[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651217":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":46,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":26},{"fullName":5,"class":6},"University Medical Center Mainz","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL","Subjects randomized to this arm undergo transcatheter edge-to-edge repair (M-TEER) of the mitral valve within 7 days of randomization, in addition to a standardized, protocol-driven guideline-directed medical therapy (GDMT) up-titration regimen. Starting on the first post-procedural day, subjects are up-titrated toward optimal target doses of a beta-blocker, ACE inhibitor\u002FARB\u002FARNI, a mineralocorticoid receptor antagonist, and an SGLT2 inhibitor, guided by protocol-defined thresholds for blood pressure, heart rate, potassium, and renal function, with formal safety\u002Ftolerability reassessment at 2, 4, 6, 8, 10, and 12 weeks.",[13,14],"Device: M-TEER","Other: Standardized GDMT Up-Titration",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","Subjects randomized to this arm receive the identical standardized, protocol-driven GDMT up-titration regimen as the Intervention group, without early M-TEER. Up-titration toward optimal target doses of a beta-blocker, ACE inhibitor\u002FARB\u002FARNI, a mineralocorticoid receptor antagonist, and an SGLT2 inhibitor begins at randomization and follows the same protocol-defined safety thresholds and visit schedule (2, 4, 6, 8, 10, and 12 weeks) as the Intervention group. Subjects may cross over to M-TEER or mitral valve surgery after completion of the 12-week follow-up visit, or earlier in the case of an intervening heart failure hospitalization.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","M-TEER","Transcatheter edge-to-edge repair (M-TEER) of the mitral valve, performed once, within 7 days of randomization, in subjects randomized to the Intervention arm.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standardized GDMT Up-Titration","A protocol-driven regimen applied to all randomized subjects, beginning at randomization (Control arm) or on the first post-procedural day (Intervention arm). Subjects are started on a beta-blocker, ACE inhibitor\u002FARB\u002FARNI, a mineralocorticoid receptor antagonist, and an SGLT2 inhibitor, targeting at least half of each drug's optimal dose immediately (full dose for the SGLT2 inhibitor), with same-day achievement recommended if hemodynamically stable. Formal reassessment occurs at 2, 4, 6, 8, 10, and 12 weeks, with up-titration to full optimal doses of beta-blocker, ACEi\u002FARB\u002FARNI, and MRA targeted by week 6, contingent on tolerability. Medications are not up-titrated if systolic blood pressure is \\\u003C95 mmHg, potassium is \\>5.0 mmol\u002FL, eGFR is \\\u003C30 mL\u002Fmin\u002F1.73m², or heart rate is \\\u003C55 bpm (beta-blocker only); diuretic dose reduction is encouraged if eGFR is \\\u003C30 mL\u002Fmin\u002F1.73m². Safety and tolerability are formally reassessed at weeks 2, 4, 6, 10, and 12.",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Philipp Lurz, Prof","Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Karl-Patrik Kresoja, MD","CONTACT","+49 6131 178163","Achilles-HF@unimedizin-mainz.de",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"Vera Jakobi","+49 6131 175082","Studienzentrum-ZfK@unimedizin-mainz.de",{"type":35,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Philipp Lurz","Professor of Medicine, Director of the Department of Cardiology",[50],{"name":51,"class":52},"Abbott","INDUSTRY","100651217","achieving-optimal-medical-therapy-through-percutaneous-treatment-of-secondary-mitral-regurgitation-to-improve-outcome-in-patients-with-hfref-100651217",false,"NCT07758023","Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF","ACHILLES-HF","Inclusion Criteria:\n\n1. Heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction ≤40%)\n2. Clinically significant functional mitral regurgitation (moderate-to severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization (i.e. EROA ≥0.2 cm² and\u002For regurgitant fraction \\>30%)\n3. Suboptimal GDMT therapy corresponding to a GDMT score \\\u003C7 points\n4. Risk factor for not intensification of guideline directed medical therapy (at least one of the following):\n\n   1. Office systolic blood pressure \\\u003C120 mmHG\n   2. Chronic renal failure with eGFR \\\u003C60 ml\u002Fmin\u002F1.73m\n   3. History of acute kidney injury (AKI) at least stage 2 within the last 12 months\n   4. Serum Potassium ≥ 4.8 mmol\u002FL\n5. Persisting symptoms equalling NYHA functional class II-IVa (ambulatory)\n6. Patient has had at least one HF hospitalization within 12 months and\u002For a NT-proBNP ≥1000 pg\u002Fml\n7. Interventional cardiologist believes secondary MR can be successfully treated by an interventional approach\n8. The subject has been informed of the nature of the study and agrees to the study's provisions, including the possibility of randomization to the Control group, and has provided written informed consent as approved by the respective clinical site's Ethics Committee\n\nExclusion Criteria:\n\n1. Terminal heart failure or hemodynamic instability\n2. Primary TR or MR, any other severe valvular heart disease\n3. Untreated clinically significant CAD (coronary artery disease) requiring revascularization\n4. LVEF \\\u003C35% and left bundle branch block with a QRS duration \\>150 ms\n5. Renal failure requiring dialysis\n6. Mitral valve orifice area \\\u003C4.0 cm² by site assessed TTE\n7. Life expectancy \\\u003C12 months due to non-cardiac conditions\n8. KCCQ score \\> 80 points\n9. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)\n10. Active infections requiring current antibiotic therapy.\n11. Known hypersensitivity or contraindication to procedural device which cannot be adequately managed medically.\n12. Patient is pregnant, nursing, or planning to be pregnant\n13. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator.\n14. Currently participating in another investigational therapeutic or interventional clinical trial, or in any trial of an unapproved drug, device or procedure. Note: Subjects participating in observational studies or registries may be considered as eligible.\n15. Ineligibility to consent","ALL","18 Years",{"count":63,"type":64},520,"ESTIMATED","INTERVENTIONAL",[67],"NA","The purpose of the ACHILLES-HF trial (ACHIeving optimaL medicaL therapy through pErcutaneous treatment of Secondary mitral regurgitation to improve outcome in Patients with Heart Failure with reduced ejection fraction) is to test whether early transcatheter edge-to-edge repair (TEER) in patients with heart failure and reduced ejection fraction (HFrEF) and relevant secondary mitral regurgitation, that are at risk of not receiving full guideline recommended therapy (GDMT), results in faster and more complete GDMT up-titration and whether this translates into improved quality of life and clinical outcomes.",[70,71],"Mitral Regurgitation Functional","Heart Failure With Reduced Ejection Fraction (HFrEF)",[73,74,23,75],"Mitral regurgitation","HFrEF","Guideline directed medical therapy","NOT_YET_RECRUITING","2026-08-05",{"date":79,"type":80},"2026-08-11","ACTUAL",{"date":82,"type":64},"2026-08-10",{"date":84,"type":64},"2030-09-30",{"name":5,"class":6}]