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Can a heart drug mend damage from breast cancer therapy?

NCT ID NCT05806138

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study tests whether adding vericiguat to standard heart failure care can improve heart function in people with breast cancer who developed heart problems after cancer treatment. Participants will be randomly assigned to receive either vericiguat plus usual care or usual care alone. The main goal is to see if vericiguat improves exercise capacity, measured by a cardiopulmonary exercise test, after six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vericiguat
What this could lead to
If effective, vericiguat could become a new treatment to help breast cancer survivors recover heart function weakened by cancer therapy.
What could go wrong
This is a small, early-stage trial, so results may not apply broadly. Vericiguat may cause side effects or may not improve heart function more than standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

21 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 of the following criteria at screening: * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments * 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 * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy, but not tubal ligation. * Male subjects should be willing to use barrier contraception °Willing and able to comply with the requirements of the protocol. Exclusion Criteria: * Systolic blood pressure \< 90 mmHg * 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). * Concurrent or anticipated use of a phosphodiesterase inhibitor (e.g., vardenafil, tadalafil, or sildenafil). * Cardiac comorbidity, including any of the following: * Hypertrophic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac sarcoidosis, or amyloid cardiomyopathy * Uncontrolled arrhythmia * Uncorrected congenital cardiac disease * Acute coronary syndrome, percutaneous coronary intervention, or coronary artery bypass graft surgery within 3 months prior to randomization. * Symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke within 3 months prior to randomization. * Cardiac transplantation * Valvular heart disease requiring surgery or intervention * Non-cardiac comorbidity, including any of the following: * eGFR \< 15ml/min/1.73m\^2 (based upon CKD-EPI, Cockroft-Gault, etc.) * Severe hepatic insufficiency (e.g., Child-Pugh C) * Severe pulmonary disease, such as requiring continuous home oxygen or interstitial lung disease * Other medical disorder or condition that in the opinion of the investigator would impair the subject's ability to participate or complete the study * Subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction (within 30 days of any planned study procedures) * Unstable angina * Uncontrolled arrhythmias causing symptoms or hemodynamic compromise, * Symptomatic severe aortic stenosis * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures) * Thrombosis of lower extremities (within 3 months of any planned study procedures) * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Room air desaturation at rest ≤85% * Respiratory failure * Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) * Mental impairment leading to inability to cooperate. * Current alcohol and/or drug abuse * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.