RECRUITING

A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Heart Failure and Inflammation

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Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will be done to see if ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get ziltivekimab or placebo. Participants will get study medicine for once-monthly injections either in a pre-filled syringe to inject the study medicine into a skinfold or a pen-injector to inject the study medicine into flat skin. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires.

Official Title

Effects of Ziltivekimab Versus Placebo on Morbidity and Mortality in Patients With Heart Failure With Mildly Reduced or Preserved Ejection Fraction and Systemic Inflammation

Quick Facts

Study Start:2023-05-08
Study Completion:2027-07-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05636176

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Serum high-sensitivity C-reactive protein (hs-CRP) greater than equal to 2 milligrams per liter (mg/L) at screening (visit 1) Disease specific - cardiovascular
  2. * At least one of the following:
  3. 1. N-terminal-pro-brain natriuretic peptide (NT-proBNP) greater than equal to 300 picograms per milliliter (pg/mL) at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NTproBNP must be greater than equal to 600 pg/mL. Note that the screening electrocardiogram (ECG) must be obtained the same day as sampling for NT-proBNP.
  4. 2. Hospitalisation or urgent/unplanned visit with a primary diagnosis of decompensated heart failure which required intravenous loop diuretic treatment, within the last 9 months prior to screening (visit 1) in combination with NT-proBNP greater than equal to 200 pg/mL at screening (Visit 1) for patients without ongoing atrial fibrillation/flutter. If ongoing atrial fibrillation/flutter at screening (visit 1), NT-proBNP must be greater than equal to 600 pg/mL.
  5. * Diagnosis of heart failure (New York Heart Association \[classification\] \[NYHA\] Class II-IV).
  6. * Left ventricular ejection fraction (LVEF) greater than 40 percentage (%) 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 (e.g., myocardial infarction \[MI\] or heart failure \[HF\] hospitalisation).
  7. * 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:
  8. * Left atrial (LA) volume index greater than 34 milliliter per meter square (mL/m\^2).
  9. * LA diameter greater than equal to 3.8 centimeter (cm).
  10. * LA length greater than equal to 5.0 cm.
  11. * LA area greater than equal to 20 cm square.
  12. * LA volume greater than equal to 55 milliters (mL).
  13. * Intraventricular septal thickness greater than equal to 1.1 cm.
  14. * Posterior wall thickness greater than equal to 1.1 cm.
  15. * Left ventricular (LV) mass index greater than equal to 115 grams per meter square (g⁄m\^2 ) in men or greater than equal to 95 g⁄m\^2 in women.
  16. * E/e' (mean septal and lateral) greater than equal to 10.
  17. * e' (mean septal and lateral) less than 9 centimeter per second (cm/s).
  18. * No heart failure hospitalisations or urgent heart failure visits between screening (visit 1) and randomisation (visit 2).
  1. * Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation, within 30 days prior to screening (visit 1).
  2. * Systolic blood pressure greater than 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 equal to 3 antihypertensive drugs. (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
  3. * Heart rate above 110 or below 40 beats per minute as evaluated on the electrocardiogram (ECG) performed at screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit window and without rescreening, at the discretion of the investigator).
  4. * Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1). (Note: Planned coronary angiogram is not exclusionary).
  5. * Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1).
  6. * 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).
  7. * 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.
  8. * Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD.
  9. * Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism).

Contacts and Locations

Study Contact

Novo Nordisk
CONTACT
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Principal Investigator

Clinical Transparency (dept. 2834)
STUDY_DIRECTOR
Novo Nordisk A/S

Study Locations (Sites)

Advanced Cardiovascular, LLC
Alexander City, Alabama, 35010
United States
Eastern Shore Rsrch Inst, LLC
Fairhope, Alabama, 36532
United States
Heart Center Rsrch_Hunstville
Huntsville, Alabama, 35801
United States
Banner University Medical Ctr
Phoenix, Arizona, 85006
United States
Banner University Medical Ctr
Phoenix, Arizona, 85006
United States
Cardiology & Medicine Clinic
Little Rock, Arkansas, 72204
United States
National Heart Institute Cal
Beverly Hills, California, 90211
United States
Valley Clinical Trials
Covina, California, 91723
United States
Scripps Memorial Hospital La Jolla
La Jolla, California, 90237
United States
Purushotham & Akther Kotha MD, inc.
La Mesa, California, 91942
United States
VA Loma Linda Hlthcr Sys
Loma Linda, California, 92357
United States
VA Greater Los Angeles Hlthcare System
Los Angeles, California, 90073
United States
Valley Clinical Trials, Inc.
Northridge, California, 91325
United States
UCI Health
Orange, California, 92868
United States
Stanford Univ School of Med
Palo Alto, California, 94304
United States
San Diego Cardiac Center
San Diego, California, 92123
United States
North America Research Institute
San Dimas, California, 91773
United States
Manshadi Heart Institute
Stockton, California, 95204
United States
Lundquist Inst-Biomed Innovtn
Torrance, California, 90502
United States
InvivoCure
Van Nuys, California, 91405
United States
Rocky Mountain Regional VAMC
Aurora, Colorado, 80045
United States
S Denver Cardiology Associates
Littleton, Colorado, 80120
United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610
United States
Cardiology Associates of Fairfield County
Stamford, Connecticut, 06905
United States
Pioneer Clinical Studies-Coral Gables
Coral Gables, Florida, 33134
United States
Nature Coast Clin Rsrch_Crystal River
Crystal River, Florida, 34429
United States
Integrative Research Assoc Inc
Fort Lauderdale, Florida, 33312
United States
Memorial Region Hosp_Hollywood
Hollywood, Florida, 33021
United States
E Coast Inst for Rsrch LLC_Jacksonville
Jacksonville, Florida, 32204
United States
Jacksonville Ctr for Clin Res
Jacksonville, Florida, 32216
United States
Baptist Health Research Institute
Jacksonville, Florida, 32258
United States
Amavita Research Services, LLC
Miami, Florida, 33137
United States
Baptist Health South Florida
Miami, Florida, 33173
United States
NCH Research Institute
Naples, Florida, 34102
United States
Ocala Cardiovascular Research
Ocala, Florida, 34471
United States
St Johns Ctr Clin Rsch-St. Aug
Saint Augustine, Florida, 32086
United States
Cardio Partners Clin Res Inst
Wellington, Florida, 33449
United States
Winter Haven Hospital
Winter Haven, Florida, 33881
United States
Morehouse School of Medicine
Atlanta, Georgia, 30310
United States
Emory University School of Medicine_Atlanta
Atlanta, Georgia, 30322
United States
NSC Research, Inc
Johns Creek, Georgia, 30024
United States
GA Arrhythmia Cons & Rsch Inst
Macon, Georgia, 31201
United States
The Queen's Medical Center
Honolulu, Hawaii, 96817
United States
St. Luke's Idaho Cardiology Associates
Meridian, Idaho, 83642
United States
Northwest Heart Clin. Res.
Arlington Heights, Illinois, 60005
United States
Advocate Good Samaritan
Downers Grove, Illinois, 60515
United States
Chicago Medical Research LLC
Hazel Crest, Illinois, 60429
United States
CIS Research _Naperville
Naperville, Illinois, 60540
United States
OSF HealthCare_Cardiovasc Inst
Peoria, Illinois, 61614
United States
Methodist Medical_Center of Illinois
Peoria, Illinois, 61636
United States
Midwest Cardiovascu Rsrch Foundation
Elkhart, Indiana, 46514
United States
Asha Clinical Rsch-Munster, LLC
Hammond, Indiana, 46324
United States
Franciscan Network-IN Heart PHY
Indianapolis, Indiana, 46237
United States
Witham Health Services
Lebanon, Indiana, 46052
United States
Cardiovascular Rsrch of NW_IN
Munster, Indiana, 46321
United States
Reid Physician Associates
Richmond, Indiana, 47374
United States
University Of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Midwest Heart & Vasc Spec
Overland Park, Kansas, 66211
United States
Midwest Heart & Vasc Spec
Overland Park, Kansas, 66211
United States
Baptist Health Hardin
Elizabethtown, Kentucky, 42701
United States
The Research Group of Lexington LLC
Lexington, Kentucky, 40503
United States
University Of Louisville
Louisville, Kentucky, 40202
United States
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
United States
Baptist Health Louisville
Louisville, Kentucky, 40207
United States
Cambridge Medical Trials
Alexandria, Louisiana, 71301
United States
LOUISIANA HEART Center
Bogalusa, Louisiana, 70427
United States
Heart Clinic of Hammond
Hammond, Louisiana, 70403
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Ascension Saint Agnes Heart Ca
Baltimore, Maryland, 21229
United States
Johns Hopkins University_Baltimore
Baltimore, Maryland, 21287
United States
Capitol Cardiology Assoc_Lanham
Lanham, Maryland, 20706
United States
MD Medical Research
Oxon Hill, Maryland, 20745
United States
Pentucket Medical Associates
Haverhill, Massachusetts, 01830
United States
University of Michigan Medicine
Ann Arbor, Michigan, 48109
United States
Detroit Med Center-Wayne State
Detroit, Michigan, 48201
United States
Henry Ford Hlth System_Detroit
Detroit, Michigan, 48202
United States
Elite Research Center
Flint, Michigan, 48532
United States
Healthy Heart Cardiology
Grand Rapids, Michigan, 49546
United States
Trinity Health Michigan Heart
Ypsilanti, Michigan, 48197
United States
Fairview Health Services
Maplewood, Minnesota, 55109
United States
Fairview Health Services
Maplewood, Minnesota, 55109
United States
Minneapolis VA Health Care Sys
Minneapolis, Minnesota, 55417
United States
Cardiolg Assoc Rsch LLC_Tupelo
Tupelo, Mississippi, 38801
United States
St Louis Heart & Vascular, P.C.
Saint Louis, Missouri, 63136
United States
Logan Health Research
Kalispell, Montana, 59901
United States
Univ. of Nebraska Medical Center_Omaha
Omaha, Nebraska, 68198
United States
Advanced Heart Care LLC
Bridgewater, New Jersey, 08807-3064
United States
Heart House_Elmer
Elmer, New Jersey, 08318
United States
NJ Heart
Linden, New Jersey, 07036
United States
NJ Heart
Linden, New Jersey, 07036
United States
Barnabas Health
Livingston, New Jersey, 07039
United States
Inspira Health
Mullica Hill, New Jersey, 08062
United States
Saint Michael's Med Ctr NJ
Newark, New Jersey, 07102
United States
Saint Michael's Med Ctr NJ
Newark, New Jersey, 07102
United States
The Valley Hosptial
Ridgewood, New Jersey, 07450
United States
The Valley Hosptial
Ridgewood, New Jersey, 07450
United States
Capital Cardiology Associates_Albany
Albany, New York, 12211
United States
Chear Center LLC
Bronx, New York, 10455
United States
University at Buffalo_Erie County Med Ctr
Buffalo, New York, 14215
United States
Marian David, MD, PC
Kew Gardens, New York, 11415
United States
Mount Sinai Hosp at NYC
New York, New York, 10019
United States
NY Presbyt Hosp-W Cornell Med
New York, New York, 10021
United States
Mount Sinai Hosp at NYC
New York, New York, 10029
United States
Harlem Cardiology_Madison ave
New York, New York, 10035
United States
Laurelton Heart Specialist PC
Rosedale, New York, 11422
United States
Laurelton Heart Specialist PC
Rosedale, New York, 11422
United States
Saratoga Clinical Research
Saratoga Springs, New York, 12866
United States
Stony Brook University Hospital
Stony Brook, New York, 11794
United States
UNC Cardiology Outpatient Ctr
Chapel Hill, North Carolina, 27599
United States
Duke University
Durham, North Carolina, 27710
United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27405
United States
Duke University/Southeastern
Lumberton, North Carolina, 28358
United States
Duke University/Southeastern
Lumberton, North Carolina, 28358
United States
Carteret Medical Group
Morehead City, North Carolina, 28557
United States
UNC Rex Healthcare
Raleigh, North Carolina, 27607
United States
Aultman Hospital
Canton, Ohio, 44710
United States
Rama Research LLC
Marion, Ohio, 43302
United States
South Oklahoma Heart Research, LLC
Oklahoma City, Oklahoma, 73135
United States
Capital Area Research LLC
Camp Hill, Pennsylvania, 17011
United States
Penn State Hlth Holy Spirit Med Ctr
Camp Hill, Pennsylvania, 17011
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Heart Grp_ Lancaster Gen Hlth
Lancaster, Pennsylvania, 17603
United States
Thomas Jefferson University_Philadelphia
Philadelphia, Pennsylvania, 19114
United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
United States
Penn State Health-Berks Cardiology
Wyomissing, Pennsylvania, 19610
United States
Prisma Health-Midlands
Columbia, South Carolina, 29203
United States
Monument Health Clinical Rsrch
Rapid City, South Dakota, 57701
United States
Sanford Health_Sioux Falls
Sioux Falls, South Dakota, 57117
United States
Apex Research Foundation, LLC
Jackson, Tennessee, 38301
United States
The Jackson Clinic, PA
Jackson, Tennessee, 38305
United States
Tennova HC Turkey Creek MC
Knoxville, Tennessee, 37934
United States
Heart MD_Allen TX
Allen, Texas, 75013
United States
PharmaTex Research, LLC
Amarillo, Texas, 79106
United States
Austin Heart
Austin, Texas, 78756
United States
UTD SW Medical Center-Dallas
Dallas, Texas, 75390
United States
Dallas Heart and Vascular
Duncanville, Texas, 75137
United States
David Turbay, MD, PLLC
El Paso, Texas, 79905
United States
Biopharma Informatic_Houston
Houston, Texas, 77025
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Texas Heart Inst Medical Ctr
Houston, Texas, 77030
United States
UT Physicians - Houston Medical Center
Houston, Texas, 77030
United States
Cardiovasc Spec of Willowbrook
Houston, Texas, 77070
United States
Texas Institute of Cardiology PA
McKinney, Texas, 75071
United States
Clinical Advancement Ctr, PLLC
San Antonio, Texas, 78212
United States
Audie L. Murphy VA Hospital
San Antonio, Texas, 78229
United States
Sherman Clinical Research
Sherman, Texas, 75092
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States
University of Virginia
Charlottesville, Virginia, 22908
United States
James River Cardiology
Chesterfield, Virginia, 23832
United States
Virginia Heart
Falls Church, Virginia, 22042
United States
Carient Heart and Vascular
Manassas, Virginia, 20109
United States
York Clinical Research LLC
Norfolk, Virginia, 23504
United States
Sentara Clinical Research
Norfolk, Virginia, 23507
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
Roanoke Heart Institute
Roanoke, Virginia, 24014
United States
VA Medical Center_Salem
Salem, Virginia, 24153-6404
United States
Selma Medical Associates
Winchester, Virginia, 22601-3834
United States
Selma Medical Associates
Winchester, Virginia, 22601-3834
United States
Valley Health Link
Winchester, Virginia, 22601
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Swedish Medical Center_Seattle
Seattle, Washington, 98122-5789
United States
Swedish Medical Center_Seattle
Seattle, Washington, 98122-5789
United States
Providence Med Research Ctr
Spokane, Washington, 99204
United States
WVU Heart & Vascular Institute
Morgantown, West Virginia, 26506
United States
William S Middleton Mem VA Hosp
Madison, Wisconsin, 53705
United States
Aurora St. Luke's Medical Centr
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

  • Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-08
Study Completion Date2027-07-02

Study Record Updates

Study Start Date2023-05-08
Study Completion Date2027-07-02

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure