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Heart FailureMORE CRT MPPNCT02006069

MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

A study testing MPP in people with Heart Failure, run by Abbott Medical Devices at 206 sites in 30 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
MPP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,850 participants
Where
206 sitesin 30 countries
Study dates
Dec 2013to 30 May 2021
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

  • Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
  • Must be willing and able to comply with study requirements
  • Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Who cannot join

  • Already had a CRT device implanted
  • Myocardial Infarction, unstable angina within 40 days prior the enrollment
  • Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
  • Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
  • Primary valvular disease
  • Atrial Fibrillation:
Show all 16Show fewer
  • Persistent AF at the time of enrollment
  • Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
  • History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
  • Unable to comply with the follow up schedule
  • Less than 18 years of age
  • Pregnant or are planning to become pregnant during the duration of the investigation
  • Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
  • Undergone a cardiac transplantation
  • Life expectancy < 12 months
  • Currently participating in any other clinical investigation

Trial locations and contacts

206 sites in 30 countries.

206 sites in 30 countries

Germany33 sites

  • Universitäts-Herzzentrum Freiburg - Bad Krozingen

    Bad Krozingen, Baden-Wurttemberg, 79189

  • Kerckhoff-Klinik gGmbH

    Bad Nauheim, Hesse, 61231

  • Herz-und Diabetes Zentrum NRW

    Bad Oeynhausen

  • Schuchtermann-Schillersche Kliniken

    Bad Rothenfelde

  • Charite Campus Virchow Klinikum

    Berlin

  • Universitatsmedizin Berlin - Campus Benjamin Franklin (CBF)

    Berlin

  • Klinikum Bielefeld

    Bielefeld

  • Berufsgenossenschaftliche Kliniken Bergmannsheil

    Bochum

  • Klinikum Coburg

    Coburg

  • Medizinische Einrichtungen der Universität zu Köln

    Cologne, North Rhine-Westphalia, 50931

  • Evangelisches Krankenhaus Kalk gGmbH

    Cologne, North Rhine-Westphalia, 51103

  • St. Vinzenz-Hospital

    Cologne

  • Helios-Klinikum Erfurt GmbH

    Erfurt

  • Kliniken der Friedrich-Alexander-Universität

    Erlangen

  • Elisabeth-Krankenhaus Essen GmbH

    Essen

  • Herz- und Gefäßzentrum am Krankenhaus Neu-Bethlehem

    Göttingen, Lower Saxony, 37073

  • Universitätsmedizin Göttingen Georg-August-Universität

    Göttingen

  • Universitatsklinikum Greifswald

    Greifswald

  • Klinikum Gütersloh gGmbH

    Gütersloh

  • Albertinen-Krankenhaus Hamburg

    Hamburg, 22457

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Klinikum Ingolstadt

    Ingolstadt

  • Klinikum St. Georg gGMbH

    Leipzig

  • Universitatsklinikum Leipzig

    Leipzig

  • Klinikum Ludenscheid

    Lüdenscheid

  • St.-Marien-Hospital GmbH

    Lünen

  • Deutsches Herzzentrum München des Freistaates Bayern

    München

  • Universitatsklinikum Muenster

    Münster

  • Klinikum Oldenburg

    Oldenburg

  • Hegau-Bodensee-Hochrhein-Kliniken GmbH

    Singen, Baden-Wurttemberg, 78224

  • Krankenhaus der Barmherzigen Bruder

    Trier

  • Kliniken Villingen-Schwenningen

    Villingen-Schwenningen

  • Universitätsklinikum Würzburg

    Würzburg

Other trials in Germany

United States32 sites

  • McLaren Health Care Corporation

    Auburn Hills, Michigan, 48326

  • Comprehensive Cardiovascular

    Bakersfield, California, 93309

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Erlanger Medical Center

    Chattanooga, Tennessee, 37403

  • Samaritan Heart & Vascular Institute - Cardiology Dept.

    Corvallis, Oregon, 97330

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9016

  • St. Elizabeth Medical Center - South Unit

    Edgewood, Kentucky, 41017

  • Baylor All Saints Medical Center at Fort Worth

    Fort Worth, Texas, 76104

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • St. Francis Hospital

    Greenville, South Carolina, 29601

  • Cardiology Associates of Fairfield County, PC

    Haddon Heights, New Jersey, 08035

  • Memorial Katy Cardiology Associates

    Houston, Texas, 77094

  • Heart Center Research, LLC.

    Huntsville, Alabama, 35801

  • Scripps Health

    La Jolla, California, 92037

  • Colorado Heart & Vascular, P.C.

    Lakewood, Colorado, 80228

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Vivek Mangla, MD

    Lufkin, Texas, 75904

  • Coliseum Medical Centers

    Macon, Georgia, 31217

  • Methodist University Hospital

    Memphis, Tennessee, 38104

  • Cardiovascular Associates of Mesa

    Mesa, Arizona, 85206

  • MidMichigan Medical Center-Midland

    Midland, Michigan, 48670

  • CHI Health Creighton University Medical Center-Bergan Mercy

    Omaha, Nebraska, 68124

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona, 85018

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Cardiac Rhythm Specialists, Inc.

    Reseda, California, 91335

  • Redmond Regional Medical Center

    Rome, Georgia, 30165

  • San Diego Cardiac Center

    San Diego, California, 92123

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • EP Heart

    The Woodlands, Texas, 77384

  • Munson Medical Center

    Traverse City, Michigan, 49684

Other trials in United States

France21 sites

  • CHU Cavale Blanche

    Brest

  • CHU Trousseau

    Chambray-lès-Tours

  • CHU François Mitterrand Dijon Bourgogne

    Dijon

  • CHRU Albert Michallon

    Grenoble

  • CHRU Lille

    Lille

  • Hopital Saint Philibert

    Lomme

  • Hôpital Clairval

    Marseille, Alpes, 13009

  • Hôpital Saint Joseph

    Marseille

  • Centre Hospitalier de Belfort-Montbeliard

    Montbéliard

  • CHU Montpellier

    Montpellier

  • CHU de Nancy - Hopital de Brabois

    Nancy

  • CHU Hopital G. & R. Laënnec

    Nantes, 44093

  • Nouvelles cliniques Nantaises

    Nantes

  • Centre Cardiologique Du Nord

    Paris

  • Hopital Pitiè Salpetrière

    Paris

  • Institute Cardio. Paris-Sud - Institut Jacques Cartier

    Paris

  • CHRU Hôpital de Pontchaillou

    Rennes, 35033

  • CHRU Rouen Hospital Charles Nicolle

    Rouen

  • CHR de La Reunion - Site du CHFG

    Saint-Denis, 97405

  • Centre Hospitalier de Valence

    Valence

  • Clinique du Tonkin

    Villeurbanne

Other trials in France

Italy21 sites

  • Az.Osp.Universitaria Consorziale Policlinico

    Bari

  • Azienda Ospedaliera Di Venere

    Bari

  • Policlinico S.Orsola Malpighi

    Bologna

  • Az. Osp. Spedali Civili di Brescia

    Brescia

  • Azienda Ospedaliera S. Anna e S Sebastiano

    Caserta

  • Presidio Osp. Vito Fazzi

    Lecce

  • Clinica Mediterranea

    Naples

  • Ospedale dei Pellegrini

    Naples

  • Ospedale S. Giovanni Bosco

    Naples

  • Az Osp.Universitaria Maggiore della Carità

    Novara

  • Università degli Studi di Padova

    Padova, 35128

  • Casa di Cura Dott. Pederzoli

    Peschiera del Garda

  • Az. Osp. Universitaria Pisana-Presidio Santa Chiara

    Pisa

  • Ospedale di Portogruaro

    Portogruaro

  • Azienda Ospedaliera "Civile - Maria Paternò Arezzo"

    Ragusa

  • Ospedale Madre G. Vannini

    Roma, 00177

  • Policlinico Casilino

    Roma

  • Ospedale S. Giovanni Calibita Fatebenefratelli di Roma

    Rome

  • Azienda Ospedaliera S. Anna

    San Fermo della Battaglia, 1 22020

  • Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

  • Ospedale Civile Maggiore di Verona Borgo Trento

    Verona

Other trials in Italy

Spain14 sites

  • Hospital Universitario A Coruña

    A Coruña

  • Hospital Universitario Infanta Cristina

    Badajoz

  • Hospital de la Santa Creu y Sant Pau

    Barcelona

  • Hospital Universitario Virgen de la Nieves

    Granada

  • Complexo Hospitalario Universitario de Santiago

    Madrid, 15706

  • Fundación Jiménez Díaz

    Madrid, 28040

  • Hospital General Universitario Gregorio Maranon

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Universitario Doce de Octubre

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • HCU Virgen de la Victoria

    Málaga

  • Hospital Universitari i Politecnic La Fe

    Valencia

  • Hospital Alvaro Cunqueiro

    Vigo

  • Hospital Universitario Miguel Servet

    Zaragoza

Other trials in Spain

Canada12 sites

  • Foothills Medical Centre

    Calgary

  • Royal Alexandra Hospital

    Edmonton

  • QEII Health Sciences

    Halifax

  • Kingston General Hospital

    Kingston

  • Hôtel Dieu de CHUM

    Montreal

  • Institut de Cardiologie de Montreal

    Montreal

  • McGill University Health Centre General Hospital

    Montreal

  • Institut de Cardiologie de Quebec

    Sainte-Foy

  • CHUS Fleurimont

    Sherbrooke, J1H 5N4

  • HSC, Eastern Health

    St. Johns

  • Rouge Valley Centenary

    Toronto

  • St. Paul's Hospital

    Vancouver

Other trials in Canada

United Kingdom10 sites

  • Wansbeck General Hospital

    Ashington

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • The Royal Sussex Country Hospital

    Brighton

  • Golden Jubilee National Hospital

    Glasgow

  • Kings College Hospital

    London

  • St. Thomas Hospital

    London

  • Manchester Heart Center, Manchester Royal Infirmary

    Manchester, M13 9WL

  • John Radcliffe Hospital

    Oxford

  • Southampton General Hospital

    Southampton

  • The Great Western Hospital

    Swindon

Other trials in United Kingdom

India8 sites

  • Care Institute of Medical Sciences

    Ahmedabad

  • Fortis Hospital

    Bangalore, Karnataka, 560076

  • Postgraduate Institute of Medical Education & Research

    Chandigarh

  • Apollo Hospital

    Chennai

  • Medanta - The Medicity Hospital

    Gurgaon, Haryana, 122 001

  • CARE Banjara

    Hyderabad

  • Medanta Medicity Hospital

    New Delhi, 110017

  • Escorts Heart Institute and Research Centre

    New Delhi

Other trials in India

Portugal6 sites

  • Hospital de Braga

    Braga

  • Centro Hospitalar do Alto Ave, Unidade de Guimarães

    Creixomil, 4835-044

  • Hospital de Santa Cruz

    Lisbon

  • Hospital Garcia de Orta, EPE

    Lisbon

  • Santa Maria Hospital

    Lisbon

  • Centro Hospitalar Vila Nova Gaia

    Vila Nova de Gaia, 4434 502

Other trials in Portugal

South Korea6 sites

  • Sejong General Hospital

    Bucheon-si

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Samsung Medical Center

    Seoul, Gangnam-gu, 135-710

  • Seoul St. Mary's Hospital

    Seoul, Seocho-gu, 137-701

  • Seoul National University Hospital

    Seoul

  • Yonsei University Health System

    Seoul

Other trials in South Korea

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide

  • Flinders Medical Centre

    Bedford Park, 5042

  • St. Andrews War Memorial Hospital

    Brisbane

  • The Alfred Hospital

    Melbourne

  • Westmead Hospital

    Westmead

Other trials in Australia

Netherlands5 sites

  • Amsterdam Academic Medical Center (AMC)

    Amsterdam

  • Catharina Ziekenhuis

    Eindhoven

  • Medisch Spectrum Twente

    Enschede

  • Twee Steden Ziekenhuis

    Tilburg, North Brabant, 5042 AD

  • Isala Ziekenhuis

    Zwolle

Other trials in Netherlands

Poland4 sites

  • Gornoslaskie Centrum Medyczne im.prof. Leszka Gieca

    Katowice, Silesian Voivodeship, 40-635

  • Wojewodzki Specjalistyczny Szpital im. Bieganskiego

    Lodz

  • Szpital Kliniczny Premienienia Panskiego

    Poznan, Greater Poland Voivodeship, 61-848

  • Slaskie Centrum Chorob Serca

    Zabrze, Silesian Voivodeship, 41-800

Other trials in Poland

Austria3 sites

  • Krankenhaus der Stadt St. Poelten

    Sankt Pölten

  • Krankenhaus Hietzing

    Vienna, 1130

  • Wilhelminenspital

    Vienna

Other trials in Austria

Denmark3 sites

  • Aalborg Sygehus Syd

    Aalborg, North Denmark, DK-9000

  • Skejby University Hospital

    Aarhus

  • Odense University Hospital

    Odense, Fyn, 5000

Other trials in Denmark

Israel3 sites

  • Rabin Medical Center

    Petah Tikva, 49100

  • Sheba Medical Center

    Ramat Gan

  • Tel Aviv Medical Center

    Tel Aviv, 64239

Other trials in Israel

Belgium2 sites

  • Hopital Erasme

    Brussels

  • St. Joseph Gilly

    Gilly

Other trials in Belgium

Colombia2 sites

  • Angiografia Clinica de Occidente

    Cali

  • Clínica Cardio VID

    Medellín

Other trials in Colombia

Finland2 sites

  • Keski-Suomi Central Hospital

    Jyväskylä

  • Turku University Hospital

    Turku

Other trials in Finland

Puerto Rico2 sites

  • Arrhythmia Group

    Ponce

  • Heart Rhythm Management

    San Juan

Other trials in Puerto Rico

Saudi Arabia2 sites

  • King Fahad Armed Forces Hospital

    Jeddah, 21159

  • King Fahad Medical City

    Riyadh

Other trials in Saudi Arabia

Taiwan2 sites

  • Chang Gung Memorial Hospital

    Linkou District, 333

  • National Taiwan University

    Taipei City, Taipei, 10002

Other trials in Taiwan

China1 site

  • Prince of Wales Hospital

    Hong Kong

Other trials in China

Greece1 site

  • The Onassis Cardiac Center

    Athens, 17674

Other trials in Greece

Lebanon1 site

  • American University of Beirut Medical Center

    Beirut

Other trials in Lebanon

Malaysia1 site

  • Institut Jantung Negara

    Kuala Lumpur, 50400

Other trials in Malaysia

Malta1 site

  • Mater Dei Hospital

    Paola

Other trials in Malta

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

Sweden1 site

  • Karolinska University Hospital Huddinge

    Stockholm

Other trials in Sweden

Switzerland1 site

  • Hopital Cantonal Universitaire de Geneva

    Geneva

Other trials in Switzerland

About this study

Official title: MOre REsponse on Cardiac Resynchronization Therapy (CRT) With MultiPoint Pacing (MPP)

The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

Read the detailed description

This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.

Conditions
Heart Failure
Being tested
MPP
Keywords
CRT, non responders, MultiPoint Pacing (MPP)
Medical subject headings
Heart Failure, Creatine deficiency, X-linked

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPPDevice

    All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.

    The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion ("no mandated MPP programming") and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements ("mandated MPP programming").

Study groups in NCT02006069
Study groupRoleWhat they receive
MPP ONExperimentalMPP ON: feature is enabled
Receives: Device: MPP
MPP OFFNo interventionMPP OFF: feature not enabled

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Non-responder Patients Who Converted to Responders

    The primary endpoint of this study is evaluated at 12 months after enrollment and it is defined as the percentage of non-responder patients converted to responders after 6 months of MPP feature turned ON compared to baseline, as measured by Left Ventricular End Systolic Volume (LVESV) reduction of at least 15%.

    Measured: Non-responder to responder conversion rate between randomization at 6 months and 12 months

Secondary outcomes (6)

  1. Reduction of Left Ventricular End-systolic Volume (LVESV) in Acute Phase

    Reduction of LVESV between baseline and 6 Months visit

    Measured: Baseline vs 6 Months

  2. Clinical Composite Score Evaluation

    Packer's Clinical Composite Score evaluation between baseline and 12 months as defined below,

    • Worsened: the patient died because of cardiovascular reasons OR experienced a HF event OR demonstrated worsening in NYHA functional class, or had worsening of patient global assessment (PGA) score compared with the last observation
    • Improved: the patient survived without an HF event AND demonstrated either improvement in NYHA functional class or improvement in PGA score or both compared with the last observation
    • Unchanged: the patient was neither improved nor worsened

    Measured: Baseline vs 12 Months

  3. Reverse Left Ventricular (LV) Remodeling

    Evaluation of Reverse LV remodeling, measured as changed in left ventricular end-systolic volume (LVESV) from baseline to 12 months

    Measured: Baseline vs 12 Months

  4. NYHA Class Changes

    Evaluation of NYHA Class changes between baseline and 12 months. Increasing functional class is associated with greater risk of death or hospitalization.

    Measured: Baseline vs 12 Months

  5. 6MWT Changes

    Evaluation of the patient's activity status using 6 Minutes Walking Test changes from baseline to 12 months FU

    Measured: Baseline vs 12 Months

  6. Patient's QoL Score Changes (MLWHF)

    Evaluation of patient's Quality of Life score using Minnesota Living with Heart Failure (MLWHF) Questionnaires. The MLWHF Questionnaire consists of 21 questions with a range in overall scores of 0 to 105 points (lower scores indicate better quality of life).

    Measured: Baseline vs 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completion30 May 2021
  4. Study completion30 May 2021

Why it stopped: The steering committee had decided to discontinue enrollment because the interim analysis showed a low probability that the study would meet the primary endpoint. The interim analysis did not demonstrate any safety concerns with activating MPP.

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
5,850 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02006069
Sponsor's protocol ID
CR-13-006-ID-HF
Acronym
MORE CRT MPP
Status last verified
Apr 2023
First submitted
23 Sep 2013
Last updated
17 May 2023
Data monitoring committee
No
Individual data sharing
No

Publications

  • Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Calo L, Vicentini A, Concha JF, Thibault B. Cardiac resynchronization therapy non-responder to responder conversion rate in the more response to cardiac resynchronization therapy with MultiPoint Pacing (MORE-CRT MPP) study: results from Phase I. Eur Heart J. 2019 Sep 14;40(35):2979-2987. doi: 10.1093/eurheartj/ehz109.

    PubMed 30859220

  • Leclercq C, Burri H, Curnis A, Delnoy PP, Rinaldi CA, Sperzel J, Lee K, Cohorn C, Thibault B; MORE-CRT MPP Investigators. Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP-PHASE II). Am Heart J. 2019 Mar;209:1-8. doi: 10.1016/j.ahj.2018.12.004. Epub 2018 Dec 8.

    PubMed 30616009

Questions about this trial

What is this clinical trial studying?

A study testing MPP in people with Heart Failure, run by Abbott Medical Devices at 206 sites in 30 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 3 inclusion and 16 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: stopped early, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 206 sites in Germany, United States, France, Italy, Spain and 25 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. 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 17 May 2023). 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?

Percentage of Non-responder Patients Who Converted to Responders (time frame: Non-responder to responder conversion rate between randomization at 6 months and 12 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 NCT02006069, 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 17 May 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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