A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction (NCT05806138) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Vericiguat in People With Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction
United States21 participantsStarted 2023-07-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Age ≥ 18 years
* Biopsy proven breast cancer (stage I-IV)
* 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.
* 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:
* Achieving a plateau oxygen consumption, concurrent with an increase in power output;
* A respiratory exchange ratio ≥ 1.00;
* 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)
* Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
* 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:
* 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 o…