RECRUITING

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation

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

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.

Official Title

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

Quick Facts

Study Start:2024-04-01
Study Completion:2026-09-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06200207

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 or equal to 2 milligrams per liter (mg/L) at screening (visit 1)
  2. * Disease specific - cardiovascular:
  3. * 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
  4. * Diagnosis of heart failure (New York heart association (NYHA) Class II-III)
  5. * 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)
  6. * 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:
  7. 1. Left atrial (LA) volume index greater than 34 milliliter per square meter (mL/m\^2)
  8. 2. LA diameter greater than or equal to 3.8 centimeter (cm)
  9. 3. LA length greater than or equal to 5.0 cm
  10. 4. LA area greater than or equal to 20 square centimeter (cm\^2)
  11. 5. LA volume greater than or equal to 55 milliliter (mL)
  12. 6. Intraventricular septal thickness greater than or equal to 1.1 cm
  13. 7. Posterior wall thickness greater than or equal to 1.1 cm
  14. 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
  15. * No heart failure hospitalisations or urgent heart failure visits between screening and randomisation
  16. * Able to perform the 6-minute walk test (6MWT) at screening with a minimum distance of 100 metres
  17. * Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score lesser than 80 at screening
  1. * Medical conditions - cardiovascular:
  2. * Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart failure hospitalisation within 30 days prior to screening (visit 1)
  3. * 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
  4. * Heart rate above 110 or below 40 beats per minute as evaluated on the Electrocardiogram (ECG) performed at screening (visit 1)
  5. * Planned coronary, carotid or peripheral artery revascularisation known during the screening period (visit 1)
  6. * Planned cardiac device or atrial flutter/atrial fibrillation ablation procedure known during the screening period (visit 1)
  7. * 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)
  8. * 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
  9. * Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including chronic obstructive pulmonary disease (COPD)
  10. * Any other condition judged by the investigator that could account for heart failure symptoms and signs (e.g., anaemia, hypothyroidism)
  11. * Medical conditions - infections/immunosuppression:
  12. * Clinical evidence of, or suspicion of, active infection at the discretion of the investigator

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
Cardiology & Medicine Clinic
Little Rock, Arkansas, 72204
United States
Valley Clinical Trials, Inc.
Northridge, California, 91325
United States
UCI Health
Orange, California, 92868
United States
South California Heart Spc
Pasadena, California, 91105
United States
Clearwater Cardiovascular Consultants
Largo, Florida, 33777
United States
Ocala Cardiovascular Research
Ocala, Florida, 34471
United States
Ormond Beach Clinical Research
Ormond Beach, Florida, 32174
United States
St Johns Ctr Clin Rsch-St. Aug
Saint Augustine, Florida, 32086
United States
GA Arrhythmia Cons & Rsch Inst
Macon, Georgia, 31201
United States
Velocity Clin Rsrch - Savannah
Savannah, Georgia, 31406
United States
Chicago Medical Research LLC
Hazel Crest, Illinois, 60429
United States
UofL Health Care Outpatient
Louisville, Kentucky, 40202
United States
Maryland Cardiovascular Specialists - Baltimore
Baltimore, Maryland, 21229
United States
MD Medical Research
Oxon Hill, Maryland, 20745
United States
Cardio and Vascular Assoc-CAVA
Bloomfield Hills, Michigan, 48304
United States
Pulse Cardiology
Farmington Hills, Michigan, 48334
United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128
United States
Washington University
Saint Louis, Missouri, 63110
United States
Renown Children's Hospital
Reno, Nevada, 89502
United States
Long Island Cardiovascular Consultants PC
Lake Success, New York, 11042
United States
Mount Sinai Hosp at NYC
New York, New York, 10019
United States
Northwell Health Phys Cardio
Riverhead, New York, 11901
United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599-7046
United States
AMS Cardiology
Horsham, Pennsylvania, 19044
United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104
United States
PharmaTex Research
Amarillo, Texas, 79106
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9302
United States
David Turbay, MD, PLLC
El Paso, Texas, 79905
United States
Private Practice Leadership LLC.
Katy, Texas, 77493
United States
Clinical Advancement Ctr, PLLC
San Antonio, Texas, 78212
United States
Clinical Advancement Ctr, PLLC
San Antonio, Texas, 78212
United States
Sherman Clinical Research
Sherman, Texas, 75092
United States
Northwest Heart Center
Tomball, Texas, 77375
United States
Sentara Clinical Research
Norfolk, Virginia, 23507
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
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 Date2024-04-01
Study Completion Date2026-09-10

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2026-09-10

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure
  • Systemic Inflammation