ACTIVE_NOT_RECRUITING

A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction

Talk to us

Conditions

Breast CancerCardiac DysfunctionVericiguatCancer Therapy-Related Cardiac Dysfunction (CTRCD)23-050

Quick Navigation

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 purpose of this study is to find out if adding vericiguat to standard treatment for cancer therapy related cardiac dysfunction (CTRCD) is more effective than standard treatment alone. The addition of vericiguat to the usual treatment could help improve cardiac function, but it could also cause side effects. This study will help researchers find out whether this different treatment is better, the same as, or worse than the usual approach.

Official Title

A Randomized Controlled Trial of the Soluble Guanylate Cyclase Stimulator Vericiguat in Patients With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction (ELEVATE)

Quick Facts

Study Start:2023-07-17
Study Completion:2028-07-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05806138

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:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Biopsy proven breast cancer (stage I-IV)
  3. * Cancer treatment related cardiac dysfunction (CTRCD), established by an absolute decrease in LVEF ≥ 10% from baseline/pre-treatment to \< 53% and attributable to prior cardiotoxic cancer treatment, per the clinical investigator.
  4. * Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria:
  5. * Achieving a plateau oxygen consumption, concurrent with an increase in power output;
  6. * A respiratory exchange ratio ≥ 1.00;
  7. * Attainment of maximal predicted heart rate, as defined by a peak heart rate within 10bpm of the age predicted maximal heart rate (220 - Age\[years\]); or if on a beta-blocker, 164 - (age \* 0.7)
  8. * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
  9. * Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-earing potential while receiving study drug and for 30 days after the last dose of study drug:
  10. * Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test (within 6 months prior to study enrollment) and not be breast-feeding prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
  11. * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
  12. * Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the postmenopausal range for the institution
  13. * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation.
  14. * Male subjects should be willing to use barrier contraception °Willing and able to comply with the requirements of the protocol.
  1. * Systolic blood pressure \< 90 mmHg
  2. * Concurrent or anticipated use of a long-acting nitrate or NO donor (e.g., nitroglycerin, isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal NTG patch, or molsidomine).
  3. * Concurrent or anticipated use of a phosphodiesterase inhibitor (e.g., vardenafil, tadalafil, or sildenafil).
  4. * Cardiac comorbidity, including any of the following:
  5. * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, or amyloid cardiomyopathy
  6. * Uncontrolled arrhythmia
  7. * Uncorrected congenital cardiac disease
  8. * Acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft surgery within 3 months prior to randomization.
  9. * Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 3 months prior to randomization.
  10. * Cardiac transplantation
  11. * Valvular heart disease requiring surgery or intervention
  12. * Non-cardiac comorbidity, including any of the following:
  13. * eGFR \< 15ml/min/1.73m\^2 (based upon CKD-EPI, Cockroft-Gault, etc.)
  14. * Severe hepatic insufficiency (e.g., Child-Pugh C)
  15. * Severe pulmonary disease, such as requiring continuous home oxygen or interstitial lung disease
  16. * Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or complete the study
  17. * Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing:
  18. * Acute myocardial infarction (within 30 days of any planned study procedures)
  19. * Unstable angina
  20. * Uncontrolled arrhythmias causing symptoms or hemodynamic compromise,
  21. * Symptomatic severe aortic stenosis
  22. * Recurrent syncope
  23. * Active endocarditis
  24. * Acute myocarditis or pericarditis
  25. * Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures)
  26. * Thrombosis of lower extremities (within 3 months of any planned study procedures)
  27. * Suspected dissecting aneurysm
  28. * Uncontrolled asthma
  29. * Pulmonary edema
  30. * Room air desaturation at rest ≤85%
  31. * Respiratory failure
  32. * Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis)
  33. * Mental impairment leading to inability to cooperate.
  34. * Current alcohol and/or drug abuse
  35. * Any other condition or intercurrent illness (e.g., symptomatic weight-bearing bone metastases or limited life expectancy \< 6-9 months) that, in the opinion of the investigator, makes the participant a poor candidate for the trial

Contacts and Locations

Principal Investigator

Anthony Yu, MD, MS
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Anthony Yu, MD, MS, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Date2023-07-17
Study Completion Date2028-07-17

Study Record Updates

Study Start Date2023-07-17
Study Completion Date2028-07-17

Terms related to this study

Keywords Provided by Researchers

  • Vericiguat
  • Cancer Therapy-Related Cardiac Dysfunction (CTRCD)
  • 23-050

Additional Relevant MeSH Terms

  • Breast Cancer
  • Cardiac Dysfunction