1- Primary (Sarcomeric) Hypertrophic CardiomyopathyREEF-CMHNCT01729702
Neurohormonal Parameters in Hypertrophic Cardiomyopathies
A study testing blood sample collection in people with 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy and 2- Obstructive Hypertrophic Cardiomyopathy, run by French Cardiology Society at 1 site in France.
Trial summary
The primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy, 2- Obstructive Hypertrophic Cardiomyopathy, 3- Non Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- blood sample collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Dec 2013
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Age 18 to 75 years
- Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with studies of exercise peak oxygen consumption and cardiac MRI with gadolinium late-enhancement
- Informed consent
- Patient with a social insurance Patient at rest
- - Age 18 to 75 years
- Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive
- Informed consent
- Patient with a social insurance
Who cannot join
- - Insufficient echogenicity
- Permanent atrial fibrillation
- Complete BBB on the ECG
- LVEF < 35 %
- Previous septal ablation (surgical or percutaneous)
- Simultaneous participation to another biomedical research
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- If exercise needed:
- contraindication to exercise : hemodynamic instability, uncontrolled high blood pressure (>220/120 mmHg), severe aortic stenosis
- Inability to exercise (muscular, pulmonary, elderly patient)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies
The primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)
Read the detailed description
The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and their relationships with extent of MRI myocardial fibrosis with the degree of exercise functional limitation.
- Conditions
- 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy, 2- Obstructive Hypertrophic Cardiomyopathy, 3- Non Obstructive Hypertrophic Cardiomyopathy
- Being tested
- blood sample collection
- Keywords
- 1- Hypertrophic cardiomyopathy, 2- BNP, 3- NT-proBNP, 4- Neurohormons
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample collectionOther
| Study group | Role | What they receive |
|---|---|---|
| single group - consecutive patients | Other | Not described Receives: Other: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine
Measured: Day 1 at rest and during exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startApr 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 1- Primary (Sarcomeric) Hypertrophic CardiomyopathyStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albert Hagège, MD-PhD, Study chair, HEGP - Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729702
- Sponsor's protocol ID
- 2008-08
- Acronym
- REEF-CMH
- Status last verified
- Mar 2014
- First submitted
- 15 Nov 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation at Rest and Exercise of Clinical, Ultrasonic and Neurohormonal Parameters in Hypertrophic Cardiomyopathies
- ClinicalTrials.gov ID
- NCT01729702
- Acronym / sponsor ID
- REEF-CMH / 2008-08
- Conditions
- 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy, 2- Obstructive Hypertrophic Cardiomyopathy, 3- Non Obstructive Hypertrophic Cardiomyopathy
- Keywords
- 1- Hypertrophic cardiomyopathy, 2- BNP, 3- NT-proBNP, 4- Neurohormons
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Nov 2012 (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 primary purpose of this study is to demonstrate that changes in plasma levels of circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)
Detailed description
The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and their relationships with extent of MRI myocardial fibrosis with the degree of exercise functional limitation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group - consecutive patients | Other | Other: blood sample collection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- - Age 18 to 75 years
- Primary (sarcomeric) hypertrophic cardiomyopathy, obstructive or non obstructive, with studies of exercise peak oxygen consumption and cardiac MRI with gadolinium late-enhancement
- Informed consent
- Patient with a social insurance Patient at rest
- - Age 18 to 75 years
Key exclusion criteria (9 listed)
- - Insufficient echogenicity
- Permanent atrial fibrillation
- Complete BBB on the ECG
- LVEF < 35 %
- Previous septal ablation (surgical or percutaneous)
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 |
|---|---|---|
| blood sample collection | Other | single group - consecutive patients |
Primary outcome
Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine
Time frame: Day 1 at rest and during exercise
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 26 Mar 2014.
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.
Albert Hagège, MD-PhD study chair
HEGP - Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample collection in people with 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy and 2- Obstructive Hypertrophic Cardiomyopathy, run by French Cardiology Society at 1 site in France.
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 8 inclusion and 9 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 26 Mar 2014. 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 France. 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.
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?
Plasmatic Neurohormonal measures: BNP - NT ProBNP - Troponine (time frame: Day 1 at rest and during exercise). 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 26 Mar 2014.