Hypertrophic Obstructive Cardiomyopathy (HOCM)Phase 2CARDIO-HCMNCT01332162
CArdiac Desynchronization In Obstructive HCM, CARDIO-HCM
A Phase 2 study testing Biventricular pacing and No Pacing in people with Hypertrophic Obstructive Cardiomyopathy (HOCM), run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Obstructive Cardiomyopathy (HOCM)
- What is being tested?
- Biventricular pacing and No Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2013to Dec 2020
- Phase
- Phase 2
- 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 hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms
Who cannot join
- HOCM intraventricular gradient < 50mmHg
- LV ejection fraction < 50%
- mild symptoms
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Dr. Josep Brugada, MD. PhD., +34932275703, jbrugada@clinic.ub.es
Dr.Antonio Berruezo, MD. PhD., +34 93 2275551, aberruezo@clinic.ub.es
About this study
Official title: CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy
The purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.
Read the detailed description
In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.
- Being tested
- Biventricular pacing, No Pacing
- Keywords
- Hypertrophic Obstructive Cardiomyopathy (HOCM), Pacing
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biventricular pacingDevice
Also called CRT-D and CRT-P devices:, Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical, Promote Q CD3221-36. St. Jude Medical, Pacemaquer:
All patients will be pacing during two years
No PacingDevice
Also called CRT-D and CRT-P devices:, Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical, Promote Q CD3221-36. St. Jude Medical, Pacemaquer:
No Pacing during the first year. In the second year all patients will be pacing
| Study group | Role | What they receive |
|---|---|---|
| Biventricular pacing | Experimental | All patients will be pacing during two years Receives: Device: Biventricular pacing |
| No Pacing during the first year | Active comparator | No Pacing during the first year. In the second year all patients will be pacing Receives: Device: No Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)
Measured: 1 and 2 years
Secondary outcomes (1)
Change from Baseline in Clinical evaluation of NYHA,QoL,6MWT,interventricular septum thickness,posterior wall thickness,provoked left ventricular outflow tract gradient,mitral regurgitation grade.
Change from Baseline in Clinical evaluation (New York Heart Association(NYHA), Quality of life Questionnaire (QoL), 6 Minutes Walk Test (6MWT)), interventricular septum thickness, posterior wall thickness, provoked left ventricular outflow tract gradient, mitral regurgitation grade.
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJun 2013
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Obstructive Cardiomyopathy (HOCM)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Brugada, Hospital Clinic of Barcelona
- Investigators
- JOSEP BRUGADA, MD, PhD, Principal investigator, Hospital Clinic of BarcelonaANTONIO BERRUEZO, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01332162
- Sponsor's protocol ID
- CRT-01-2011-HCPB
- Acronym
- CARDIO-HCM
- Status last verified
- Oct 2016
- First submitted
- 1 Apr 2011
- Last updated
- 20 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CArdiac Desynchronization In Obstructive Hypertrophic CardioMyopathy
- ClinicalTrials.gov ID
- NCT01332162
- Acronym / sponsor ID
- CARDIO-HCM / CRT-01-2011-HCPB
- Keywords
- Hypertrophic Obstructive Cardiomyopathy (HOCM), Pacing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Apr 2011 (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 purpose of this study is to evaluate the benefit of the optimal pacing configuration, including the possibility of biventricular or left ventricular pacing, in hypertrophic obstructive cardiomyopathy patients.
Detailed description
In this study, subjects will be randomized to Cardiac Resynchronization Therapy-Defibrillation (CRT-D) or Cardiac Resynchronization Therapy-Pacing (CRT-P) vs Pacing Therapy AAI. Randomization will be stratified by indication. Optimal pharmacological therapy in both treatment arms. Length of follow-up for each subject will be 2y, since all subjects will be followed to a common study termination date.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biventricular pacing | Experimental | Device: Biventricular pacingAll patients will be pacing during two years |
| No Pacing during the first year | Active comparator | Device: No PacingNo Pacing during the first year. In the second year all patients will be pacing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with hypertrophic Obstructive Cardiomyopathy with significant left ventricular obstruction (baseline LVOT gradient more 50mmHg and severe symptoms
Key exclusion criteria (3 listed)
- HOCM intraventricular gradient < 50mmHg
- LV ejection fraction < 50%
- mild symptoms
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 |
|---|---|---|
| Biventricular pacingAlso: CRT-D and CRT-P devices:, Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical, Promote Q CD3221-36. St. Jude Medical, Pacemaquer:All patients will be pacing during two years | Device | Biventricular pacing |
| No PacingAlso: CRT-D and CRT-P devices:, Promote Quadra CD3239-40, CD3239-40Q. St. Jude Medical, Promote Q CD3221-36. St. Jude Medical, Pacemaquer:No Pacing during the first year. In the second year all patients will be pacing | Device | No Pacing during the first year |
Primary outcome
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg).
Time frame: 1 and 2 years
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg)
1 secondary outcome
Change from Baseline in Clinical evaluation of NYHA,QoL,6MWT,interventricular septum thickness,posterior wall thickness,provoked left ventricular outflow tract gradient,mitral regurgitation grade.
Time frame: 1 and 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2016.
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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.
JOSEP BRUGADA, MD, PhD principal investigator
Hospital Clinic of Barcelona
ANTONIO BERRUEZO, MD principal investigator
Hospital Clinic 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 2 study testing Biventricular pacing and No Pacing in people with Hypertrophic Obstructive Cardiomyopathy (HOCM), 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Oct 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Left ventricular mass and resting left ventricular outflow tract gradient (mmHg). (time frame: 1 and 2 years). 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 20 Oct 2016.