This Study Tests Empagliflozin in Patients With Chronic Heart Failure With Preserved Ejection Fraction (HFpEF). The Study Looks at How Far Patients Can Walk in 6 Minutes and at Their Heart Failure Symptoms.

November 12, 2020 updated by: Boehringer Ingelheim

A Phase III Randomised, Double-blind Trial to Evaluate the Effect of 12 Weeks Treatment of Once Daily EMPagliflozin 10 mg Compared With Placebo on ExeRcise Ability and Heart Failure Symptoms, In Patients With Chronic HeArt FaiLure With Preserved Ejection Fraction (HFpEF) (EMPERIAL - Preserved)

The primary objective of the study is to evaluate the effect of empagliflozin 10 mg versus placebo on exercise ability using the 6 minute walk test (6MWT) in patients with chronic heart failure (CHF) with preserved ejection fraction (LVEF > 40%).

Secondary objectives are to assess Patient-Reported Outcome (PRO)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
315

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • Queensland
      • Birtinya, Queensland, Australia, 4575
        • University of the Sunshine Coast
    • Victoria
      • Frankston, Victoria, Australia, 3199
        • Peninsular Health CV Research Unit
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
    • Ontario
      • Mississauga, Ontario, Canada, L5K 2L3
        • KMH Cardiology Centres Inc.
      • Toronto, Ontario, Canada, M4P 1E4
        • Toronto Heart Centre
      • Waterloo, Ontario, Canada, N2J 1C4
        • Sameh Fikry Medicine Professional Corporation
  • Germany
      • Bamberg, Germany, 96049
        • CIMS Studienzentrum Bamberg GmbH
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10787
        • Klinische Forschung Berlin GbR
      • Dresden, Germany, 01277
        • Cardiologicum Dresden und Pirna
      • Düsseldorf, Germany, 40225
        • Universitätsklinikum Düsseldorf
      • Frankfurt, Germany, 60596
        • IKF Pneumologie GmbH & Co. KG
      • Freiburg, Germany, 79106
        • Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
      • Köln, Germany, 50937
        • Universitätsklinikum Köln (AöR)
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg AöR
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
      • Würzburg, Germany, 97080
        • Universitätsklinikum Würzburg
  • Greece
      • Athens, Greece, 14233
        • General Hospital of Athens Konstantopoulio-Agia Olga
      • Athens, Greece, 15669
        • General Hospital of Athens "G. Gennimatas"
      • Chalkida, Greece, 34100
        • General Hospital of Chalkida
      • Herakleion, Crete, Greece, 71110
        • University General Hospital of Heraklion
      • Ioannina, Greece, 45500
        • Univ. Gen. Hosp. of Ioannina
      • Thessaloniki, Greece, 54636
        • University Hospital of Thessaloniki AHEPA
  • Italy
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino-IRCCS
      • Milano, Italy, 20142
        • Asst Santi Paolo E Carlo
      • Milano, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Mondovì (CN), Italy, 12084
        • Ospedale Regina Montis Regalis
      • Napoli, Italy, 80131
        • Università Federico II
      • Palermo, Italy, 90133
        • Universita degli Studi di Palermo
      • Roma, Italy, 00163
        • IRCCS San Raffaele
  • Norway
      • Grålum, Norway, N-1714
        • Sykehuset Østfold Kalnes
      • Oslo, Norway, N-0372
        • Oslo Universitetssykehus HF, Rikshospitalet
      • Stavanger, Norway, N-4011
        • Helse Stavanger, Stavanger Universitetssykehus
      • Trondheim, Norway, N-7030
        • St. Olavs Hospital, Universitetssykehuset i Trondheim
  • Poland
      • Bydgoszcz, Poland, 85-605
        • INTERCORE Medical Center
      • Bydgoszcz, Poland, 85681
        • 10.Military Clin.Hospital&Polyclinic
      • Krakow, Poland, 30-082
        • Leszek Bryniarski Specialized Medical Cabinet
      • Lodz, Poland, 91-425
        • Card.Cli.Mil.Med.Ac.Uni.Cli.Hosp. Cent.Vetera.Hosp.Lodz
      • Lodz, Poland, 92-213
        • Cent.Clin.Hosp.Med.Univ.Lodz,Electrocard
      • Lodz, Poland, 93-513
        • Provincial Specialist M. Kopernik Hospital
      • Pulawy, Poland, 24100
        • Independent Public Healthcare, Dept. of Cardiology, Pulawy
      • Warsaw, Poland, 02-097
        • Central Hospital of Medical Academy, Warsaw
      • Wroclaw, Poland, 50 981
        • 4. Military Clinical Hospital with Polyclinic SP ZOZ
  • Portugal
      • Carnaxide, Portugal, 2795
        • CHLO, EPE - Hospital de Santa Cruz
      • Coimbra, Portugal, 3041-801
        • CHUC - Centro Hospitalar e Universitário de Coimbra, EPE
      • Leiria, Portugal, 2410-197
        • Centro Hosp. de Leiria-Pombal
      • Lisboa, Portugal, 1169-024
        • CHLC, EPE - Hospital de Santa Marta
      • Lisboa, Portugal, 1449-005
        • CHLO, EPE - Hospital S. Francisco Xavier
      • Lisboa, Portugal, 1649-035
        • CHULN, EPE - Hospital de Santa Maria
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitário São João,EPE
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Badalona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Granada, Spain, 18004
        • Hospital de la Inmaculada Concepción
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de Las Nieves
      • Granada, Spain, 18001
        • Hospital San Rafael
      • Madrid, Spain, 28034
        • Hospital Ramón y Cajal
      • Madrid, Spain, 28006
        • Hospital La Princesa
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
  • Sweden
      • Göteborg, Sweden, 413 45
        • Sahlgrenska US, Göteborg
      • Göteborg, Sweden, 416 85
        • Sahlgrenska Universitetssjukhuset, Östra
      • Lund, Sweden, 221 85
        • Skånes universitetssjukhus, Lund
      • Stockholm, Sweden, 11446
        • Akardo Med Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Mobile Heart Specialists, PC
      • Saraland, Alabama, United States, 36571
        • The Center for Clinical Trials, Inc.
    • California
      • Huntington Beach, California, United States, 92648
        • California Heart Specialists
      • Stockton, California, United States, 95204
        • Manshadi Heart Institute, Inc
      • Torrance, California, United States, 90502
        • University of California Los Angeles
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Western Connecticut Health Network
    • Florida
      • Miami, Florida, United States, 33133
        • Infinite Clinical Research
      • Miami, Florida, United States, 33135
        • Advance Medical Research Center
      • Miami Beach, Florida, United States, 33140
        • Bio1 Clinical Research
      • North Miami Beach, Florida, United States, 33169
        • Pharmacology Research, LLC
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Gardens Research Center, LLC
      • Saint Augustine, Florida, United States, 32086
        • East Coast Institute for Research, LLC
      • Zephyrhills, Florida, United States, 33541
        • Cozy Research LLC
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Memorial Hospital
      • Warner Robins, Georgia, United States, 31093
        • Georgia Arrhythmia Consultants and Research Institute
    • Idaho
      • Boise, Idaho, United States, 83712
        • St Luke's Clinic - Idaho Cardiology Associates
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Northwest Heart Clinical Research, LLC
      • Gurnee, Illinois, United States, 60031
        • Clinical Investigation Specialists, Inc
      • Hazel Crest, Illinois, United States, 60429
        • Chicago Medical Research
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Midwest Heart and Vascular Specialists
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Grace Research, LLC
      • Shreveport, Louisiana, United States, 71107
        • Grace Research, LLC
      • West Monroe, Louisiana, United States, 71291
        • Clinical Trials of America LA, LLC
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • John D. Dingell VA Medical Center
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Med Research One
      • Springfield, Missouri, United States, 65807
        • Cox Medical Center South
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • The Docs
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson Medical School
    • New York
      • Albany, New York, United States, 12208
        • Albany Stratton VA Medical Center Albany, NY
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • UNC Rex Healthcare
      • Rocky Mount, North Carolina, United States, 27804
        • PMG Research of Rocky Mount, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington, LLC
    • Ohio
      • Marion, Ohio, United States, 43302
        • Rama Research LLC
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Columbia Heart Clinic
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Cardiovascular Research
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic, PA
    • Texas
      • Beaumont, Texas, United States, 77701
        • DiscoveResearch, Inc.
      • Houston, Texas, United States, 77025
        • Angiocardiac Care of Texas
      • Sugar Land, Texas, United States, 77478
        • Acacia Medical Research Institute,LLC
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Mary Washington Hospital Research Department
      • Norfolk, Virginia, United States, 23510
        • York Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Of full age of consent (according to local legislation, usually ≥ 18 years) at screening.
  • Male or female patients. Women of child bearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
  • Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial
  • Six minute walk test (6MWT) distance ≤350 m at screening and at baseline.
  • Patients with CHF diagnosed for at least 3 months before Visit 1, and currently in NYHA class II-IV
  • Chronic heart failure (CHF) with preserved Ejection fraction (EF) defined as left ventricle ejection fraction(LVEF) > 40 % as per echocardiography at Visit 1 per local reading and no prior measurement of LVEF ≤ 40% under stable conditions.
  • Elevated N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) > 300 pg/ml for patients without atrial fibrillation (AF), OR > 600 pg/ml for patients with AF, as analysed at the Central laboratory at Visit 1

  • Patients must have at least one of the following evidence of heart failure (HF):

    • Structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) documented by echocardiogram at Visit 1, OR
    • Documented Hospitalization for Heart Failure (HHF) within 12 months prior to Visit 1
  • Consistent with prevailing CV guidelines, if oral diuretics are prescribed to control symptoms, patients must be on an appropriate and stable dose of oral diuretics for at least 2 weeks prior to Visit 1 to control symptoms.
  • Clinically stable at randomization with no signs of heart failure decompensation (as per investigator judgement).

Exclusion Criteria:

  • Myocardial infarction (increase in cardiac enzymes in combination with symptoms of ischaemia or newly developed ischaemic ECG changes), coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or transient ischemic attack in past 90 days prior to Visit 1
  • Acute decompensated HF (exacerbation of CHF) requiring intravenous (i.v.) diuretics, i.v. inotropes or i.v. vasodilators, or left ventricular assist device within 4 weeks prior to Visit 1, and/or during screening period until Visit 2
  • Previous or current randomisation in another Empagliflozin Heart Failure trial (i.e. studies 1245.110, 1245.121, 1245-0168)
  • Type 1 Diabetes Mellitus (T1DM)
  • Impaired renal function, defined as eGFR < 20 mL/min/1.73 m2 (CKD-EPIcr) or requiring dialysis, as determined at Visit 1
  • Symptomatic hypotension or a systolic blood pressure (SBP) < 100 mmHg at Visit 1 or 2
  • SBP ≥ 180 mmHg at Visit 1 or 2, or SBP >160mmHg at both Visit 1 and 2
  • Atrial fibrillation or atrial flutter with a resting heart rate > 110 bpm documented by ECG at Visit 1 (Screening)
  • Unstable angina pectoris in past 30 days prior to Visit 1
  • Largest distance walked in 6 minutes (6MWTD) at baseline <100m.

  • Any presence of condition that precludes exercise testing such as:

    • claudication,
    • uncontrolled (according to investigator judgement) bradyarrhythmia or tachyarrhythmia,
    • significant musculoskeletal disease,
    • primary pulmonary hypertension,
    • severe obesity (body mass index ≥40.0 kg/m2),
    • orthopedic conditions that limit the ability to walk (such as arthritis in the leg, knee or hip injuries)
    • amputation with artificial limb without stable prosthesis function for the past 3 months
    • Any condition that in the opinion of the investigator would contraindicate the assessment of 6MWT
  • Patients in a structured (according to Investigator judgement) exercise training program in the 1 month prior to screening or planned to start one during the course of this trial.
  • ICD implantation within 1 month prior to Visit 1 or planned during the course of the trial
  • Implanted cardiac resynchronisation therapy (CRT)
  • Treatment with i.v. iron therapy or erythropoietin (EPO) within 3 months prior to screening.
  • Further exclusion criteria applies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Empagliflozin
Drug: Empagliflozin
Film-coated tablet
Other Names:
  • JARDIANCE, JARDIANZ, GIBTULIO
Active Comparator: Placebo
Drug: Placebo
Film-coated tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes in Standardised Conditions (6MWTD)
Time Frame: At baseline and at Week 12

Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions (6MWTD). If repeated 6-minutes walk test (6MWT) measurements were available for the same day, the longest distance was used for analysis. Change from baseline was defined as the distance walked in 6 minutes at Week 12 minus the baseline value.

Baseline value was defined as the last available measurement before start of treatment with randomised study medication. If a participant was present at the visit at Week 12 but did not perform the 6MWT, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above.
At baseline and at Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS)
Time Frame: At baseline and at Week 12
Change from baseline in KCCQ-TSS was defined as the endpoint value at week 12 minus the last available measurement before start of treatment with randomised study medication. The KCCQ is 23 item self-administered questionnaire and comprises 7 domains: physical limitation, symptom frequency, symptom burden, symptom stability, social limitation, self-efficacy and quality of life. Additionally 3 summary scores exist: TSS, clinical summary score, and overall summary score. The scores of the KCCQ domains and summary scores range from 0 to 100, with higher score indicating better outcome. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.
At baseline and at Week 12
Change From Baseline to Week 12 in Chronic Heart Failure Questionnaire Self- Administered Standardized Format (CHQ-SAS) Dyspnea Score
Time Frame: At baseline and at Week 12
Change from baseline in CHQ-SAS was defined as the endpoint value at week 12 minus the last available endpoint value before start of treatment with randomised study medication. The CHQ-SAS evaluates 3 domains: dyspnoea, fatigue, and emotional function. Scores of the domains range from 1 to 7, with higher score indicating better quality of life. If no questionnaire was available at week 12, an imputed value was used. Patients with missing week 12 data who had no clinical event were ranked below any patient with non-missing data, but above the patients who had clinical events. Patients who died before week 12 were ranked below the patients in all categories above. If no questionnaire was available at baseline, change from baseline was not imputed.
At baseline and at Week 12
Change From Baseline to Week 6 in Exercise Capacity as Measured by the Distance Walked in 6 Minutes
Time Frame: At baseline and at Week 6

Change from baseline to week 6 in exercise capacity as measured by the distance walked in 6 minutes in standardised conditions. Change from baseline was defined as the distance walked in 6 minutes at Week 6 minus the baseline value. Baseline value was defined as the last available measurement before start of treatment with randomised study medication.

If a participant was present at the visit at Week 6 but did not perform the 6-Minuted Walking Test, the participant was evaluated as having walked a distance of 0 meter. If no value was available for Week 6, an imputed value was used.
At baseline and at Week 6
Change From Baseline in Clinical Congestion Score at Week 12
Time Frame: At baseline and at Week 12
Change from baseline to week 12 in Clinical Congestion score is defined as the score-value at week 12 minus the score-value at baseline. Baseline value was defined as the last available measurement before start of treatment with randomised study medication. The Clinical Congestion Score (summary score) is based on 3 items: orthopnoea, jugular venous distention (JVD) and oedema. Each item was assessed through a 4-measure questionnaire, which was further converted to a standardised 4-point scale ranging from 0 to 3, with 0 indicating no or fewer symptoms and 3 indicating continous or more symptoms. If at least 2 of the 3 items are not missing, the summary score is calculated as: (average over items JVD, orthopnea and oedema actually answered)*3. The summary score ranges from 0 to 9, with lower value indicating better health, and higher value indicating worse health. Mean is adjusted mean.
At baseline and at Week 12
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms at Week 12
Time Frame: At baseline and at Week 12
Change from baseline to week 12 in PGI-S of Heart Failure Symptoms. The Patient Global Impression of Severity (PGI-S) of Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of symptoms severity, specifically: shortness of breath, fatigue and swelling. The PGI-S asks the Patient to choose one response that best describes how his/her heart failure symptoms, specifically: shortness of breath, fatigue and swelling are now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.
At baseline and at Week 12
Change From Baseline in Patient Global Impression of Severity (PGI-S) of Dyspnea Severity at Week 12
Time Frame: At baseline and at Week 12
Change from baseline to week 12 in Patient Global Impression of Severity (PGI-S) of dyspnoea. The PGI-S of Dyspnoea is a 1-item questionnaire designed to assess the participant´s impression of symptom severity, specifically dyspnoea. The PGI-S item asks the participant to choose one response that best describes how his/her dyspnoea is now on a 5-category scale, ranging from 'Not at all' (1) to 'Very severe' (5). Number of participants by change in score are reported. Change in score was defined as the number of categories improved/deteriorated from baseline to week 12.
At baseline and at Week 12
Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms at Week 12
Time Frame: Week 12
The Patient Global Impression of Change (PGI-C) in Heart Failure Symptoms is a 1-item questionnaire to assess the patient's impression of change in heart failure symptoms, specifically: shortness of breath, fatigue, and swelling. The PGI-C asks the patient to choose one Response that best describes the overall change (if any) in his/her heart failure symptoms, specifically: shortness of breath, fatigue, and swelling since he/she started taking the study medication on a 7- category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).
Week 12
Patient Global Impression of Change (PGI-C) in Dyspnea at Week 12
Time Frame: Week 12
The PGI-C in Dyspnoea is a 1-item questionnaire designed to assess the patient's Impression of change in dyspnoea. The PGI-C asks the patient to choose one response that best describes the change (if any) in his/her shortness of breath when performing usual activities since he/she started taking the study medication on a 7-category scale ranging from 'Very much better' (+3) to 'Very much worse' (-3).
Week 12
Relative Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NTproBNP) at Week 12
Time Frame: Within 3 weeks prior to treatment start and at Week 12.
Relative change from baseline to week 12 in N-terminal pro-brain natriuretic peptide (NTproBNP). Relative change from baseline is expressed as ratio of week 12 to baseline. Baseline value was defined as the mean of all available measurements from the screening visit until start of treatment with randomised study medication. Mean is adjusted mean.
Within 3 weeks prior to treatment start and at Week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 4, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1245-0167
  • 2017-004072-59 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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