Could heart failure patients skip some drugs after surgery? new trial investigates
NCT ID NCT07572032
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study looks at whether people with heart failure caused by a treatable problem, like a blocked artery or a faulty heart valve, can safely wait to start certain heart failure medications after the problem is fixed. About 80 adults whose heart function improved after surgery or a procedure will be randomly assigned to either start the drugs right away or wait 6 months. The goal is to see if waiting is just as good for heart function and overall health, which could help avoid unnecessary medications.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. * Preoperative left ventricular ejection fraction (LVEF) ≤ 40% on echocardiography. * Successful surgical or procedural correction of a correctable underlying cause of heart failure: Valvular heart disease: mitral valve surgery, aortic valve surgery, transcatheter aortic valve implantation (TAVI), or tricuspid valve surgery, OR Ischemic cardiomyopathy: complete revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). * Enrollment between 3 months before and 10 days after the corrective procedure. * Hemodynamically stable post-operative state with NYHA class I, defined at the time of randomization as: Systolic blood pressure ≥ 90 mmHg sustained for at least 6 hours; No up-titration of intravenous diuretics within the preceding 6 hours; No use of intravenous vasodilators within the preceding 6 hours; No use of intravenous inotropes within the preceding 24 hours; Heart rate 50-110 bpm and no clinical signs of volume overload. * Patients receiving ARNI or SGLT2 inhibitors prior to enrollment must complete a 1-week washout period before randomization. Provision of written informed consent. Exclusion Criteria: * Prior history of sustained ventricular tachycardia or ventricular fibrillation. * Greater-than-moderate paravalvular leak or residual mitral regurgitation after aortic or mitral valve surgery. * Incomplete revascularization in patients with coronary artery disease (residual significant disease in any major coronary territory: LAD, LCX, or RCA). * Graft occlusion documented on coronary CT angiography after CABG. Planned pregnancy during the study period. * Uncontrolled hypertension on medical therapy (systolic blood pressure \> 160 mmHg). * Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m². * Inability to tolerate ARNI, defined as inability to take sacubitril/valsartan 25 mg twice daily (e.g., due to symptomatic hypotension, history of angioedema, or bilateral renal artery stenosis). * Inability to tolerate SGLT2 inhibitors (e.g., type 1 diabetes mellitus or history of recurrent diabetic ketoacidosis). * Any other condition that, in the opinion of the investigator, would interfere with study participation or follow-up.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ajou University Hospital
NOT_YET_RECRUITINGSuwon, Gyeonggi-do, 16499, South Korea
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Keimyung University Dongsan Hospital
RECRUITINGDaegu, Daegu, 42601, South Korea
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Korea University Anam Hospital
NOT_YET_RECRUITINGSeoul, Seoul, 02841, South Korea
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Seoul National University Bundang Hospital
NOT_YET_RECRUITINGSeongnam-si, Gyeonggi-do, 13620, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can daily mindful breathing ease heart failure symptoms?
- Can a smartphone app keep heart failure patients out of the hospital?
- Can better training get doctors to talk about what matters most to dying veterans?
- Can AI read heart ultrasounds as well as trained sonographers?
- Can modern heart failure drugs reverse damage in three months?