Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Interventions
- Drug: Placebo
- Registration Number
- NCT03759392
- Lead Sponsor
- Cytokinetics
- Brief 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Omecamtiv Mecarbil Omecamtiv Mecarbil Omecamtiv 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. Placebo Placebo Participants randomized this arm received placebo tablets (matching the appearance of the omecamtiv mecarbil tablets) twice daily for up to 20 weeks.
- Primary Outcome Measures
Name Time Method Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20 Baseline and 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.
- Secondary Outcome Measures
Name Time Method Change in Total Workload During Cardiopulmonary Exercise Testing From Baseline to Week 20 Baseline and 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.
Change in Ventilatory Efficiency During Cardiopulmonary Exercise Testing From Baseline to Week 20 Baseline and Week 20 Ventilatory efficiency (ventilation \[VE\]/volume of exhaled carbon dioxide \[VCO2\]) was measured through CPET with gas exchange analysis.
Change in the Average Daily Activity Units Measured Over a 2-week Period From Baseline (Week -2 to Day 1) to Weeks 18-20 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.
Trial Locations
- Locations (81)
Alaska Heart and Vascular Institute
🇺🇸Anchorage, Alaska, United States
Glacier View Research Institute, Cardiology
🇺🇸Kalispell, Montana, United States
Mcgill University Health Centre (MUHC)-The Montreal General Hospital (MGH)
🇨🇦Montreal, Quebec, Canada
Kerckhoff-Klinik- Bad Nauheim
🇩🇪Bad Nauheim, Germany
Universitatsklinikum Magdeburg
🇩🇪Magdeburg, Saxony-Anhalt, Germany
Centro Cardiologico Monzino IRCCS
🇮🇹Milano, Lombardia, Italy
Balatonfuredi Allami Szivkorhaz
ðŸ‡ðŸ‡ºBalatonfured, Hungary
Michigan Heart
🇺🇸Ypsilanti, Michigan, United States
Holy Cross Hospital - Fort Lauderdale
🇺🇸Fort Lauderdale, Florida, United States
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
Azienda Ospedaliera S.Orsola Malpighi
🇮🇹Bologna, Province Of Bologna, Italy
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
NYU Langone Medical Center
🇺🇸New York, New York, United States
Queens Heart Institute
🇺🇸Rosedale, New York, United States
Inova Heart and Vascular Institute
🇺🇸Falls Church, Virginia, United States
Centre Hospitalier De La Cote Basque
🇫🇷Bayonne cedex, France
Praxisklinik Dresden
🇩🇪Dresden, Germany
University of Texas - Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Jeroen Bosch Ziekenhuis
🇳🇱'S-Hertogenbosch, Netherlands
Groupe Hospitalier Mutualiste de Grenoble
🇫🇷Grenoble, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
🇫🇷Toulouse Cedex 9, France
Wake Med Health and Hospital
🇺🇸Raleigh, North Carolina, United States
Universite de Montreal Institut de Cardiologie de Montreal ICM Montreal Heart Institute MHI
🇨🇦Montreal, Quebec, Canada
Penn State Hershey Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
Ospedali Riuniti Foggia
🇮🇹Foggia, Apulia, Italy
Semmelweis University Heart and Vascular Center
ðŸ‡ðŸ‡ºBudapest, Hungary
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Universitair Medisch Centrum Utrecht - Wilhelmina Kinderziekenhuis
🇳🇱Utrecht, Netherlands
Instytut Kardiologii Heart Failure Clinic
🇵🇱Warsaw, Poland
University of Maryland
🇺🇸Baltimore, Maryland, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Massachusetts General Hospital (MGH) - Cardiac Unit Associates
🇺🇸Boston, Massachusetts, United States
Saint Vincent Medical Group Inc.
🇺🇸Indianapolis, Indiana, United States
Onze Lieve Vrouwe Gasthuis (OLVG) Locatie West
🇳🇱Amsterdam, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Leids Universitair Medisch Centrum (LUMC)
🇳🇱Leiden, Netherlands
Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)
🇳🇱Nijmegen, Netherlands
The Ohio State University
🇺🇸Columbus, Ohio, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Ospedale Monaldi
🇮🇹Napoli, Italy
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
South Denver Cardiology Associates, PC
🇺🇸Littleton, Colorado, United States
Hartford Hospital-University of Connecticut School of Medicine
🇺🇸Hartford, Connecticut, United States
Broward Research Center - Pembroke Pines
🇺🇸Pembroke Pines, Florida, United States
Community Hospital South, Inc.
🇺🇸Indianapolis, Indiana, United States
McLaren Health Care Corporation
🇺🇸Petoskey, Michigan, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
St. John Clinical Research Institute
🇺🇸Tulsa, Oklahoma, United States
Lancaster Heart And Stroke Foundation
🇺🇸Lancaster, Pennsylvania, United States
London Health Sciences Centre - University Hospital
🇨🇦London, Ontario, Canada
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
🇫🇷Paris, France
Universite De Nantes - L'Institut Du Thorax
🇫🇷Nantes CEDEX 1, France
Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)
ðŸ‡ðŸ‡ºPecs, Hungary
Divisione di Cardiologia con Utic ed Emodinamica
🇮🇹Napoli, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
🇮🇹Brescia, Province Of Brescia, Italy
Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana
🇮🇹Roma, Rome, Italy
Erasmus MC - Universitair Medisch Centrum Rotterdam
🇳🇱Rotterdam, South Holland, Netherlands
Centrum Medyczne Medyk Sp z o.o. Sp. k.
🇵🇱Rzeszow, Podkarpackie, Poland
Maxima Medisch Centrum Veldhoven
🇳🇱Veldhoven, Netherlands
Oddzial Kliniczny Choroby Wiencowej i Niewydolnosci Serca z Pododdzialem Intensywnego Nadzoru Kardiologicznego
🇵🇱Krakow, Poland
Uniwersyteckie Centrum Kliniczne Kliniczne Centrum Kardiologii
🇵🇱Gdansk, Poland
Centrum Chorob Serca, Uniwersytecki Szpital Kllniczny im. Jana Mikulicza Radeckiego we Wrociawiu
🇵🇱Wroclaw, Poland
Enhet Klinisk forskning, hjartmedicin, Skanes Universitet Sjukhus
🇸🇪Lund, Sweden
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologiczny
🇵🇱Lodz, Poland
Sahlgrenska Universitetssjukhuset
🇸🇪Göteborg, Sweden
Capital Area Research, LLC
🇺🇸Camp Hill, Pennsylvania, United States
Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon
🇫🇷La Tronche, France
Saint Luke's Health System
🇺🇸Kansas City, Missouri, United States
Cardiovascular Associates Of The Delaware Valley (Cadv), P.A. - Elmer Physicians Care Center - Elmer
🇺🇸Elmer, New Jersey, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Universitaetsklinik Heidelberg
🇩🇪Heidelberg, Baden-wurttemberg, Germany
Baylor Scott and White Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Chu de Rouen Hopital Charles Nicolle
🇫🇷Rouen Cedex, France
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
🇩🇪Homburg, Germany
Universitaetsklinikum Jena
🇩🇪Jena, Thueringen, Germany
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Heart & Vascular Institute
🇺🇸Detroit, Michigan, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health
🇺🇸Portland, Oregon, United States
Arkansas Cardiology Clinic
🇺🇸Little Rock, Arkansas, United States