Chronic Heart FailurePhase 4SPAREIIINCT01181414
Spanish Atrial Fibrillation And Resynchronization Study
A Phase 4 study testing Atrio ventricular junction ablation with radio-frequency and Beta blocker/digoxine/amiodarone in people with Chronic Heart Failure and Cardiomyopathy, Dilated, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Cardiomyopathy, Dilated, Atrial Fibrillation
- What is being tested?
- Atrio ventricular junction ablation with radio-frequency and Beta blocker/digoxine/amiodarone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2010to Jan 2015
- 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
- Dilated cardiomyopathy (LVEDD >56 mm)
- wide QRS (> 120 msec)
- NYHA III-IV
- EF<35%
- Permanent AF
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.
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.
Read the 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.
- Being tested
- Atrio ventricular junction ablation with radio-frequency, Beta blocker/digoxine/amiodarone
- Keywords
- Permanent Atrial Fibrillation, Resynchronization therapy, Ablation
- Medical subject headings
- Cardiomyopathy, Dilated, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrio ventricular junction ablation with radio-frequencyProcedure or surgery
Atrioventricular junction ablation by using radiofrequency energy.
Beta blocker/digoxine/amiodaroneDrug
Also called Negative chronotropic drugs pharmacological treatment .
Ventricular rate control by using drug treatment.
| Study group | Role | What they receive |
|---|---|---|
| Atrioventricular junction ablation | Experimental | Atrioventricular junction ablation by using radiofrequency energy. Receives: Procedure: Atrio ventricular junction ablation with radio-frequency |
| Drug control of ventricular rate | Active comparator | Drug control of ventricular rate. Receives: Drug: Beta blocker/digoxine/amiodarone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.
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%.
Measured: 1-year follow-up
Secondary outcomes (1)
Clinical response to Cardiac resynchronization therapy.
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%.
Measured: 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
- Investigators
- Jose M Tolosana, M.D., Principal investigator, Hospital Clinic, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181414
- Sponsor's protocol ID
- SPARE III - 2010
- Acronym
- SPAREIII
- Status last verified
- Mar 2015
- First submitted
- 2 Aug 2010
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4. Study of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT01181414
- Acronym / sponsor ID
- SPAREIII / SPARE III - 2010
- Keywords
- Permanent Atrial Fibrillation, Resynchronization therapy, Ablation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- 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
- Study start
- Oct 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrioventricular junction ablation | Experimental | Procedure: Atrio ventricular junction ablation with radio-frequencyAtrioventricular junction ablation by using radiofrequency energy. |
| Drug control of ventricular rate | Active comparator | Drug: Beta blocker/digoxine/amiodaroneDrug control of ventricular rate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Dilated cardiomyopathy (LVEDD >56 mm)
- wide QRS (> 120 msec)
- NYHA III-IV
- EF<35%
- Permanent AF
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Atrio ventricular junction ablation with radio-frequencyAtrioventricular junction ablation by using radiofrequency energy. | Procedure or surgery | Atrioventricular junction ablation |
| Beta blocker/digoxine/amiodaroneAlso: Negative chronotropic drugs pharmacological treatment .Ventricular rate control by using drug treatment. | Drug | Drug control of ventricular rate |
Primary outcome
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation.
Time frame: 1-year follow-up
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%.
1 secondary outcome
Clinical response to Cardiac resynchronization therapy.
Time frame: 1-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Jose M Tolosana, M.D. principal investigator
Hospital Clinic, University of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atrio ventricular junction ablation with radio-frequency and Beta blocker/digoxine/amiodarone in people with Chronic Heart Failure and Cardiomyopathy, Dilated, run by Hospital Clinic of Barcelona at 1 site 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 10 Mar 2015. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Left ventricular reverse remodelling in cardiac resynchronization therapy and atrial fibrillation. (time frame: 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2015.