Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06200207
Other study ID # NN6018-4914
Secondary ID U1111-1293-75162
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2024
Est. completion date August 17, 2026

Study information

Verified date May 2024
Source Novo Nordisk A/S
Contact Novo Nordisk
Phone (+1) 866-867-7178
Email clinicaltrials@novonordisk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is being done to see if ziltivekimab can be used to treat participants living with heart failure and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (inactive substance that looks like the study medicine but does not contain any medicine). The treatment participants get is decided by chance. Participant's chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine that doctors cannot prescribe. The study is expected to last for up to 1 year and 4 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 680
Est. completion date August 17, 2026
Est. primary completion date May 13, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Serum high-sensitivity C-reactive protein (hs-CRP) greater than or equal to 2 milligrams per liter (mg/L) at screening (visit 1) - Disease specific - cardiovascular: - N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than or equal to 225 picograms per milliliter (pg/mL) (375 pg/mL for participants with atrial fibrillation/flutter) at screening - Diagnosis of heart failure (New York heart association (NYHA) Class II-III) - Left ventricular ejection fraction (LVEF) greater than 40 percent documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (example myocardial infarction (MI) or heart failure (HF) hospitalisation) - Structural heart disease and/or functional heart disease documented by echocardiography within 12 months prior to or at screening (visit 1) showing at least one of the following: 1. Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m^2) 2. LA diameter greater than or equal to 3.8 centimeter (cm) 3. LA length greater than or equal to 5.0 cm 4. LA area greater than or equal to 20 square centimeter (cm^2) 5. LA volume greater than or equal to 55 milliliter (mL) 6. Intraventricular septal thickness greater than or equal to 1.1 cm 7. Posterior wall thickness greater than or equal to 1.1 cm 8. LV mass index greater than or equal to 115 gram per square meter (g/m^2) in men or greater than or equal to 95 g/m^2 in women h) E/e' (mean septal and lateral) greater than or equal to 10 i) e' (mean septal and lateral) less than 9 centimeter per second (cm/s) - No heart failure hospitalisations or urgent heart failure visits between screening and randomisation - Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres - Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening Exclusion Criteria: - Medical conditions - cardiovascular: - Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1) - Systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) at screening (visit 1). If the systolic blood pressure is 160-179 mmHg, the patient should be receiving greater than or equal to 3 antihypertensive drugs - Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1) - Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1) - Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1) - Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical procedure planned at the time of randomisation (visit 2) - Heart failure due to infiltrative cardiomyopathy (e.g., sarcoid, amyloid), arrhythmogenic right ventricular cardiomyopathy, Takutsubo cardiomyopathy, genetic hypertrophic cardiomyopathy or obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, uncorrected more than moderate primary valve disease - Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD) - Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism) - Medical conditions - infections/immunosuppression: - Clinical evidence of, or suspicion of, active infection at the discretion of the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ziltivekimab
Zilitivekimab will be administered subcutaneously once-monthly.
Placebo
Placebo matched to ziltivekimab will be administered subcutaneously once-monthly.

Locations

Country Name City State
Argentina Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli Buenos Aires
Argentina Instituto de Investigaciones Clinicas Quilmes SRL Buenos Aires
Argentina Centro de Investigación y Prevención Cardiovascular Caba
Argentina Centro Médico CIMEL Lanus Este Buenos Aires
Argentina Consultorio Integral de Atención al Diabético Morón
Argentina Centro Cardiovascular Salta Salta
Argentina Investigaciones Clinicas Tucuman San Miguel De Tucumán, Tucumán.
Australia Ballarat Base Hospital Ballarat Victoria
Australia The Prince Charles Hospital Brisbane Queensland
Australia The Prince Charles Hospital Brisbane Queensland
Australia The Cardiologists Pty Ltd Epping Victoria
Australia The Cardiologists Pty Ltd Epping Victoria
Australia Fiona Stanley Hospital Cardiology Murdoch Western Australia
Australia John Hunter Hospital New Lambton Heights New South Wales
Australia John Hunter Hospital New Lambton Heights New South Wales
Australia Illawarra Heart Health Centre Wollongong New South Wales
Bulgaria MHAT Haskovo AD Haskovo
Bulgaria UMHAT Heart and Brain Pleven
Bulgaria "UMHAT "Sveti Georgi" EAD Plovdiv
Bulgaria "Medical Center Hera" EOOD - Sofia Sofia
Bulgaria "UMHAT "Sveta Anna" Sofia" AD, Clinic of Cardiology Sofia
Bulgaria "UMHATEM N.I. Pirogov" EAD Sofia
Bulgaria Medico-dental center ISUL - Tsaritsa Yoanna EOOD Sofia
Canada University of Calgary_Calgary Calgary Alberta
Canada Cambridge Cardiac Care Centre Cambridge Ontario
Canada Saul Vizel Pro. Med. Corp Cambridge Ontario
Canada Institut de Cardiologie de Montreal Montreal Quebec
Canada Montreal General Hospital Montreal Quebec
Canada CHU de Quebec-Uni Laval-Hotel Quebec
Canada Corcare Cardiovascular Research Scarborough Ontario
Canada Diabetes Heart Research Centre Toronto Ontario
Canada Clinical Research Solutions Inc. Waterloo Ontario
Canada CPS Research Waterloo Ontario
Czechia Kardiologicka ambulance Brno s.r.o. Brno
Czechia Vojenska nemocnice Brno Brno
Czechia Poliklinika Holešovice VISIONARY - MEDICON a.s. Praha 7
Czechia Svitavska nemocnice Kardiologie Svitavy
Czechia Kardiologie Trutnov Ferkl Trutnov
France Centre Hospitalier Regional Universitaire de Tours-Hopital Trousseau Chambray Les Tours
France Centre Hospitalier Universitaire de Poitiers Poitiers
France Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes
France Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle Rouen cedex
France Centre Hospitalier Intercommunal Toulon La Seine-Sur-Mer - Hopital Sainte Musse Toulon
France Chru de Nancy - Hopital Brabois Vandoeuvre Les Nancy
Germany Herzzentrum Dresden GmbH Universitätsklinik Dresden
Germany Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda
Germany MVZ CCB Frankfurt Und Main-Taunus GbR Frankfurt
Germany Medical Center - University Of Freiburg Freiburg
Germany UKS - Innere Medizin III Homburg
Germany Kardiopraxis Schirmer Kaiserslautern
Greece "Hygeia" General Hospital of Athens Athens
Greece 'G. Gennimatas' General Hospital of Athens Athens
Greece Alexandra General Hospital, Therapeutic Clinic Athens Attiki
Greece Evangelismos Hospital Athens
Greece Konstantopouleio G.H. of Athens, "Agia Olga" Athens
Greece U.G.H of Athens "Attikon" Chaidari, Athens
Greece General Hospital of Chios "Skilitsio" Chios
Greece Univ Gen Hospital Larisa, Cardiology Medicine Clinic Larissa
Greece Sismanogleio General Hospital Marousi
Greece "AHEPA" University General Hospital of Thessaloniki Thessaloniki
Greece 'Ippokrateio' General Hospital of Thessaloniki Thessaloniki
Greece Gen Hospital of Thessaloniki G.Papanikolaou,Cardiology Dpt Thessaloniki
India KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre Belagavi Karnataka
India Sri Jayadeva Institute of Cardiovascular Sciences & Research Bengaluru Karnataka
India St John's Medical College Hospital Bengaluru Karnataka
India All India Institute of Medical Sciences (AIIMS), Bhubaneswar Bhubaneswar Odisha
India Jawaharlal Nehru Medical College and Hospital Bikaner Rajasthan
India S.P. Medical College & Associated Group of Hospitals Bikaner Rajasthan
India Guru Nanak CARE Hospitals Hyderabad Telangana
India Malla Reddy Narayana Multispeciality Hospital Hyderabad Telangana
India Ganesh Shankar Vidyarthe Memorial Medical College (GSVM Medical College) Kanpur Uttar Pradesh
India B M Birla Heart Research Centre Kolkata West Bengal
India Dr. Ram Manohar Lohia Institute of Medical Sciences Lucknow Uttar Pradesh
India Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh
India Manipal Hospital, Mysuru Mysuru Karnataka
India All India Institute of Medical Sciences (AIIMS), Nagpur Nagpur Maharashtra
India Sengupta Hospital and Research Institute Nagpur Maharashtra
India Chopda Medicare and Research Centre Pvt. Ltd. Nashik Maharashtra
India Vijan Hospital & Research Centre Nashik Maharashtra
India Vijan Hospital & Research Centre Nashik Maharashtra
India All India Institute of Medical Sciences (AIIMS) New Delhi Delhi
India G B Pant Institute of Postgraduate Medical Education and Research New Delhi Delhi
India Rajiv Gandhi Super Speciality Hospital New Delhi Delhi
India Sir Ganga Ram Hospital New Delhi Delhi
India Vardhaman Mahavir Medical College & Safdarjung Hospital New Delhi Delhi
India Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) Puducherry
India Villoo Poonawalla Memorial Hospital Pune Maharashtra
India Kasturba Medical College and Hospital, Manipal Udupi Karnataka
India Rhythm Heart Institute Vadodara Gujarat
India Siddhartha Medical College & Government General Hospital Vijaywada Andhra Pradesh
India King George Hospital Visakhapatnam Andra Pradesh
Malaysia Hospital Sultanah Bahiyah Alor Setar Kedah
Malaysia Hospital Raja Permaisuri Bainun Ipoh Ipoh Perak
Malaysia Hospital Sultanah Aminah Johor Bahru Johor
Malaysia Hospital Serdang Kajang
Malaysia Hospital Raja Perempuan Zainab II Kota Bharu, Kelantan
Malaysia University Malaya Medical Centre Kuala Lumpur Wilayah Persekutuan Kuala Lumpur
Malaysia Hospital Tengku Ampuan Afzan Kuantan Pahang
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku Bialystok Podlaskie
Poland 10 Wojskowy Szpital Kliniczny z Poliklinika - Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Bydgoszczy Bydgoszcz
Poland Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Kujawsko-Pomorskie
Poland Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman Gdynia
Poland Szpitale Pomorskie Sp. z o.o. Gdynia
Poland Szpitale Pomorskie Sp. z o.o. Gdynia Pomorskie
Poland Pratia S.A. Jelenia Góra Dolnoslaskie
Poland Cardiomedicum Sp. z o.o. Kraków Malopolskie
Poland Uniwersytecki Szpital Kliniczny Im Wojskowej Akademii Medycznej Centralny Szpital Weteranow Lodz Lodzkie
Poland Formed 2 Sp. z o.o. Oswiecim Malopolskie
Poland Uniwersytecki Szpital Kliniczny W Poznaniu Poznan
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach Pulawy Lubelskie
Poland Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji Warszawa
Portugal CHTâmega e Sousa - Hospital Padre Américo Guilhufe - Penafiel
Portugal Centro Hospitalar Lisboa Norte Lisboa
Portugal Hospital da Luz Lisboa
Portugal CHLO, EPE - Hospital São Francisco Xavier Lisbon
Portugal Centro Hospitalar de Setubal Setubal
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Universitario de Salamanca Salamanca Castilla Y León
Spain Hospital Virgen del Camino - Sanlúcar de Barrameda Sanlúcar de Barrameda
Spain Complejo Hospitalario Universitario de Santiago Santiago de Compostela
Spain Clínica Nuevas Tecnologías en Diabetes y Endocrinología Sevilla
Spain Hospital Nisa Sevilla Aljarafe Sevilla
Spain Fundación para la Investigación del Hospital Clínico de Valencia (INCLIVA) Valencia
Turkey T.C. Saglik Bakanligi Adana Sehir Egitim ve Arastirma Hastan Adana
Turkey Afyonkarahisar Health Sciences University Afyon
Turkey Ankara Sehir Hastanesi Cardiology Ankara
Turkey Bursa Sehir Hastanesi Cardiology Bursa
Turkey Trakya University Edirne
Turkey Basaksehir Cam ve Sakura Sehir Hastanesi Istanbul
Turkey Erciyes University Cardiology Kayseri
Turkey Kocaeli Universitesi Tip Fakultesi Hastanesi Kocaeli
United Kingdom Ninewells Hospital Dundee
United Kingdom Raigmore Hospital Inverness Highland
United Kingdom Peterborough City Hospital Peterborough
United Kingdom St. Richards Hospital West Sussex
United States Advanced Cariodvascular LLC Alexander City Alabama
United States PharmaTex Research Amarillo Texas
United States Maryland Cardiovascular Specialists - Baltimore Baltimore Maryland
United States Cardio and Vascular Assoc-CAVA Bloomfield Hills Michigan
United States University Of North Carolina At Chapel Hill Chapel Hill North Carolina
United States University of Texas Southwestern Medical Center Dallas Texas
United States David Turbay, MD, PLLC El Paso Texas
United States Eastern Shore Rsrch Inst, LLC Fairhope Alabama
United States Chicago Medical Research LLC Hazel Crest Illinois
United States AMS Cardiology Horsham Pennsylvania
United States Kansas City VA Medical Center Kansas City Missouri
United States Private Practice Leadership LLC. Katy Texas
United States Long Island Cardiovascular Consultants PC Lake Success New York
United States Clearwater Cardiovascular Consultants Largo Florida
United States Cardiology & Medicine Clinic Little Rock Arkansas
United States UofL Health Care Outpatient Louisville Kentucky
United States GA Arrhythmia Cons & Rsch Inst Macon Georgia
United States Mount Sinai Hosp at NYC New York New York
United States Sentara Clinical Research Norfolk Virginia
United States Valley Clinical Trials, Inc. Northridge California
United States UCI Health Orange California
United States Ormond Beach Clinical Research Ormond Beach Florida
United States MD Medical Research Oxon Hill Maryland
United States South California Heart Spc Pasadena California
United States University of Pennsylvania Hospital Philadelphia Pennsylvania
United States Renown Children's Hospital Reno Nevada
United States Virginia Commonwealth University Richmond Virginia
United States Northwell Health Phys Cardio Riverhead New York
United States St Johns Ctr Clin Rsch-St. Aug Saint Augustine Florida
United States Washington University Saint Louis Missouri
United States Clinical Advancement Ctr, PLLC San Antonio Texas
United States Clinical Advancement Ctr, PLLC San Antonio Texas
United States Velocity Clin Rsrch - Savannah Savannah Georgia
United States Sherman Clinical Research Sherman Texas
United States Northwest Heart Center Tomball Texas

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Greece,  India,  Malaysia,  Poland,  Portugal,  Spain,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score (KCCQ-CSS) Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Participant achieving threshold for clinically meaningful within-participant change in KCCQ CSS (yes/no) Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Participant achieving threshold for clinically meaningful within-participant change in 6-minute walk distance (6MWD) (yes/no) Measured as count of participants. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Participants improving 5 points or more in KCCQ-CSS (yes/no) Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Participants improving 10 points or more in KCCQ-CSS (yes/no) Measured as count of participants. The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Change in subscales of KCCQ (total symptom score, physical limitations score, social limitations score, and health-related quality of life) Measured as score (score on scale; range 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Change in six-minute walk distance (6MWD) Measured in meters. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Change in high-sensitivity C-reactive protein (hs-CRP) Measured as ratio to baseline. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Participants experiencing improvement in New York heart association (NYHA) Class (yes/no) Measured as count of participants. The New York Heart Association (NYHA) classification provides a simple way of classifying the extent of heart failure (HF). It classifies patients in one of four categories based on their limitations during physical activity - Class I: Participant with cardiac disease but without resulting limitations of physical activity, Class II: Participants with cardiac disease resulting in slight limitation of physical activity, Class III: Participants with cardiac disease resulting in marked limitation of physical activity, Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Change in N-terminal-pro-brain natriuretic peptide (NT-proBNP) Measured as ratio to baseline. From randomisation (month 0) to end-of-treatment (month 12)
Secondary Change in eGFR (CKD-EPI) eGFR (CKD-EPI) is estimated glomerular filtration rate chronic kidney disease - epidemiology collaboration. Measured in milliliter per minute per 1.73 square meter (ml/min/1.73^2). From randomisation (month 0) to end-of-treatment (month 12)
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Active, not recruiting NCT05896904 - Clinical Comparison of Patients With Transthyretin Cardiac Amyloidosis and Patients With Heart Failure With Reduced Ejection Fraction N/A
Completed NCT05077293 - Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Recruiting NCT05631275 - The Role of Bioimpedance Analysis in Patients With Chronic Heart Failure and Systolic Ventricular Dysfunction
Enrolling by invitation NCT05564572 - Randomized Implementation of Routine Patient-Reported Health Status Assessment Among Heart Failure Patients in Stanford Cardiology N/A
Enrolling by invitation NCT05009706 - Self-care in Older Frail Persons With Heart Failure Intervention N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Recruiting NCT06340048 - Epicardial Injection of hiPSC-CMs to Treat Severe Chronic Ischemic Heart Failure Phase 1/Phase 2
Recruiting NCT05679713 - Next-generation, Integrative, and Personalized Risk Assessment to Prevent Recurrent Heart Failure Events: the ORACLE Study
Completed NCT04254328 - The Effectiveness of Nintendo Wii Fit and Inspiratory Muscle Training in Older Patients With Heart Failure N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05538611 - Effect Evaluation of Chain Quality Control Management on Patients With Heart Failure
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Completed NCT06026683 - Conduction System Stimulation to Avoid Left Ventricle Dysfunction N/A
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT05564689 - Absolute Coronary Flow in Patients With Heart Failure With Reduced Ejection Fraction and Left Bundle Branch Block With Cardiac Resynchronization Therapy