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Spanish Atrial Fibrillation And Resynchronization Study (SPAREIII)

This study is not yet open for participant recruitment.
Verified August 2010 by Hospital Clinic of Barcelona
Sponsor:
Collaborators:
University of Navarrra Hospital (Clinica Universitaria)
Fundación para la Investigación del Hospital Clínico de Valencia
Puerta de Hierro University Hospital
Hospital Universitario Ramon y Cajal
Hospital Universitario La Fe
Hospital Universitario La Paz
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01181414
First received: August 2, 2010
Last updated: August 16, 2010
Last verified: August 2010
History of Changes
  Purpose

The aim of the present study is to compare the response to cardiac resynchronization therapy (CRT) in patients with chronic advanced heart failure and permanent atrial fibrillation (AF) depending on atrio ventricular junction (AVJ) is ablated or not.


Condition Intervention Phase
Chronic Heart Failure
Cardiomyopathy, Dilated
Atrial Fibrillation
 Procedure: Atrio ventricular junction ablation with radio-frequency
Drug: Beta blocker/digoxine/amiodarone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
    Comparison of echocardiographic responders in patients with permanent atrial fibrillation submitted to cardiac resynchronization therapy depending on whether the atrio-ventricular junction is ablated or not. Echocardiographic response was defined as left ventricular end-systolic volume reduction >10%.


Secondary Outcome Measures:
  • Clinical response to Cardiac resynchronization therapy. [ Time Frame: 1-year follow-up ] [ Designated as safety issue: No ]
    Comparison of clinical response in patients with permanent atrial fibrillation submitted to cardiac resynchronization therapy, depending on whether the atrio-ventricular junction has been ablated or not. Clinical response is defined as not death/heart transplantation and improvement of the distance walked in the 6-minute walking test >10%.


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atrioventricular junction ablation
Atrioventricular junction ablation by using radiofrequency energy.
 Procedure: Atrio ventricular junction ablation with radio-frequency
Atrioventricular junction ablation by using radiofrequency energy.
Active Comparator: Drug control of ventricular rate
Drug control of ventricular rate.
 Drug: Beta blocker/digoxine/amiodarone
Ventricular rate control by using drug treatment.
Other Name: Negative chronotropic drugs pharmacological treatment .

Detailed Description:

Cardiac resynchronization therapy (CRT) improves the functional capacity and the quality of life and reduces the mortality of patients with dilated cardiomyopathy, low ejection fraction and wide QRS.

Only 2% of patients included in CRT randomized trials were in AF.

To obtain a good response to CRT, percentage >90% of ventricular pacing must be obtained.

Based on observational studies, current guidelines of CRT recommend the atrio ventricular junction (AVJ) ablation in those patients with permanent atrial fibrillation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dilated cardiomyopathy (LVEDD >56 mm)
  • wide QRS (> 120 msec)
  • NYHA III-IV
  • EF<35%
  • Permanent AF
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181414

Contacts
Contact: José M Tolosana, M.D. 0034 93 2275551 ext 2795 tolosana@clinic.ub.es

Sponsors and Collaborators
Hospital Clinic of Barcelona
University of Navarrra Hospital (Clinica Universitaria)
Fundación para la Investigación del Hospital Clínico de Valencia
Puerta de Hierro University Hospital
Hospital Universitario Ramon y Cajal
Hospital Universitario La Fe
Hospital Universitario La Paz
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Investigators
Principal Investigator: Jose M Tolosana, M.D. Hospital Clinic, University of Barcelona
  More Information

No publications provided

Responsible Party: Dr. José M Tolosana, Hospital Clinic, University of Barcelona
ClinicalTrials.gov Identifier: NCT01181414     History of Changes
Other Study ID Numbers: SPARE III - 2010
Study First Received: August 2, 2010
Last Updated: August 16, 2010
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:
Permanent Atrial Fibrillation
Resynchronization therapy
Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Cardiomyopathy, Dilated
Heart Failure
Cardiomyopathies
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiomegaly
Adrenergic beta-Antagonists
Amiodarone
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Enzyme Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on May 19, 2013