NCT02575534

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 14, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2018

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

2.4 years

First QC Date

June 16, 2015

Last Update Submit

June 26, 2018

Conditions

Arrhythmias

Keywords

anti-arrhythmic therapy

Outcome Measures

Primary Outcomes (4)

  • Change in QRS duration

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

    baseline and 1 hour post infusion

  • changes in left ventricular volumes as measured via echocardiogram

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

    baseline and 1 hour post infusion

  • changes in ejection fraction as measured via echocardiogram

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

    baseline and 1hour post infusion

  • 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.

    baseline and 1 hour post infusion

Study Arms (1)

observational

EXPERIMENTAL

All 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.

Drug: Procainamide

Interventions

ProcainamideDRUG

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

Also known as: procan
observational

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evan Adelstein

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (7)

  • 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.

    PMID: 22082198RESULT

  • 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.

    PMID: 19917887RESULT

  • 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.

    PMID: 1900101RESULT

  • 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.

    PMID: 1377359RESULT

  • 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.

    PMID: 9078198RESULT

  • 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.

    PMID: 9078197RESULT

  • 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.

    PMID: 16403928RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Procainamide

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic Chemicalspara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Evan Adelstein, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Evan Adelstein, MD

Study Record Dates

First Submitted

June 16, 2015

First Posted

October 14, 2015

Study Start

October 1, 2015

Primary Completion

February 27, 2018

Study Completion

February 27, 2018

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

US(1)