMed 9078197

  • Connolly SJ, Dorian P, Roberts RS, Gent M, Bailin S, Fain ES, Thorpe K, Champagne J, Talajic M, Coutu B, Gronefeld GC, Hohnloser SH; Optimal Pharmacological Therapy in Cardioverter Defibrillator Patients (OPTIC) Investigators. Comparison of beta-blockers, amiodarone plus beta-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators: the OPTIC Study: a randomized trial. JAMA. 2006 Jan 11;295(2):165-71. doi: 10.1001/jama.295.2.165.

    PubMed 16403928

Questions about this trial

What is this clinical trial studying?

A study testing Procainamide in people with Arrhythmias, run by Evan Adelstein, MD 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 7 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: withdrawn, as of the sponsor's last update on 28 Jun 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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 QRS duration (time frame: baseline and 1 hour post infusion). The study lists 4 primary outcomes in all. 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 NCT02575534, which also lists 7 linked publications.

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 28 Jun 2018.

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