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Ventricular TachycardiaPhase 4NCT00383799

Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia

A Phase 4 study testing iv Amiodarone and iv Procainamide in people with Ventricular Tachycardia and Wide QRS Tachycardia, run by Hospital General Universitario Gregorio Marañon at 29 sites in Spain.

Terminated

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

Official record
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Trial summary

The purpose of this study is to determine whether intravenous amiodarone has less cardiac significant adverse events compared to intravenous procainamide in the acute treatment of haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably ventricular origen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventricular Tachycardia, Wide QRS Tachycardia
What is being tested?
iv Amiodarone and iv Procainamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
302 participants
Where
29 sitesSpain
Study dates
Sep 2005to Jun 2011
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with stable tachycardia ≥120 lpm, QRS ≥120 ms and haemodynamically well tolerated defined as: 1)Systolic blood pressure ≥90 mmHg, 2) absence of dyspnea at rest, 3)absence of peripheric hypoperfusion signs and 4)no severe angina.
  • Age > 18 years
  • Written inform consent obtained

Who cannot join

  • Treatment with iv amiodarone or iv procainamide during the previous 24 hours
  • QRS tachycardia <120 ms
  • Patients with QRS ≥120 ms tachycardia with haemodynamic compromise that requires urgent cardioversion for termination
  • Irregular tachycardia
  • Tachycardia that is considered as supraventricular due to physician criteria (adenosine and/or vagal manoeuvres response)
  • Patient that do not want to cooperate

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Spain29 sites

  • Hospital General

    Alicante

  • Hospital Clinic

    Barcelona

  • Hospital Vall d'Hebron

    Barcelona

  • Hospital de Basurto

    Bilbao

  • Hospital Santa María del Rosell

    Cartagena, Murcia

  • Fundación Hospitalaria de Cieza

    Cieza, Murcia

  • Hospital El Escorial

    El Escorial, Madrid

  • Hospital Universitario de Getafe

    Getafe, Madrid

  • Hospital San Cecilio

    Granada

  • Hospital Virgen de las Nieves

    Granada

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital 12 de Octubre

    Madrid

  • Hospital Clínico San Carlos

    Madrid

  • Hospital de La Princesa

    Madrid

  • Hospital de Móstoles

    Madrid

  • Hospital General Universitario La Paz

    Madrid

  • Hospital Puerta de Hierro

    Madrid

  • Hospital Carlos Haya

    Málaga

  • Hospital Clínico Virgen de la Victoria

    Málaga

  • Hospital Virgen de la Arrixaca

    Murcia

  • Hospital de Son Dureta

    Palma de Mallorca

  • Hospital de Son Llatzer

    Palma de Mallorca

  • Hospital Los Arcos

    San Javier, Murcia

  • Hospital de Donostia

    San Sebastián

  • Hospital de Valme

    Seville

  • Hospital Universitario Virgen del Rocío

    Seville

  • Hospital Virgen de la Salud

    Toledo

  • Hopital Clínico Universitario

    Valencia

  • Hospital Río Hortega

    Valladolid

Other trials in Spain

About this study

Official title: Comparison of Intravenous Amiodarone Versus Intravenous Procainamide for the Acute Treatment of Regular and Haemodynamically Well Tolerated Wide QRS Tachycardia (Probably of Ventricular Origen). The PROCAMIO Multicenter Study

The purpose of this study is to determine whether intravenous amiodarone has less cardiac significant adverse events compared to intravenous procainamide in the acute treatment of haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably ventricular origen.

Read the detailed description

Multicenter, prospective and randomized study in phase IV. A total of 302 patients will be included in the study within 40-50 institutions in Spain. Patients with regular and monomorphic tachycardia ≥ 120 bpm, QRS ≥ 120 ms and haemodynamically well tolerated will be randomized to receive iv amiodarone (single dosage: 5 mg/kg in 20 minutes) vs iv procainamide (single dosage: 10 mg/kg in 20 minutes). The study period will be 40 minutes from infusion initiation. Study variables include the presence of clinically cardiac significant adverse events: hypotension, syncope, heart failure, symptomatic sinus bradycardia, AV block, proarrhythmia and tachycardia acceleration (<20 lpm)and death. Total observation period will be 24 hours after the end of the infusion.

Being tested
iv Amiodarone, iv Procainamide
Keywords
Ventricular tachycardia
Medical subject headings
Tachycardia, Ventricular

What participants receive

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

  • iv AmiodaroneDrug

  • iv ProcainamideDrug

Study groups in NCT00383799
Study groupRoleWhat they receive
Group 1Active comparatorIV procainamide (single dose: 10 mg/kg over 20 min)
Receives: Drug: iv Procainamide
Group 2Active comparatorIV Amiodarone (single dose: 5 mg/kg over 20 min)
Receives: Drug: iv Amiodarone

What is being measured

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

  1. To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation

    Measured: 40 minutes

Secondary outcomes (2)

  1. To compare efficacy of both therapies in relation to episode termination

    Measured: 40 minuutes

  2. To compare the rate of total adverse events, cardiac and non cardiac, occurring during an observation period of 24 hours after treatment was applied

    Measured: 24 hours

Timeline

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

  1. First posted4 Oct 2006 (estimated)
  2. Study startSep 2005
  3. Primary completionJun 2011
  4. Study completionJun 2011

Why it stopped: Steering Committee decision after inclusion of 74 patients after 6 years and very slow inclusion rate

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00383799
Sponsor's protocol ID
2005-001505-25
Other IDs
2005
Status last verified
Mar 2016
First submitted
3 Oct 2006
Last updated
6 Apr 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 6: advanced cardiovascular life support: section 5: pharmacology I: agents for arrhythmias. The American Heart Association in collaboration with the International Liaison Committee on Resuscitation. Circulation. 2000 Aug 22;102(8 Suppl):I112-28. No abstract available.

    PubMed 10966669

  • ECC Committee, Subcommittees and Task Forces of the American Heart Association. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2005 Dec 13;112(24 Suppl):IV1-203. doi: 10.1161/CIRCULATIONAHA.105.166550. Epub 2005 Nov 28. No abstract available.

    PubMed 16314375

  • Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B, Blanc JJ, Budaj A, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (writing committee to develop Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Sep 5;114(10):e385-484. doi: 10.1161/CIRCULATIONAHA.106.178233. Epub 2006 Aug 25. No abstract available.

    PubMed 16935995

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing iv Amiodarone and iv Procainamide in people with Ventricular Tachycardia and Wide QRS Tachycardia, run by Hospital General Universitario Gregorio Marañon at 29 sites in Spain.

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 3 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: stopped early, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Steering Committee decision after inclusion of 74 patients after 6 years and very slow inclusion rate). 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?

To compare clinically significant cardiac adverse events occurring within 40 minutes from treatment initiation (time frame: 40 minutes). 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 NCT00383799, which also lists 3 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 6 Apr 2016.

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