Heart FailureNECTAR-HFNCT01385176
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
A study testing Implant of investigational device system, Titration during the randomization phase and Titration after the randomization phase in people with Heart Failure and Congestive Heart Failure, run by Boston Scientific Corporation at 21 sites in 8 countries.
Trial summary
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestive Heart Failure
- What is being tested?
- Implant of investigational device system, Titration during the randomization phase and Titration after the randomization phase
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 21 Sep 2011to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or above, and of legal age to give informed consent specific to national laws
- Willing and capable of providing informed consent
- Capable of participating in all testing associated with this clinical investigation
- Stable symptomatic heart failure NYHA class II-III
- Left ventricular (LV) ejection fraction equal or smaller than 35 %
- Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater
- Prescribed to optimal pharmacologic therapy
Who cannot join
- QRS larger than 130 ms
- Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment
- Patients unable to tolerate anesthesia required for implant
- Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 90 days before enrollment
- Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
- Patients with persistent or permanent atrial fibrillation within 90 days prior to enrollment
Show all 31Show fewer
- Pacemaker indicated patients
- Patients whose heart failure is due to congenital heart disease
- Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP,APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment
- Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- Patients with documented chronic obstructive lung disease
- Patients on or indicated for renal dialysis
- Type 1 diabetic patients
- Type 2 diabetic patients that have been treated with insulin for more than 5 years prior to enrollment
- Patients with a life expectancy of less than 12 months per physician judgment
- Patients involved in any concurrent clinical investigation
- Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
- Patients with a prior cardiac transplant or expecting a heart transplant operation within the next 12 months
- Patients with a prior vagotomy
- Patients with prior or existing vagal nerve stimulation treatment
- Patients implanted with any active implantable medical device other than a left sided single or dual chamber implantable cardioverter defibrillator (ICD) with bipolar sensing, or a left sided CRT device with each sensing channel programmed to either bipolar sensing or no sensing. All CRT patients must have had CRT for at least 1 year prior to enrollment. The total number of CRT patients will not exceed 30
- Patients with locally implanted semi-/permanent devices such as vascular catheters, etc. that would interfere with the NECTAR-HF study system
- Patients with previously implanted devices on the right side that became infected before removal
- Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system on the right side of the neck (Thyroid/parathyroid, carotid artery etc)
- Patients with known recurrent nerve paralysis
- Patients who have undergone radiotherapy for thyroid disease/cancer
- Patients who have existing or prior tracheotomy
- Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
- Patients with carotid murmur/vascular bruit/carotid artery lesion
- Patients with known/suspected vascular malformation in carotid/vertebral circulatory bed
- Patients who are likely to need an MRI of the neck area because of previous medical conditions
Trial locations and contacts
21 sites in 8 countries.
21 sites in 8 countries
United Kingdom5 sites
University Hospitals Bristol, NHS Foundation Trust
Bristol, England, BS2 8HW
Liverpool Heart and Chest Hospital, NHS Foundation Trust
Liverpool, England, L14 3PD
The Heart Hospital, University College London Hospitals, NHS Foundation Trust
London, England, W1G 8PH
Imperial College Healthcare NHS Trust, St. Mary's Hospital
London, England, W2 1NY
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Germany4 sites
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, 16321
Universitätsmedizin Göttingen
Göttingen, 37075
Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitätsklinikum Leipzig
Leipzig, 04103
Italy3 sites
Azienda Ospedaliera Niguarda Cà Granda
Milan, 20162
A. O. Dei Colli - Monaldi
Naples, 80131
Policlinico San Matteo
Pavia, 27100
Spain3 sites
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Doce de Octubre
Madrid, 28041
Clínica Universitaria de Navarra, Avenida Pio XII s/n
Pamplona, Navarre, 31008
France2 sites
CHRU de Lille - Hôpital Cardiologique
Lille, 59037
Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy
Vandœuvre-lès-Nancy, Nancy, 54500
Netherlands2 sites
Catharina Ziekenhuis Eindhoven
Eindhoven, 5623EJ
UMC Utrecht
Utrecht, 3584CX
About this study
Official title: Neural Cardiac Therapy for Heart Failure Study
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.
Read the detailed description
The objectives of this study are to assess the impact of right vagal nerve stimulation on left ventricular remodeling, functional capacity, quality of life, and other measures in heart failure patients over a 6-month period. In addition, the study will assess the safety of the NECTAR-HF study system over an 18-month period.
- Conditions
- Heart Failure, Congestive Heart Failure
- Being tested
- Implant of investigational device system, Titration during the randomization phase, Titration after the randomization phase, Blood Draw
- Keywords
- Heart failure, Congestive heart failure, New York Heart Association Class II-III, Vagal therapy, Vagal nerve stimulation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of investigational device systemDevice
Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region.
Titration during the randomization phaseProcedure or surgery
Amplitude of the chronically delivered vagus nerve stimulation in the experimental arm was adjusted to the highest tolerable by patient value. No chronically delivered vagus nerve stimulation in the control arm during the randomization phase.
Titration after the randomization phaseProcedure or surgery
Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study.
Blood DrawDiagnostic test
Blood draw before implant and 6 months after implant at the end of the randomization phase.
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Experimental | Implant of investigational device system for vagus nerve stimulation. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period.
The experimental arm was receiving vagus nerve stimulation during the first 6 months after implant.
Titration during the randomization phase with delivery of highest tolerable by patient stimulation current.
Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current. Receives: Device: Implant of investigational device system; Procedure: Titration during the randomization phase; Procedure: Titration after the randomization phase; Diagnostic Test: Blood Draw |
| Control | Sham comparator | Implant of investigational device system for vagus nerve stimulation. Control group was implanted with study system like the experimental arm, but was not receiving experimental vagus nerve stimulation therapy during the first 6 months after implant. 6-month after implant a cross-over took place and the control arm also started to receive experimental vagus nerve stimulation.
Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current. Receives: Device: Implant of investigational device system; Procedure: Titration after the randomization phase; Diagnostic Test: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular End-systolic Dimension (LVESD)
Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm.
The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD.
The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).
Measured: LVESD at Baseline and at 6-months post Baseline
Percentage of Surviving Participants
As pre-specified in the study protocol, the All-cause Survival endpoint combined both groups into one analysis population. Subjects contributed data according to the follow-up period during they received VNS therapy (Implant through 18 months for Therapy subjects, 6 through 18 months for Control subjects). Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.
Measured: 18-months
Secondary outcomes (3)
LVEF, Left Ventricular Ejection Fraction
LVEF, left ventricular ejection fraction.
Measured: LVEF at Baseline and at 6-months after Baseline
Exercise Capacity, Peak VO2
Assessment of functional capacity (e.g., peak VO2) as measures related to patient heart failure status.
Measured: Measurements at Baseline and at 6-months after Baseline
LVESV, Left Ventricular End Systolic Volume
Measurements of LVESV, left ventricular end systolic volume at Baseline and 6 months after Baseline in the Control Arm and in the Therapy Arm
Measured: At Baseline and at 6-months after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2011 (estimated)
- Study start21 Sep 2011
- Primary completionMay 2014
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients were randomized in a 2:1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The primary endpoint was the change in LVend systolic diameter (LVESD) at 6 months for control vs. therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-h Holter, and circulating biomarkers.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Faiez Zannad, M.D., Principal investigator, Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385176
- Sponsor's protocol ID
- NECTAR-1109
- Acronym
- NECTAR-HF
- Status last verified
- Sep 2026
- First submitted
- 28 Jun 2011
- Last updated
- 25 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F. Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF. Eur J Heart Fail. 2014 Jun;16(6):692-9. doi: 10.1002/ejhf.80. Epub 2014 May 20.
PubMed 24846173Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.
PubMed 25176942De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol. 2017 Oct 1;244:229-234. doi: 10.1016/j.ijcard.2017.06.036. Epub 2017 Jun 10.
PubMed 28663046
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Cardiac Therapy for Heart Failure Study
- ClinicalTrials.gov ID
- NCT01385176
- Acronym / sponsor ID
- NECTAR-HF / NECTAR-1109
- Conditions
- Heart Failure, Congestive Heart Failure
- Keywords
- Heart failure, Congestive heart failure, New York Heart Association Class II-III, Vagal therapy, Vagal nerve stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2011 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 30 Jun 2011 (estimated)
- Results
- Posted 6 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.
Detailed description
The objectives of this study are to assess the impact of right vagal nerve stimulation on left ventricular remodeling, functional capacity, quality of life, and other measures in heart failure patients over a 6-month period. In addition, the study will assess the safety of the NECTAR-HF study system over an 18-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomized in a 2:1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The primary endpoint was the change in LVend systolic diameter (LVESD) at 6 months for control vs. therapy, with secondary endpoints of other echocardiography measurements, exercise capacity, quality-of-life assessments, 24-h Holter, and circulating biomarkers.
| Arm | Type | Receives |
|---|---|---|
| Therapy | Experimental | Device: Implant of investigational device system, Procedure: Titration during the randomization phase, Procedure: Titration after the randomization phase, Diagnostic Test: Blood DrawImplant of investigational device system for vagus nerve stimulation. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period. The experimental arm was receiving vagus nerve stimulation during the first 6 months after implant. Titration during the randomization phase with delivery of highest tolerable by patient stimulation current. Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current. |
| Control | Sham comparator | Device: Implant of investigational device system, Procedure: Titration after the randomization phase, Diagnostic Test: Blood DrawImplant of investigational device system for vagus nerve stimulation. Control group was implanted with study system like the experimental arm, but was not receiving experimental vagus nerve stimulation therapy during the first 6 months after implant. 6-month after implant a cross-over took place and the control arm also started to receive experimental vagus nerve stimulation. Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 or above, and of legal age to give informed consent specific to national laws
- Willing and capable of providing informed consent
- Capable of participating in all testing associated with this clinical investigation
- Stable symptomatic heart failure NYHA class II-III
- Left ventricular (LV) ejection fraction equal or smaller than 35 %
Key exclusion criteria (31 listed)
- QRS larger than 130 ms
- Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment
- Patients unable to tolerate anesthesia required for implant
- Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 90 days before enrollment
- Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
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 |
|---|---|---|
| Implant of investigational device systemVagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region. | Device | Control, Therapy |
| Titration during the randomization phaseAmplitude of the chronically delivered vagus nerve stimulation in the experimental arm was adjusted to the highest tolerable by patient value. No chronically delivered vagus nerve stimulation in the control arm during the randomization phase. | Procedure or surgery | Therapy |
| Titration after the randomization phaseAmplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study. | Procedure or surgery | Control, Therapy |
| Blood DrawBlood draw before implant and 6 months after implant at the end of the randomization phase. | Diagnostic test | Control, Therapy |
Primary outcome
Change in Left Ventricular End-systolic Dimension (LVESD)
Time frame: LVESD at Baseline and at 6-months post Baseline
Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm. The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).
Percentage of Surviving Participants
Time frame: 18-months
As pre-specified in the study protocol, the All-cause Survival endpoint combined both groups into one analysis population. Subjects contributed data according to the follow-up period during they received VNS therapy (Implant through 18 months for Therapy subjects, 6 through 18 months for Control subjects). Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.
3 secondary outcomes
LVEF, Left Ventricular Ejection Fraction
Time frame: LVEF at Baseline and at 6-months after Baseline
Exercise Capacity, Peak VO2
Time frame: Measurements at Baseline and at 6-months after Baseline
LVESV, Left Ventricular End Systolic Volume
Time frame: At Baseline and at 6-months after Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24846173De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F. Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF. Eur J Heart Fail. 2014 Jun;16(6):692-9. doi: 10.1002/ejhf.80. Epub 2014 May 20.
- Results publication: PubMed 25176942Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.
- Results publication: PubMed 28663046De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol. 2017 Oct 1;244:229-234. doi: 10.1016/j.ijcard.2017.06.036. Epub 2017 Jun 10.
- Individual participant dataSharing planned: No
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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.
Faiez Zannad, M.D. principal investigator
Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant of investigational device system, Titration during the randomization phase and Titration after the randomization phase in people with Heart Failure and Congestive Heart Failure, run by Boston Scientific Corporation at 21 sites in 8 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 7 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom, Germany, Italy, Spain, France and 3 more countries. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 6 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Left Ventricular End-systolic Dimension (LVESD) (time frame: LVESD at Baseline and at 6-months post Baseline). The study lists 2 primary outcomes in all. 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 NCT01385176, which also lists 3 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 25 Sep 2026.