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Heart Failure With Reduced Ejection FractionPhase 3METEORIC-HFNCT03759392

Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure

A Phase 3 study testing Omecamtiv Mecarbil in people with Heart Failure With Reduced Ejection Fraction, run by Cytokinetics at 81 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Omecamtiv Mecarbil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
81 sitesin 9 countries
Study dates
9 Apr 2019to 6 Jan 2022
Phase
Phase 3
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, greater than or equal to 18 to lesser than or equal to 85 years of age
  • History of chronic HF, defined as requiring continuous treatment with medications for HF for a minimum of 3 months before screening
  • New York Heart Association (NYHA) class II or III at screening
  • Left ventricular ejection fraction less than or equal to 35%
  • On maximally tolerated HF standard of care (SoC) therapies consistent with regional clinical practice guidelines, if not contraindicated and according to investigator judgment of the subject's clinical status. Beta blocker dose must be stable for 30 days prior to randomization.
  • N-terminal (NT)-proBNP level greater than or equal to 200 pg/mL
  • Peak VO2 less than or equal to 75% of the predicted normal value with respiratory exchange ratio (RER) greater than or equal to 1.05 on a screening CPET, confirmed by a CPET core laboratory

Who cannot join

  • Severe uncorrected valvular heart disease
  • Paroxysmal atrial fibrillation or flutter documented within the previous 6 months, direct-current (DC) cardioversion or ablation procedure for atrial fibrillation within 6 months, or plan to attempt to restore sinus rhythm within 6 months of randomization. Subjects with persistent atrial fibrillation and no sinus rhythm documented in the prior 6 months are permitted.
  • Symptomatic bradycardia, second-degree Mobitz type II, or third-degree heart block without a pacemaker.
  • History of gastrointestinal bleeding requiring hospitalization, urgent procedure or transfusion in the prior year, or received intravenous (IV) iron, blood transfusion, or an erythropoiesis-stimulating agent (ESA) within 3 months prior to screening, or planned blood transfusion or ESA use during the study screening or treatment period. Chronic, stable use of oral iron is permitted.
  • Ongoing or planned enrollment in cardiac rehabilitation.
  • Requires assistance to walk or use of mobility assistive devices such as motorized devices, wheelchairs, or walkers. The use of canes for stability while ambulating is acceptable if the subject is deemed capable of performing CPET.
Show all 12Show fewer
  • Major medical event or procedure within 3 months prior to randomization, including: hospitalization, surgery, renal replacement therapy or cardiac procedure. This includes episodes of decompensated HF that require IV HF treatment.
  • At screening: Resting systolic BP greater than 140 mmHg or less than 85 mmHg, or diastolic BP greater than 90 mmHg (mean of triplicate readings); Resting heart rate greater than 90 beats per minute, or less than 50 beats per minute (mean of triplicate readings); Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 (by the modified Modification of Diet in Renal Disease equation); Hepatic impairment defined by a total bilirubin (TBL) greater than or equal to 2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times ULN. Patients with documented Gilbert syndrome and TBL greater than or equal to 2 times ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted.
  • Room air oxygen saturation under 90% at screening
  • Hemoglobin less than 10.0 g/dL at screening
  • Significant adverse finding (e.g., exercise-induced early ischemic changes, abnormal decrease in BP [systolic BP falls by more than 10 mmHg], unexpected arrhythmia or other serious finding) during CPET at screening that precludes safe participation in the study, per investigator
  • Chronotropic incompetence (including inadequate pacemaker rate response) during CPET at screening, defined as a maximum heart rate <60% of the maximum predicted heart rate

Trial locations and contacts

81 sites in 9 countries.

81 sites in 9 countries

United States36 sites

  • Alaska Heart and Vascular Institute

    Anchorage, Alaska, 99508

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital (MGH) - Cardiac Unit Associates

    Boston, Massachusetts, 02114-2621

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • The Ohio State University

    Columbus, Ohio, 43210

  • University of Texas - Southwestern Medical Center

    Dallas, Texas, 75235

  • Baylor Scott and White Heart and Vascular Hospital

    Dallas, Texas, 75246

  • Henry Ford Heart & Vascular Institute

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Cardiovascular Associates Of The Delaware Valley (Cadv), P.A. - Elmer Physicians Care Center - Elmer

    Elmer, New Jersey, 08318

  • Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042

  • Holy Cross Hospital - Fort Lauderdale

    Fort Lauderdale, Florida, 33308-4603

  • Greenville Health System

    Greenville, South Carolina, 29605

  • Hartford Hospital-University of Connecticut School of Medicine

    Hartford, Connecticut, 06102

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania, 17033

  • Community Hospital South, Inc.

    Indianapolis, Indiana, 46227

  • Saint Vincent Medical Group Inc.

    Indianapolis, Indiana, 46260

  • Glacier View Research Institute, Cardiology

    Kalispell, Montana, 59901

  • Saint Luke's Health System

    Kansas City, Missouri, 64111

  • Lancaster Heart And Stroke Foundation

    Lancaster, Pennsylvania, 17603

  • Arkansas Cardiology Clinic

    Little Rock, Arkansas, 72205

  • South Denver Cardiology Associates, PC

    Littleton, Colorado, 80120

  • NYU Langone Medical Center

    New York, New York, 10016

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Broward Research Center - Pembroke Pines

    Pembroke Pines, Florida, 33024

  • McLaren Health Care Corporation

    Petoskey, Michigan, 49770

  • Oregon Health

    Portland, Oregon, 97239

  • Wake Med Health and Hospital

    Raleigh, North Carolina, 27610

  • Queens Heart Institute

    Rosedale, New York, 11422

  • Harbor-UCLA Medical Center

    Torrance, California, 90509

  • St. John Clinical Research Institute

    Tulsa, Oklahoma, 74104

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27101

  • Michigan Heart

    Ypsilanti, Michigan, 48197

Other trials in United States

Netherlands8 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ

  • Onze Lieve Vrouwe Gasthuis (OLVG) Locatie West

    Amsterdam, 1061 AE

  • University Medical Center Groningen

    Groningen, 9713 GZ

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, 2300RC

  • Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)

    Nijmegen, 6500 HB

  • Erasmus MC - Universitair Medisch Centrum Rotterdam

    Rotterdam, South Holland, 3000 CA

  • Universitair Medisch Centrum Utrecht - Wilhelmina Kinderziekenhuis

    Utrecht, 3584 CX

  • Maxima Medisch Centrum Veldhoven

    Veldhoven, 5504 DB

Other trials in Netherlands

France7 sites

  • Centre Hospitalier De La Cote Basque

    Bayonne, 64109

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38028

  • Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon

    La Tronche, 38700

  • Universite De Nantes - L'Institut Du Thorax

    Nantes, 44093

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere

    Paris, 75010

  • Chu de Rouen Hopital Charles Nicolle

    Rouen, 76031

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil

    Toulouse, 31059

Other trials in France

Italy7 sites

  • Azienda Ospedaliera S.Orsola Malpighi

    Bologna, Province Of Bologna, 40138

  • Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia

    Brescia, Province Of Brescia, 25123

  • Ospedali Riuniti Foggia

    Foggia, Apulia, 71100

  • Centro Cardiologico Monzino IRCCS

    Milan, Lombardy, 20138

  • Divisione di Cardiologia con Utic ed Emodinamica

    Naples, 80131

  • Ospedale Monaldi

    Naples, 80131

  • Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana

    Roma, Rome, 00163

Other trials in Italy

Poland7 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

  • Uniwersyteckie Centrum Kliniczne Kliniczne Centrum Kardiologii

    Gdansk, 80-952

  • Oddzial Kliniczny Choroby Wiencowej i Niewydolnosci Serca z Pododdzialem Intensywnego Nadzoru Kardiologicznego

    Krakow, 31- 202

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologiczny

    Lodz, 93-513

  • Centrum Medyczne Medyk Sp z o.o. Sp. k.

    Rzeszów, Podkarpackie Voivodeship, 35-055

  • Instytut Kardiologii Heart Failure Clinic

    Warsaw, 04-628

  • Centrum Chorob Serca, Uniwersytecki Szpital Kllniczny im. Jana Mikulicza Radeckiego we Wrociawiu

    Wroclaw, 50556

Other trials in Poland

Germany6 sites

  • Kerckhoff-Klinik- Bad Nauheim

    Bad Nauheim, 61231

  • Praxisklinik Dresden

    Dresden, 01099

  • Universitaetsklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

    Homburg, 66421

  • Universitaetsklinikum Jena

    Jena, Thuringia, 07747

  • Universitatsklinikum Magdeburg

    Magdeburg, Saxony-Anhalt, 39120

Other trials in Germany

Canada5 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 4Z6

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • Universite de Montreal Institut de Cardiologie de Montreal ICM Montreal Heart Institute MHI

    Montreal, Quebec, H1Y 3N1

  • Mcgill University Health Centre (MUHC)-The Montreal General Hospital (MGH)

    Montreal, Quebec, H3P1E1

Other trials in Canada

Hungary3 sites

  • Balatonfuredi Allami Szivkorhaz

    Balatonfüred, 8230

  • Semmelweis University Heart and Vascular Center

    Budapest, 1122

  • Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)

    Pécs, 7624

Other trials in Hungary

Sweden2 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 413 45

  • Enhet Klinisk forskning, hjartmedicin, Skanes Universitet Sjukhus

    Lund, 22242

Other trials in Sweden

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance

The purpose of this study is to evaluate the effect of treatment with omecamtiv mecarbil compared with placebo on exercise capacity as determined by cardiopulmonary exercise testing following 20 weeks of treatment with omecamtiv mecarbil or placebo

Read the detailed description

Oversight Authorities:

United States: Food and Drug Administration Canada: Health Canada France: National Agency for the Safety of Medicine and Health Products Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy and Nutrition Italy: Italian Medicines Agency Netherlands: Medicines Evaluation Board Poland: Chief Pharmaceutical Inspectorate Sweden: Medical Products Agency

Being tested
Omecamtiv Mecarbil, Placebo

What participants receive

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

  • Omecamtiv MecarbilDrug

    Also called CK-1827452, AMG-423

    Oral omecamtiv mecarbil twice daily for up to 20 weeks with dose level determined by periodic blood testing

  • PlaceboDrug

    Oral placebo twice daily for up to 20 weeks

Study groups in NCT03759392
Study groupRoleWhat they receive
Omecamtiv MecarbilExperimentalOmecamtiv mecarbil was administered as an oral modified-release tablet twice daily for up to 20 weeks. Participants randomized to this arm started at an omecamtiv mecarbil dose of 25 mg twice daily. The dose could be increased based on plasma concentrations at Weeks 2 and 6.
Receives: Drug: Omecamtiv Mecarbil
PlaceboPlacebo comparatorParticipants randomized this arm received placebo tablets (matching the appearance of the omecamtiv mecarbil tablets) twice daily for up to 20 weeks.
Receives: Drug: Placebo

What is being measured

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

  1. Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20

    The effect of treatment on exercise capacity, as assessed by peak oxygen uptake, was assessed during cardiopulmonary exercise testing (CPET) with gas-exchange analysis. Cycle ergometry was the preferred modality for exercise testing; treadmill exercise testing was an acceptable alternative. Participants were to use the same testing modality for all exercise tests during the study. Whenever possible, CPET was administered by the same study personnel using the same equipment throughout the study.

    Measured: Baseline and Week 20

Secondary outcomes (3)

  1. Change in Total Workload During Cardiopulmonary Exercise Testing From Baseline to Week 20

    Total workload was measured during CPET (cycle ergometry [preferred] or treadmill exercise testing) and represents the maximum load to which a participant was subjected during CPET in order to produce work.

    Measured: Baseline and Week 20

  2. Change in Ventilatory Efficiency During Cardiopulmonary Exercise Testing From Baseline to Week 20

    Ventilatory efficiency (ventilation [VE]/volume of exhaled carbon dioxide [VCO2]) was measured through CPET with gas exchange analysis.

    Measured: Baseline and Week 20

  3. Change in the Average Daily Activity Units Measured Over a 2-week Period From Baseline (Week -2 to Day 1) to Weeks 18-20

    The effect of treatment on daily activity, as assessed by average daily activity units, was evaluated by actigraphy. Actigraphy was collected during 4 sessions throughout the study for 2 week intervals.

    Measured: Baseline (Week -2 to Day 1) to Weeks 18-20

Timeline

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

  1. First posted30 Nov 2018
  2. Study start9 Apr 2019
  3. Primary completion8 Nov 2021
  4. Study completion6 Jan 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03759392
Sponsor's protocol ID
CY 1031
Other IDs
2018-001233-40, 2018
Acronym
METEORIC-HF
Status last verified
Feb 2023
First submitted
15 Nov 2018
Last updated
7 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • Lewis GD, Voors AA, Cohen-Solal A, Metra M, Whellan DJ, Ezekowitz JA, Bohm M, Teerlink JR, Docherty KF, Lopes RD, Divanji PH, Heitner SB, Kupfer S, Malik FI, Meng L, Wohltman A, Felker GM. Effect of Omecamtiv Mecarbil on Exercise Capacity in Chronic Heart Failure With Reduced Ejection Fraction: The METEORIC-HF Randomized Clinical Trial. JAMA. 2022 Jul 19;328(3):259-269. doi: 10.1001/jama.2022.11016.

    PubMed 35852527

  • Lewis GD, Docherty KF, Voors AA, Cohen-Solal A, Metra M, Whellan DJ, Ezekowitz JA, Ponikowski P, Bohm M, Teerlink JR, Heitner SB, Kupfer S, Malik FI, Meng L, Felker GM. Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF. Circ Heart Fail. 2022 May;15(5):e008970. doi: 10.1161/CIRCHEARTFAILURE.121.008970. Epub 2022 Mar 3.

    PubMed 35236099

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omecamtiv Mecarbil in people with Heart Failure With Reduced Ejection Fraction, run by Cytokinetics at 81 sites in 9 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 12 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 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 81 sites in United States, Netherlands, France, Italy, Poland and 4 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.

What does this phase mean?

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?

Yes. Results are posted in the registry (first posted 7 Mar 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?

Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20 (time frame: Baseline and Week 20). 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 NCT03759392, 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 7 Mar 2023.

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