--- title: "Heart Failure COMET-HF | Sutter Health" description: "A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)" url: "https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118" --- 1. [Home](https://www.sutterhealth.org/) / 2. [Research](https://www.sutterhealth.org/research) / 3. [Clinical trials](https://www.sutterhealth.org/research/clinical-trials) / 4. Heart Failure COMET-HF # Heart Failure COMET-HF **Status:** Open to Enrollment [Email us to enroll](https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118#enroll) #### Study details View study details on [www.clinicaltrials.gov](https://www.clinicaltrials.gov/study/NCT06736574). #### Locations - Sacramento - San Francisco #### Clinical trial FAQs Information for patients and study volunteers, including [frequently asked questions](https://www.sutterhealth.org/research/faqs). The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction. Detailed Description This study is designed to evaluate the efficacy and safety of omecamtiv mecarbil in reducing the risk of the primary composite endpoint of cardiovascular (CV) death, first heart failure (HF) event, left ventricular assist device (LVAD) implantation, cardiac transplantation, and stroke in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF). Eligible patients will be randomized 1:1 to investigational product (IP) - omecamtiv mecarbil or placebo. The study is event-driven and will conclude when at least 850 participants experience a HF event or CV death, whichever comes first. An interim analysis for futility and efficacy based on the primary composite endpoint is planned when approximately 570 (67%) of the planned 850 first HF events or CV deaths are observed. Estimated duration of participation: Up to 3 years. ![Michael X Pham, M.D., FACC, MPH](https://dyn.mktgcdn.com/p/iIwLxwPIni-bp06y2cNz-RSMZWnemxRKKmJhrSJag2M/fit=crop,gravity=auto,dpr=2,width=188,height=250,quality=100) Michael X Pham, M.D., FACC, MPH Principal investigator [View profile](https://www.sutterhealth.org/research/investigators/michael-x-pham-md-facc-mph-1049681228) ![Nancy Luo, M.D., MHS, FACC](https://dyn.mktgcdn.com/p/bJHbuIW1FjTw8imMnUJx_hk5xKZ5tGE_lQKGgEdlze8/fit=crop,gravity=auto,dpr=2,width=188,height=250,quality=100) Nancy Luo, M.D., MHS, FACC Principal investigator [View profile](https://www.sutterhealth.org/research/investigators/nancy-luo-md-mhs-facc-2022477501) ## Sub-Investigators [Ranjan Ray, M.D., Ph.D.](https://www.sutterhealth.org/research/investigators/ranjan-ray-md-phd-1078064881) , [Jared J Herr, M.D.](https://www.sutterhealth.org/research/investigators/jared-j-herr-md-1049681058) , [Yu Xie, M.D.](https://www.sutterhealth.org/research/investigators/yu-xie-md-1078064889) , [Gurpreet S Sodhi, M.D.](https://www.sutterhealth.org/research/investigators/gurpreet-s-sodhi-md-1049681244) , [Michael A Gibson, M.D.](https://www.sutterhealth.org/research/investigators/michael-a-gibson-md-1097247582) , [Zijian Xu, M.D., Ph.D., FACC](https://www.sutterhealth.org/research/investigators/zijian-xu-md-phd-facc-1049681028) ## Email us to enroll - [Email Sacramento](mailto:ClinicalResearch%40sutterhealth.org?subject=More%20information%20on%20Heart%20Failure%20COMET-HF%20in%20Sacramento&body=Please%20be%20aware%20that%20if%20you%20reply%20with%20unencrypted%20email%2C%20this%20increases%20the%20risk%20that%20information%20could%20be%20read%20by%20an%20unauthorized%20third%20party.%20Please%20do%20not%20include%20any%20Protected%20Health%20Information%20in%20your%20email%20response.) - [Email San Francisco](mailto:ClinicalResearch%40sutterhealth.org?subject=More%20information%20on%20Heart%20Failure%20COMET-HF%20in%20San%20Francisco&body=Please%20be%20aware%20that%20if%20you%20reply%20with%20unencrypted%20email%2C%20this%20increases%20the%20risk%20that%20information%20could%20be%20read%20by%20an%20unauthorized%20third%20party.%20Please%20do%20not%20include%20any%20Protected%20Health%20Information%20in%20your%20email%20response.) ## Related clinical trials [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) - Clinical trial ### [Heart Failure - TEAM-HF](https://www.sutterhealth.org/research/clinical-trials/advancing-heart-failure-team-hf-1097247574) Trial to Evaluate Safety and Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure **Status:** Open to Enrollment - Clinical trial ### [Heart Failure CONFIRMATION-HF](https://www.sutterhealth.org/research/clinical-trials/heart-failure-confirmation-hf-1095250414) Combined Efficacy and Safety of an Early, Intensive, Management Strategy with Finerenone and SGLT2 Inhibitor in Patients Hospitalized with Heart Failure (CONFIRMATION-HF) **Status:** Open to Enrollment - Clinical trial ### [Heart Failure FINALITY-HF](https://www.sutterhealth.org/research/clinical-trials/heart-failure-finality-hf-2005599814) A Randomized, Double-blind, Placebo-controlled Pragmatic Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure and Reduced Ejection Fraction Who Are Intolerant of or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF) **Status:** Open to Enrollment - Clinical trial ### [Heart Failure REDEFINE-HF](https://www.sutterhealth.org/research/clinical-trials/heart-failure-redefine-hf-1095250384) Randomized Trial to Determine the Efficacy and Safety of Finerenone on Morbidity and Mortality Among Heart Failure Patients With Left Ventricular Ejection Fraction Greater Than or Equal to 40% Hospitalized Due to an Episode of Acute Decompensated Heart Failure (REDEFINE-HF) **Status:** Open to Enrollment - Clinical trial ### [Heart Failure AIM HIGHer Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System CA\_CP\_340](https://www.sutterhealth.org/research/clinical-trials/heart-failure-aim-higher-cardiac-contractility-modulation-therapy-via-optimizer-smart-mini-system-ca_cp_340-2077445142) Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction **Status:** Open to Enrollment [View all clinical trials](https://www.sutterhealth.org/research-search-results?verticalKey=clinical_trial) ```json {"@context":"https://schema.org","@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org","logo":"https://www.sutterhealth.org/static/images/sutter-health-logo.svg","address":{"@type":"PostalAddress","streetAddress":"2200 River Plaza Drive","addressLocality":"Sacramento","addressRegion":"CA","postalCode":"95833","addressCountry":"US"},"areaServed":{"@type":"AdministrativeArea","name":"California"},"sameAs":["https://www.facebook.com/SutterHealth","https://www.instagram.com/sutterhealth/","https://x.com/SutterHealth","https://www.youtube.com/sutterhealth","https://www.linkedin.com/company/sutter-health","https://en.wikipedia.org/wiki/Sutter_Health"]} ``` ```json {"@context":"https://schema.org","@type":"BreadcrumbList","@id":"https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118#breadcrumblist","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https://www.sutterhealth.org/"},{"@type":"ListItem","position":2,"name":"Research","item":"https://www.sutterhealth.org/research"},{"@type":"ListItem","position":3,"name":"Clinical trials","item":"https://www.sutterhealth.org/research/clinical-trials"},{"@type":"ListItem","position":4,"name":"Heart Failure COMET-HF"}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalWebPage","@id":"https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118#medicalwebpage","name":"Heart Failure COMET-HF","description":"A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)","url":"https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118","inLanguage":"en-US","dateModified":"2026-05-21","publisher":{"@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org"},"medicalAudience":{"@type":"MedicalAudience","audienceType":"Patient"},"mainEntity":{"@id":"https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118#medicaltrial"},"breadcrumb":{"@id":"https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118#breadcrumblist"},"mentions":[{"@type":"Person","name":"Michael X Pham, M.D., FACC, MPH","url":"https://www.sutterhealth.org/research/investigators/michael-x-pham-md-facc-mph-1049681228","jobTitle":"Principal Investigator","affiliation":{"@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org"}},{"@type":"Person","name":"Nancy Luo, M.D., MHS, FACC","url":"https://www.sutterhealth.org/research/investigators/nancy-luo-md-mhs-facc-2022477501","jobTitle":"Principal Investigator","affiliation":{"@type":"MedicalOrganization","name":"Sutter Health","@id":"https://www.sutterhealth.org/#medicalorganization","url":"https://www.sutterhealth.org"}}]} ``` ```json {"@context":"https://schema.org","@type":"MedicalTrial","@id":"https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118#medicaltrial","name":"Heart Failure COMET-HF","alternateName":"A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients With Symptomatic Heart Failure With Severely Reduced Ejection Fraction (COMET-HF)","url":"https://www.sutterhealth.org/research/clinical-trials/heart-failure-comet-hf-2015330118","description":"The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction. 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