Mitral Regurgitation FunctionalACHILLES-HFNCT07758023
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
A study testing M-TEER and Standardized GDMT Up-Titration in people with Mitral Regurgitation Functional and Heart Failure With Reduced Ejection Fraction (HFrEF), run by University Medical Center Mainz at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- M-TEER and Standardized GDMT Up-Titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2026to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction ≤40%)
- 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/or regurgitant fraction >30%)
- Suboptimal GDMT therapy corresponding to a GDMT score <7 points
- Risk factor for not intensification of guideline directed medical therapy (at least one of the following):
- Office systolic blood pressure <120 mmHG
- Chronic renal failure with eGFR <60 ml/min/1.73m
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- History of acute kidney injury (AKI) at least stage 2 within the last 12 months
- Serum Potassium ≥ 4.8 mmol/L
- Persisting symptoms equalling NYHA functional class II-IVa (ambulatory)
- Patient has had at least one HF hospitalization within 12 months and/or a NT-proBNP ≥1000 pg/ml
- Interventional cardiologist believes secondary MR can be successfully treated by an interventional approach
- 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
Who cannot join
- Terminal heart failure or hemodynamic instability
- Primary TR or MR, any other severe valvular heart disease
- Untreated clinically significant CAD (coronary artery disease) requiring revascularization
- LVEF <35% and left bundle branch block with a QRS duration >150 ms
- Renal failure requiring dialysis
- Mitral valve orifice area <4.0 cm² by site assessed TTE
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- Life expectancy <12 months due to non-cardiac conditions
- KCCQ score > 80 points
- Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated)
- Active infections requiring current antibiotic therapy.
- Known hypersensitivity or contraindication to procedural device which cannot be adequately managed medically.
- Patient is pregnant, nursing, or planning to be pregnant
- Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the investigator.
- 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.
- Ineligibility to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin Mainz
Mainz, Rhineland-Palatine, 55131
Karl-Patrik Kresoja, MD, +49 6131178163, karl-patrik.kresoja@unimedizin-mainz.de
About this study
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.
- Being tested
- M-TEER, Standardized GDMT Up-Titration
- Keywords
- Mitral regurgitation, HFrEF, M-TEER, Guideline directed medical therapy
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TEERDevice
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.
Standardized GDMT Up-TitrationOther
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/ARB/ARNI, 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/ARB/ARNI, and MRA targeted by week 6, contingent on tolerability. Medications are not up-titrated if systolic blood pressure is <95 mmHg, potassium is >5.0 mmol/L, eGFR is <30 mL/min/1.73m², or heart rate is <55 bpm (beta-blocker only); diuretic dose reduction is encouraged if eGFR is <30 mL/min/1.73m². Safety and tolerability are formally reassessed at weeks 2, 4, 6, 10, and 12.
| Study group | Role | What they receive |
|---|---|---|
| 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/ARB/ARNI, 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/tolerability reassessment at 2, 4, 6, 8, 10, and 12 weeks. Receives: Device: M-TEER; Other: Standardized GDMT Up-Titration |
| 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/ARB/ARNI, 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. Receives: Other: Standardized GDMT Up-Titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Guideline-Directed Medical Therapy (GDMT) Score at 12 Weeks
Between-group difference in GDMT intensity score, a 0-12 point composite scoring dosing of ACE inhibitor/ARB/ARNI, beta-blocker, mineralocorticoid receptor antagonist, and SGLT2 inhibitor relative to trial-defined target doses (0-[2]3 points per drug class). Analyzed via a mixed model for repeated measures (fixed effects for site, age group, sex, NYHA class, treatment, visit, and treatment-by-visit interaction; baseline score as covariate; first-order autoregressive covariance structure). Higher scores indicate more complete guideline-directed therapy.
Measured: Baseline and 12 weeks post-randomization (post-procedure for Intervention group)
Difference in Quality of Life (KCCQ Score) at 12 Weeks
Between-group difference in quality of life among surviving patients, assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (range 0-100, higher scores indicate better health status), from baseline to 12 weeks. Analyzed via two-sample t-test.
Measured: Baseline and 12 weeks post-randomization (post-procedure for Intervention group), among surviving patients
Composite of Cardiovascular Death or First Heart Failure Hospitalization at 24 Months
Time to the first occurrence of cardiovascular death or heart failure hospitalization within 24 months of randomization, centrally adjudicated by an independent Clinical Events Committee blinded to treatment allocation.
Measured: From randomization to 24 months
Secondary outcomes (7)
Win Ratio for Cardiovascular Mortality, First Heart Failure Hospitalization, KCCQ Improvement, or GDMT Score Improvement at 24 Months
Hierarchical composite of cardiovascular death, first heart failure hospitalization, a Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement of more than 5 points, and a GDMT score improvement of more than 2 points, ranked in that order and compared between groups using the Finkelstein-Schoenfeld win ratio method. Win ratio and 95% confidence interval reported.
Measured: From randomization to 24 months (GDMT and KCCQ improvement assessed at 12 weeks)
Total Heart Failure Hospitalizations Through 24 Months
Total number of first and recurrent heart failure hospitalizations through 24 months, with cardiovascular death analyzed as a terminal heart failure hospitalization event. Analyzed using the Lin-Wei-Yang-Ying (LWYY) model for recurrent events; treatment effect reported as a rate ratio with 95% confidence interval.
Measured: From randomization to 24 months
Mitral Regurgitation Severity at 24 Months
Proportion of subjects with residual mitral regurgitation severity of grade 2+ or less at 24 months. Analyzed by logistic regression adjusted for baseline MR grade and etiology; odds ratio and 95% confidence interval reported.
Measured: 24 months
NYHA Functional Class Improvement at 12 Months
Proportion of subjects with an improvement of at least one NYHA functional class from baseline to 12 months. Analyzed using Fisher's exact test; between-group difference in proportions reported with 95% confidence interval.
Measured: Baseline and 12 months
Change in Left Ventricular End-Diastolic Volume (LVEDV) from Baseline to 12 Months
Change in left ventricular end-diastolic volume, assessed by echocardiography, from baseline to 12 months, reflecting reverse left ventricular remodeling. Analyzed using a two-sample t-test; mean between-group difference reported with 95% confidence interval.
Measured: Baseline and 12 months
All-Cause Mortality Within 24 Months
All-cause mortality within 24 months of randomization. Analyzed using a Cox proportional hazards model stratified by country and heart failure etiology; hazard ratio and 95% confidence interval reported with Kaplan-Meier estimates.
Measured: From randomization to 24 months
Need for Mitral Valve Re-Intervention
Occurrence of mitral valve re-intervention, surgical or transcatheter, during follow-up. Analyzed using Fisher's exact test; proportion and 95% confidence interval reported for each group, along with the between-group difference.
Measured: From randomization to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start15 Oct 2026
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mitral Regurgitation FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Philipp Lurz, University Medical Center Mainz
- Investigators
- Philipp Lurz, Prof, Principal investigator, Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758023
- Sponsor's protocol ID
- 2026-18715
- Acronym
- ACHILLES-HF
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary endpoint analyses will be made available, together with the study protocol, statistical analysis plan, and informed consent form.
Publications
Anker SD, Friede T, von Bardeleben RS, Butler J, Khan MS, Diek M, Heinrich J, Geyer M, Placzek M, Ferrari R, Abraham WT, Alfieri O, Auricchio A, Bayes-Genis A, Cleland JGF, Filippatos G, Gustafsson F, Haverkamp W, Kelm M, Kuck KH, Landmesser U, Maggioni AP, Metra M, Ninios V, Petrie MC, Rassaf T, Ruschitzka F, Schafer U, Schulze PC, Spargias K, Vahanian A, Zamorano JL, Zeiher A, Karakas M, Koehler F, Lainscak M, Oner A, Mezilis N, Theofilogiannakos EK, Ninios I, Chrissoheris M, Kourkoveli P, Papadopoulos K, Smolka G, Wojakowski W, Reczuch K, Pinto FJ, Wiewiorka L, Kalarus Z, Adamo M, Santiago-Vacas E, Ruf TF, Gross M, Tongers J, Hasenfuss G, Schillinger W, Ponikowski P; RESHAPE-HF2 Investigators. Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1799-1809. doi: 10.1056/NEJMoa2314328. Epub 2024 Aug 31.
PubMed 39216092Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
PubMed 30280640Packer M, Metra M. Guideline-directed medical therapy for heart failure does not exist: a non-judgmental framework for describing the level of adherence to evidence-based drug treatments for patients with a reduced ejection fraction. Eur J Heart Fail. 2020 Oct;22(10):1759-1767. doi: 10.1002/ejhf.1857. Epub 2020 May 20.
PubMed 32432391Adamo M, Tomasoni D, Stolz L, Stocker TJ, Pancaldi E, Koell B, Karam N, Besler C, Giannini C, Sampaio F, Praz F, Ruf T, Pechmajou L, Neuss M, Iliadis C, Baldus S, Butter C, Kalbacher D, Lurz P, Melica B, Petronio AS, von Bardeleben RS, Windecker S, Butler J, Fonarow GC, Hausleiter J, Metra M. Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Guideline-Directed Medical Therapy Uptitration. JACC Cardiovasc Interv. 2023 Apr 24;16(8):896-905. doi: 10.1016/j.jcin.2023.01.362. Epub 2023 Mar 22.
PubMed 37100553Kresoja KP, Adamo M, Rommel KP, Stolz L, Karam N, Giannini C, Melica B, von Bardeleben RS, Butter C, Horn P, Praz F, Kalbacher D, Iliadis C, Thiele H, Hausleiter J, Metra M, Lurz P. Guideline-directed medical therapy assessment in heart failure patients undergoing percutaneous mitral valve repair. ESC Heart Fail. 2024 Jun;11(3):1802-1807. doi: 10.1002/ehf2.14705. Epub 2024 Feb 13.
PubMed 38351672
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
- ClinicalTrials.gov ID
- NCT07758023
- Acronym / sponsor ID
- ACHILLES-HF / 2026-18715
- Keywords
- Mitral regurgitation, HFrEF, M-TEER, Guideline directed medical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- University Medical Center MainzUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: M-TEER, Other: Standardized GDMT Up-TitrationSubjects 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/ARB/ARNI, 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/tolerability reassessment at 2, 4, 6, 8, 10, and 12 weeks. |
| Control group | Active comparator | Other: Standardized GDMT Up-TitrationSubjects 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/ARB/ARNI, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction ≤40%)
- 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/or regurgitant fraction >30%)
- Suboptimal GDMT therapy corresponding to a GDMT score <7 points
- Risk factor for not intensification of guideline directed medical therapy (at least one of the following):
- Persisting symptoms equalling NYHA functional class II-IVa (ambulatory)
Key exclusion criteria (15 listed)
- Terminal heart failure or hemodynamic instability
- Primary TR or MR, any other severe valvular heart disease
- Untreated clinically significant CAD (coronary artery disease) requiring revascularization
- LVEF <35% and left bundle branch block with a QRS duration >150 ms
- Renal failure requiring dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M-TEERTranscatheter edge-to-edge repair (M-TEER) of the mitral valve, performed once, within 7 days of randomization, in subjects randomized to the Intervention arm. | Device | Intervention group |
| Standardized GDMT Up-TitrationA 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/ARB/ARNI, 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/ARB/ARNI, and MRA targeted by week 6, contingent on tolerability. Medications are not up-titrated if systolic blood pressure is <95 mmHg, potassium is >5.0 mmol/L, eGFR is <30 mL/min/1.73m², or heart rate is <55 bpm (beta-blocker only); diuretic dose reduction is encouraged if eGFR is <30 mL/min/1.73m². Safety and tolerability are formally reassessed at weeks 2, 4, 6, 10, and 12. | Other | Control group, Intervention group |
Primary outcome
Difference in Guideline-Directed Medical Therapy (GDMT) Score at 12 Weeks
Time frame: Baseline and 12 weeks post-randomization (post-procedure for Intervention group)
Between-group difference in GDMT intensity score, a 0-12 point composite scoring dosing of ACE inhibitor/ARB/ARNI, beta-blocker, mineralocorticoid receptor antagonist, and SGLT2 inhibitor relative to trial-defined target doses (0-[2]3 points per drug class). Analyzed via a mixed model for repeated measures (fixed effects for site, age group, sex, NYHA class, treatment, visit, and treatment-by-visit interaction; baseline score as covariate; first-order autoregressive covariance structure). Higher scores indicate more complete guideline-directed therapy.
Difference in Quality of Life (KCCQ Score) at 12 Weeks
Time frame: Baseline and 12 weeks post-randomization (post-procedure for Intervention group), among surviving patients
Between-group difference in quality of life among surviving patients, assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (range 0-100, higher scores indicate better health status), from baseline to 12 weeks. Analyzed via two-sample t-test.
Composite of Cardiovascular Death or First Heart Failure Hospitalization at 24 Months
Time frame: From randomization to 24 months
Time to the first occurrence of cardiovascular death or heart failure hospitalization within 24 months of randomization, centrally adjudicated by an independent Clinical Events Committee blinded to treatment allocation.
7 secondary outcomes
Win Ratio for Cardiovascular Mortality, First Heart Failure Hospitalization, KCCQ Improvement, or GDMT Score Improvement at 24 Months
Time frame: From randomization to 24 months (GDMT and KCCQ improvement assessed at 12 weeks)
Total Heart Failure Hospitalizations Through 24 Months
Time frame: From randomization to 24 months
Mitral Regurgitation Severity at 24 Months
Time frame: 24 months
NYHA Functional Class Improvement at 12 Months
Time frame: Baseline and 12 months
Change in Left Ventricular End-Diastolic Volume (LVEDV) from Baseline to 12 Months
Time frame: Baseline and 12 months
All-Cause Mortality Within 24 Months
Time frame: From randomization to 24 months
Need for Mitral Valve Re-Intervention
Time frame: From randomization to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 39216092Anker SD, Friede T, von Bardeleben RS, Butler J, Khan MS, Diek M, Heinrich J, Geyer M, Placzek M, Ferrari R, Abraham WT, Alfieri O, Auricchio A, Bayes-Genis A, Cleland JGF, Filippatos G, Gustafsson F, Haverkamp W, Kelm M, Kuck KH, Landmesser U, Maggioni AP, Metra M, Ninios V, Petrie MC, Rassaf T, Ruschitzka F, Schafer U, Schulze PC, Spargias K, Vahanian A, Zamorano JL, Zeiher A, Karakas M, Koehler F, Lainscak M, Oner A, Mezilis N, Theofilogiannakos EK, Ninios I, Chrissoheris M, Kourkoveli P, Papadopoulos K, Smolka G, Wojakowski W, Reczuch K, Pinto FJ, Wiewiorka L, Kalarus Z, Adamo M, Santiago-Vacas E, Ruf TF, Gross M, Tongers J, Hasenfuss G, Schillinger W, Ponikowski P; RESHAPE-HF2 Investigators. Transcatheter Valve Repair in Heart Failure with Moderate to Severe Mitral Regurgitation. N Engl J Med. 2024 Nov 14;391(19):1799-1809. doi: 10.1056/NEJMoa2314328. Epub 2024 Aug 31.
- Background: PubMed 30280640Stone GW, Lindenfeld J, Abraham WT, Kar S, Lim DS, Mishell JM, Whisenant B, Grayburn PA, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Weissman NJ, Mack MJ; COAPT Investigators. Transcatheter Mitral-Valve Repair in Patients with Heart Failure. N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
- Background: PubMed 32432391Packer M, Metra M. Guideline-directed medical therapy for heart failure does not exist: a non-judgmental framework for describing the level of adherence to evidence-based drug treatments for patients with a reduced ejection fraction. Eur J Heart Fail. 2020 Oct;22(10):1759-1767. doi: 10.1002/ejhf.1857. Epub 2020 May 20.
- Background: PubMed 37100553Adamo M, Tomasoni D, Stolz L, Stocker TJ, Pancaldi E, Koell B, Karam N, Besler C, Giannini C, Sampaio F, Praz F, Ruf T, Pechmajou L, Neuss M, Iliadis C, Baldus S, Butter C, Kalbacher D, Lurz P, Melica B, Petronio AS, von Bardeleben RS, Windecker S, Butler J, Fonarow GC, Hausleiter J, Metra M. Impact of Transcatheter Edge-to-Edge Mitral Valve Repair on Guideline-Directed Medical Therapy Uptitration. JACC Cardiovasc Interv. 2023 Apr 24;16(8):896-905. doi: 10.1016/j.jcin.2023.01.362. Epub 2023 Mar 22.
- Background: PubMed 38351672Kresoja KP, Adamo M, Rommel KP, Stolz L, Karam N, Giannini C, Melica B, von Bardeleben RS, Butter C, Horn P, Praz F, Kalbacher D, Iliadis C, Thiele H, Hausleiter J, Metra M, Lurz P. Guideline-directed medical therapy assessment in heart failure patients undergoing percutaneous mitral valve repair. ESC Heart Fail. 2024 Jun;11(3):1802-1807. doi: 10.1002/ehf2.14705. Epub 2024 Feb 13.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary endpoint analyses will be made available, together with the study protocol, statistical analysis plan, and informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Philipp Lurz, Prof principal investigator
Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M-TEER and Standardized GDMT Up-Titration in people with Mitral Regurgitation Functional and Heart Failure With Reduced Ejection Fraction (HFrEF), run by University Medical Center Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl-Patrik Kresoja, MD (+49 6131 178163, Achilles-HF@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Guideline-Directed Medical Therapy (GDMT) Score at 12 Weeks (time frame: Baseline and 12 weeks post-randomization (post-procedure for Intervention group)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07758023, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.