Heart Failure Clinical Trial

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

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

View Full Description

Full 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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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.
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

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

276

Study ID:

NCT03759392

Recruitment Status:

Completed

Sponsor:

Cytokinetics

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 80 Locations for this study

See Locations Near You

Alaska Heart and Vascular Institute
Anchorage Alaska, 99508, United States
Arkansas Cardiology Clinic
Little Rock Arkansas, 72205, United States
Harbor-UCLA Medical Center
Torrance California, 90509, United States
South Denver Cardiology Associates, PC
Littleton Colorado, 80120, United States
Hartford Hospital-University of Connecticut School of Medicine
Hartford Connecticut, 06102, United States
Holy Cross Hospital - Fort Lauderdale
Fort Lauderdale Florida, 33308, United States
Broward Research Center - Pembroke Pines
Pembroke Pines Florida, 33024, United States
Emory University
Atlanta Georgia, 30322, United States
Community Hospital South, Inc.
Indianapolis Indiana, 46227, United States
Saint Vincent Medical Group Inc.
Indianapolis Indiana, 46260, United States
University of Maryland
Baltimore Maryland, 21201, United States
Massachusetts General Hospital (MGH) - Cardiac Unit Associates
Boston Massachusetts, 02114, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Henry Ford Heart & Vascular Institute
Detroit Michigan, 48202, United States
McLaren Health Care Corporation
Petoskey Michigan, 49770, United States
Michigan Heart
Ypsilanti Michigan, 48197, United States
Saint Luke's Health System
Kansas City Missouri, 64111, United States
Glacier View Research Institute, Cardiology
Kalispell Montana, 59901, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Cardiovascular Associates Of The Delaware Valley (Cadv), P.A. - Elmer Physicians Care Center - Elmer
Elmer New Jersey, 08318, United States
Newark Beth Israel Medical Center
Newark New Jersey, 07112, United States
NYU Langone Medical Center
New York New York, 10016, United States
Queens Heart Institute
Rosedale New York, 11422, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Med Health and Hospital
Raleigh North Carolina, 27610, United States
Wake Forest University School of Medicine
Winston-Salem North Carolina, 27101, United States
The Ohio State University
Columbus Ohio, 43210, United States
St. John Clinical Research Institute
Tulsa Oklahoma, 74104, United States
Oregon Health
Portland Oregon, 97239, United States
Capital Area Research, LLC
Camp Hill Pennsylvania, 17011, United States
Penn State Hershey Children's Hospital
Hershey Pennsylvania, 17033, United States
Lancaster Heart And Stroke Foundation
Lancaster Pennsylvania, 17603, United States
Greenville Health System
Greenville South Carolina, 29605, United States
University of Texas - Southwestern Medical Center
Dallas Texas, 75235, United States
Baylor Scott and White Heart and Vascular Hospital
Dallas Texas, 75246, United States
Inova Heart and Vascular Institute
Falls Church Virginia, 22042, United States
Foothills Medical Centre
Calgary Alberta, T2N 4, Canada
London Health Sciences Centre - University Hospital
London Ontario, N6A 5, Canada
Ecogene-21
Chicoutimi Quebec, G7H 7, Canada
Universite de Montreal Institut de Cardiologie de Montreal ICM Montreal Heart Institute MHI
Montreal Quebec, H1Y 3, Canada
Mcgill University Health Centre (MUHC)-The Montreal General Hospital (MGH)
Montreal Quebec, H3P1E, Canada
Centre Hospitalier De La Cote Basque
Bayonne cedex , 64109, France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble , 38028, France
Centre Hospitalier Universitaire de Grenoble-Hopital Albert Michallon
La Tronche , 38700, France
Universite De Nantes - L'Institut Du Thorax
Nantes CEDEX 1 , 44093, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
Paris , 75010, France
Chu de Rouen Hopital Charles Nicolle
Rouen Cedex , 76031, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
Toulouse Cedex 9 , 31059, France
Universitaetsklinik Heidelberg
Heidelberg Baden-wurttemberg, 69120, Germany
Universitatsklinikum Magdeburg
Magdeburg Saxony-Anhalt, 39120, Germany
Universitaetsklinikum Jena
Jena Thueringen, 07747, Germany
Kerckhoff-Klinik- Bad Nauheim
Bad Nauheim , 61231, Germany
Praxisklinik Dresden
Dresden , 01099, Germany
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg , 66421, Germany
Balatonfuredi Allami Szivkorhaz
Balatonfured , 8230, Hungary
Semmelweis University Heart and Vascular Center
Budapest , 1122, Hungary
Pecsi Tudomanyegyetem (PTE) Altalanos Orvostudomanyi Kar (AOK) (University of Pecs Medical School)
Pecs , 7624, Hungary
Ospedali Riuniti Foggia
Foggia Apulia, 71100, Italy
Centro Cardiologico Monzino IRCCS
Milano Lombardia, 20138, Italy
Azienda Ospedaliera S.Orsola Malpighi
Bologna Province Of Bologna, 40138, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Universita degli Studi Di Brescia
Brescia Province Of Brescia, 25123, Italy
Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana
Roma Rome, 00163, Italy
Divisione di Cardiologia con Utic ed Emodinamica
Napoli , 80131, Italy
Ospedale Monaldi
Napoli , 80131, Italy
Erasmus MC - Universitair Medisch Centrum Rotterdam
Rotterdam South Holland, 3000 , Netherlands
Jeroen Bosch Ziekenhuis
'S-Hertogenbosch , 5223 , Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG) Locatie West
Amsterdam , 1061 , Netherlands
University Medical Center Groningen
Groningen , 9713 , Netherlands
Leids Universitair Medisch Centrum (LUMC)
Leiden , 2300R, Netherlands
Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)
Nijmegen , 6500 , Netherlands
Universitair Medisch Centrum Utrecht - Wilhelmina Kinderziekenhuis
Utrecht , 3584 , Netherlands
Maxima Medisch Centrum Veldhoven
Veldhoven , 5504 , Netherlands
Centrum Medyczne Medyk Sp z o.o. Sp. k.
Rzeszow Podkarpackie, 35-05, Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok , 15-27, Poland
Uniwersyteckie Centrum Kliniczne Kliniczne Centrum Kardiologii
Gdansk , 80-95, Poland
Oddzial Kliniczny Choroby Wiencowej i Niewydolnosci Serca z Pododdzialem Intensywnego Nadzoru Kardiologicznego
Krakow , 31- 2, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Oddzial Kardiologiczny
Lodz , 93-51, Poland
Instytut Kardiologii Heart Failure Clinic
Warsaw , 04-62, Poland
Centrum Chorob Serca, Uniwersytecki Szpital Kllniczny im. Jana Mikulicza Radeckiego we Wrociawiu
Wroclaw , 50556, Poland
Sahlgrenska Universitetssjukhuset
Göteborg , 413 4, Sweden
Enhet Klinisk forskning, hjartmedicin, Skanes Universitet Sjukhus
Lund , 22242, Sweden

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 3

Estimated Enrollment:

276

Study ID:

NCT03759392

Recruitment Status:

Completed

Sponsor:


Cytokinetics

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.