Heart FailurePhase 2/3AUGMENT-HFNCT01311791
A Randomized, Controlled Study to Evaluate Algisyl-LVR™ as a Method of Left Ventricular Augmentation for Heart Failure
A Phase 2/3 study testing Algisyl-LVR and Standard medical therapy in people with Heart Failure and Dilated Cardiomyopathy, run by LoneStar Heart, Inc. at 18 sites in 6 countries.
Trial summary
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Heart Failure, Dilated Cardiomyopathy
- What is being tested?
- Algisyl-LVR and Standard medical therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 18 sitesin 6 countries
- Study dates
- Aug 2012to May 2016
- Phase
- Phase 2/3
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients must be able and willing to give written informed consent
- The patients will be adult (age ≥ 18 years and ≤ 79 years) males or females
- The patients must be on stable, evidence-based therapy for heart failure
- Note: CRT or CRT-D are acceptable co-therapy, if placed > 3 months before randomization or the investigator does not anticipate within 6 months after randomization
- The patients will have a left ventricular ejection fraction equal to or less than 35% via echocardiography, cardiac catheterization, radionuclide scan, or magnetic resonance imaging (measured within the last 30 days)
- The patients will have a left ventricular end diastolic dimension indexed to body surface area (LVEDDi) of 30 to 40mm/m2 (LVEDD/BSA) (measured within the last 30 days)
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- Patients must have symptomatic heart failure with a Peak VO2 of 9.0 - 14.5 ml/min/kg (performed using a bicycle ergometer). Patients must perform two CPX tests (within 30 days of randomization and performed at least 20 hours apart) that differ by no more than 15% in the observed value for Peak VO2 and have a mean value of 9.0 - 14.5 ml/min/kg from these two tests.
- Patient's surgical risk must be considered reasonable and the evaluation of surgical risk should include review of coronary and left ventricular angiography
- If female, the patients must be (a) post-menopausal, (b) surgically sterile, or (c) using adequate birth control and have a negative serum pregnancy test within 7 days prior to administration of study device
Who cannot join
- Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months.
- Patients presenting with cardiogenic shock.
- Patients who have undergone a previous mid-sternotomy surgical procedure are excluded unless the surgeon's assessment is that the left sided limited thoracotomy is feasible and considered reasonable surgical risk.
- Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis
- Patient with a history of constrictive pericarditis
- Patients with a Q wave myocardial infarction (MI) within the last 30 days
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- Patients with a recent history of stroke (within 60 days prior to the surgical procedure)
- A left ventricular (LV) wall thickness of the LV free-wall, at the mid-ventricular level, of less than 8 mm (screening echocardiography must confirm a minimum wall thickness of 8 mm)
- Patients with a serum creatinine > 2.5 mg/dL
- Clinically significant liver enzyme abnormalities, i.e., AST(SGOT) and ALT (SGPT) more than 2.5 times the upper limit of normal
- History of severe COPD (i.e., FEV 1< 1 liter or FEV1 < 50% predicted)
- The patients will not be receiving concurrently an investigational Product in another clinical trial or have received an investigational Product in another clinical trial in the 30 days prior to enrollment
- A life expectancy of less than 1 year or any other condition that, in the opinion of the clinical investigator, might compromise any aspect of the trial
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Italy7 sites
Ospedali riuniti Dipartimento Cardiovascolare
Bergamo, 24128
Istituti Ospitalieri di Cremona
Cremona
Istituto Scientifico Universitario San Raffaele
Milan, 20132
Azienda Ospedaliera di Padova
Padova, 35128
IRCCS San Raffaele Roma
Rome, Rome, 00163
Policlinico Umberto I
Rome, 00161
IRCCS Policlinico San Donato
San Donato, Milanese (MI), 20097
Germany5 sites
Charité (Campus Virchov)
Berlin
Charité - Universitätsmedizin Berlin (Campus Benjamin Franklin)
Berlin
Herzzentrum Dresden Universitätsklinik
Dresden
Universität Schleswig-Holstein Campus Kiel
Kiel
Universitätsklinikum Ulm
Ulm
Romania3 sites
Centrului Clinic de Urgenta de Boli Cardiovasculare al Armatei
Bucharest
Clinica de Cardiologie, Spitalul Clinic de Urgenta "Sf. Pantelimon"
Bucharest
Spitalul Clinic De Urgenta MAI "Prof. Dr. Dimitrie Gerota"
Bucharest
About this study
Official title: A Randomized, Controlled Study to Evaluate the Safety and Cardiovascular Effects of Algisyl-LVR™ as a Method of Left Ventricular Augmentation in Patients With Dilated Cardiomyopathy (AUGMENT-HF)
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Algisyl-LVR™ will be injected into the myocardium under direct visualization during the surgical procedure.
This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV size, restore LV shape, lower LV wall stress and improve global LV function.
Read more
The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake) from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device
The hypothesis of the study is that there is a statistically significant difference in change in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is compared to the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.
Read the detailed description
This is a prospective, randomized, parallel group evaluation of the safety and effectiveness of Algisyl-LVR in patients with dilated cardiomyopathy of either ischemic or non-ischemic origin. The evaluation for primary efficacy endpoint (Peak VO2) at 6 months will be investigator-blinded. The primary safety endpoint, while not blinded, is 30 day all-cause mortality and an objective assessment. The remaining study endpoints will evaluate the effects of the device through the evaluation of functional, structural, biochemical, and electrocardiographic evaluations at 6 and 12 months. Evaluation of adverse events and these assessments will also provide evidence of the safety profile of the device in patients with dilated cardiomyopathy.
Pre-enrollment baseline patient evaluation will include clinical assessment, assessment of New York Heart Association (NYHA) functional class, blood tests, chest x-ray, echocardiography, magnetic resonance imaging (MRI), electrocardiogram, cardiopulmonary exercise testing, submaximal exercise testing, and quality of life assessments. Blinded central evaluation will be performed for measures of cardiopulmonary exercise testing, blood tests, Holter Monitors and cardiac imaging.
After written patient informed consent has been obtained and verification of eligibility, patients who meet the selection criteria will be randomized. All patients must be on stable, evidence-based therapy for heart failure. Patients assigned to the Investigational Device group will have the Algisyl-LVR™ device (implants) administered during a surgical procedure. For patients randomized to the investigational device group, the investigator will make every attempt to minimize the time between randomization and surgery (i.e, no more than 7 to 10 days). Patients will be considered part of the study cohort as soon as they have been randomly allocated to either the Treatment or Control group. This time point will also be considered as the start of follow-up. For patients allocated to the Investigational Device group, the starting point of follow-up for surgical mortality and surgical complications will start as of the date when the surgical procedure is performed (or attempted). The acute response to device implant will be monitored intraoperatively via continuous electrocardiographic cardiac monitoring, arterial pressure lines, transesophageal echocardiography (TEE), and pulmonary artery catheter. Patients receiving the investigational device are expected to remain hospitalized for 5 to 14 days. Patients assigned to the control group will continue on standard medical therapy (without the investigational device).
Follow-up in this study is divided into two phases. During the first phase, referred to as the "efficacy phase", repeat testing of patient functional and cardiac structural parameters will be conducted at follow-up visits scheduled at 3 months and 6 months, and every 6 months thereafter. Follow-up testing will be supplemented by a 30 day (post randomization) telephone contact with all patients. The efficacy phase of the trial will end on a common closing date after a minimum of 6 months of follow-up (i.e., after the last patient enrolled has been completed the 6 month visit). At that point data analysis will be performed and an initial study report will be generated. Following completion of the efficacy phase, long-term monitoring will continue through each patient's 24-month visit. This second phase is referred to as the "extended follow-up phase". During this phase, data collection will be focused on long-term safety and will be conducted at 6-month intervals.
Patient's randomized to the control group and completing the 12 month visit will be provided the option of enrolling in Clinical Study LSH-11-001: An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001. Patients must continue to meet the inclusion and exclusion criteria as stated in Study LSH-10-001 to be eligible for Study LSH-11-001.
- Conditions
- Heart Failure, Dilated Cardiomyopathy
- Being tested
- Algisyl-LVR, Standard medical therapy
- Keywords
- Left ventricular augmentation, Left ventricular restoration
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algisyl-LVRDevice
Also called intramyocardial injections of Alginate hydrogel
Algisyl-LVR™ device (implants) administered during a surgical procedure
Standard medical therapyDrug
Also called evidence-based therapy for heart failure, heart failure medications, drug therapy
as defined per protocol
| Study group | Role | What they receive |
|---|---|---|
| Algisyl-LVR | Experimental | Algisyl-LVR™ device (implants) administered during a surgical procedure. Receives: Device: Algisyl-LVR |
| Standard Medical Therapy | Active comparator | as per protocol Receives: Drug: Standard medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak VO2
The primary effectiveness endpoint will be a comparison of change in Peak VO2 from baseline to 6 months of follow-up between the Algisyl-LVR and medically managed arms with the intention to prove superiority in improvement in Peak VO2 associated with the Algisyl-LVR study group as compared to the medically managed study group. Evaluation of the cardiopulmonary exercise testing will be conducted by a central, blinded core laboratory.
Measured: 6 months
Secondary outcomes (1)
30 day all cause mortality
The primary safety objective is to estimate the 30 day cardiac mortality associated with the implantation of the Algisyl-LVR device and qualitatively compare the observed rate to literature estimates for similar patients undergoing cardiac surgeries comparable in risk to implantation of the Algisyl-LVR
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startAug 2012
- Primary completionApr 2014
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- LoneStar Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurizio Volterani, MD, Principal investigator, IRCCS San Raffaele Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311791
- Sponsor's protocol ID
- LSH-10-001
- Acronym
- AUGMENT-HF
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2011
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anker SD, Coats AJ, Cristian G, Dragomir D, Pusineri E, Piredda M, Bettari L, Dowling R, Volterrani M, Kirwan BA, Filippatos G, Mas JL, Danchin N, Solomon SD, Lee RJ, Ahmann F, Hinson A, Sabbah HN, Mann DL. A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial). Eur Heart J. 2015 Sep 7;36(34):2297-309. doi: 10.1093/eurheartj/ehv259. Epub 2015 Jun 16.
PubMed 26082085Mann DL, Lee RJ, Coats AJ, Neagoe G, Dragomir D, Pusineri E, Piredda M, Bettari L, Kirwan BA, Dowling R, Volterrani M, Solomon SD, Sabbah HN, Hinson A, Anker SD. One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure. Eur J Heart Fail. 2016 Mar;18(3):314-25. doi: 10.1002/ejhf.449. Epub 2015 Nov 11.
PubMed 26555602
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Safety and Cardiovascular Effects of Algisyl-LVR™ as a Method of Left Ventricular Augmentation in Patients With Dilated Cardiomyopathy (AUGMENT-HF)
- ClinicalTrials.gov ID
- NCT01311791
- Acronym / sponsor ID
- AUGMENT-HF / LSH-10-001
- Conditions
- Heart Failure, Dilated Cardiomyopathy
- Keywords
- Left ventricular augmentation, Left ventricular restoration
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- LoneStar Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012 (actual)
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Mar 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.
This is a pilot study to evaluate the safety and efficacy of the Algisyl-LVR™ device. The purpose of this study is to investigate Algisyl-LVR™ employed as a method of left ventricular augmentation and restoration in patients with dilated cardiomyopathy. Algisyl-LVR™ will be injected into the myocardium under direct visualization during the surgical procedure.
This study will evaluate the concept that direct mid left ventricular (LV) intramyocardial injections of Alginate hydrogel implants into the free wall of the failing LV will reduce LV size, restore LV shape, lower LV wall stress and improve global LV function.
The Primary Efficacy Endpoint of the study is the change in Peak VO2 (maximum oxygen uptake) from baseline to 6 months of follow-up. The Primary Safety Endpoint of the study is to estimate the 30 day mortality associated with the implantation of the Algisyl-LVR device
The hypothesis of the study is that there is a statistically significant difference in change in Peak VO2 from baseline to 6 month follow-up when the medically managed arm is compared to the Algisyl-LVR arm, i.e. the Algisyl LVR arm is superior to medical management.
Detailed description
This is a prospective, randomized, parallel group evaluation of the safety and effectiveness of Algisyl-LVR in patients with dilated cardiomyopathy of either ischemic or non-ischemic origin. The evaluation for primary efficacy endpoint (Peak VO2) at 6 months will be investigator-blinded. The primary safety endpoint, while not blinded, is 30 day all-cause mortality and an objective assessment. The remaining study endpoints will evaluate the effects of the device through the evaluation of functional, structural, biochemical, and electrocardiographic evaluations at 6 and 12 months. Evaluation of adverse events and these assessments will also provide evidence of the safety profile of the device in patients with dilated cardiomyopathy.
Pre-enrollment baseline patient evaluation will include clinical assessment, assessment of New York Heart Association (NYHA) functional class, blood tests, chest x-ray, echocardiography, magnetic resonance imaging (MRI), electrocardiogram, cardiopulmonary exercise testing, submaximal exercise testing, and quality of life assessments. Blinded central evaluation will be performed for measures of cardiopulmonary exercise testing, blood tests, Holter Monitors and cardiac imaging.
After written patient informed consent has been obtained and verification of eligibility, patients who meet the selection criteria will be randomized. All patients must be on stable, evidence-based therapy for heart failure. Patients assigned to the Investigational Device group will have the Algisyl-LVR™ device (implants) administered during a surgical procedure. For patients randomized to the investigational device group, the investigator will make every attempt to minimize the time between randomization and surgery (i.e, no more than 7 to 10 days). Patients will be considered part of the study cohort as soon as they have been randomly allocated to either the Treatment or Control group. This time point will also be considered as the start of follow-up. For patients allocated to the Investigational Device group, the starting point of follow-up for surgical mortality and surgical complications will start as of the date when the surgical procedure is performed (or attempted). The acute response to device implant will be monitored intraoperatively via continuous electrocardiographic cardiac monitoring, arterial pressure lines, transesophageal echocardiography (TEE), and pulmonary artery catheter. Patients receiving the investigational device are expected to remain hospitalized for 5 to 14 days. Patients assigned to the control group will continue on standard medical therapy (without the investigational device).
Follow-up in this study is divided into two phases. During the first phase, referred to as the "efficacy phase", repeat testing of patient functional and cardiac structural parameters will be conducted at follow-up visits scheduled at 3 months and 6 months, and every 6 months thereafter. Follow-up testing will be supplemented by a 30 day (post randomization) telephone contact with all patients. The efficacy phase of the trial will end on a common closing date after a minimum of 6 months of follow-up (i.e., after the last patient enrolled has been completed the 6 month visit). At that point data analysis will be performed and an initial study report will be generated. Following completion of the efficacy phase, long-term monitoring will continue through each patient's 24-month visit. This second phase is referred to as the "extended follow-up phase". During this phase, data collection will be focused on long-term safety and will be conducted at 6-month intervals.
Patient's randomized to the control group and completing the 12 month visit will be provided the option of enrolling in Clinical Study LSH-11-001: An Open Label Rollover Trial for Patients Randomized to the Control Group of Study LSH-10-001. Patients must continue to meet the inclusion and exclusion criteria as stated in Study LSH-10-001 to be eligible for Study LSH-11-001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algisyl-LVR | Experimental | Device: Algisyl-LVRAlgisyl-LVR™ device (implants) administered during a surgical procedure. |
| Standard Medical Therapy | Active comparator | Drug: Standard medical therapyas per protocol |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patients must be able and willing to give written informed consent
- The patients will be adult (age ≥ 18 years and ≤ 79 years) males or females
- The patients must be on stable, evidence-based therapy for heart failure
- The patients will have a left ventricular ejection fraction equal to or less than 35% via echocardiography, cardiac catheterization, radionuclide scan, or magnetic resonance imaging (measured within the last 30 days)
- The patients will have a left ventricular end diastolic dimension indexed to body surface area (LVEDDi) of 30 to 40mm/m2 (LVEDD/BSA) (measured within the last 30 days)
Key exclusion criteria (13 listed)
- Patients for whom it is planned to receive CABG, MVR, heart transplantation or LVAD within the next 6 months.
- Patients presenting with cardiogenic shock.
- Patients who have undergone a previous mid-sternotomy surgical procedure are excluded unless the surgeon's assessment is that the left sided limited thoracotomy is feasible and considered reasonable surgical risk.
- Patients presenting with a restrictive cardiomyopathy such as due to amyloidosis, sarcoidosis, or hemochromatosis
- Patient with a history of constrictive pericarditis
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 |
|---|---|---|
| Algisyl-LVRAlso: intramyocardial injections of Alginate hydrogelAlgisyl-LVR™ device (implants) administered during a surgical procedure | Device | Algisyl-LVR |
| Standard medical therapyAlso: evidence-based therapy for heart failure, heart failure medications, drug therapyas defined per protocol | Drug | Standard Medical Therapy |
Primary outcome
peak VO2
Time frame: 6 months
The primary effectiveness endpoint will be a comparison of change in Peak VO2 from baseline to 6 months of follow-up between the Algisyl-LVR and medically managed arms with the intention to prove superiority in improvement in Peak VO2 associated with the Algisyl-LVR study group as compared to the medically managed study group. Evaluation of the cardiopulmonary exercise testing will be conducted by a central, blinded core laboratory.
1 secondary outcome
30 day all cause mortality
Time frame: 30 days
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 15 Mar 2017.
- Results publication: PubMed 26082085Anker SD, Coats AJ, Cristian G, Dragomir D, Pusineri E, Piredda M, Bettari L, Dowling R, Volterrani M, Kirwan BA, Filippatos G, Mas JL, Danchin N, Solomon SD, Lee RJ, Ahmann F, Hinson A, Sabbah HN, Mann DL. A prospective comparison of alginate-hydrogel with standard medical therapy to determine impact on functional capacity and clinical outcomes in patients with advanced heart failure (AUGMENT-HF trial). Eur Heart J. 2015 Sep 7;36(34):2297-309. doi: 10.1093/eurheartj/ehv259. Epub 2015 Jun 16.
- Results publication: PubMed 26555602Mann DL, Lee RJ, Coats AJ, Neagoe G, Dragomir D, Pusineri E, Piredda M, Bettari L, Kirwan BA, Dowling R, Volterrani M, Solomon SD, Sabbah HN, Hinson A, Anker SD. One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure. Eur J Heart Fail. 2016 Mar;18(3):314-25. doi: 10.1002/ejhf.449. Epub 2015 Nov 11.
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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.
Maurizio Volterani, MD principal investigator
IRCCS San Raffaele Pisana
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Algisyl-LVR and Standard medical therapy in people with Heart Failure and Dilated Cardiomyopathy, run by LoneStar Heart, Inc. at 18 sites in 6 countries.
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 9 inclusion and 13 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 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, Germany, Romania, Australia, Netherlands and 1 more country. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
peak VO2 (time frame: 6 months). 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 NCT01311791, which also lists 2 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 15 Mar 2017.