Evaluating HeartMate III for treating end-stage heart failure

Swedish Evaluation of Left Ventricular Assist Device

This study is testing if the HeartMate III device can help people with end-stage heart failure live longer compared to those getting standard medical care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vastra Gotaland Region (other gov)
• Locations: 7 sites (Gothenburg and 6 other locations)
• Trial ID: NCT02592499 on ClinicalTrials.gov

What this trial studies

This study is a prospective, randomized, non-blinded, multi-center trial aimed at comparing the survival rates of patients with end-stage heart failure receiving either the HeartMate III left ventricular assist device or optimal medical management. A total of 80 patients will be enrolled and randomly assigned to one of the two treatment groups. The primary focus is on survival outcomes, while secondary objectives include assessing organ function, quality of life, and adverse events over a follow-up period of up to 5 years. The study will take place across 7 university hospitals in Sweden.

Who should consider this trial

Good fit: Ideal candidates are adults with chronic heart failure, a left ventricular ejection fraction of 30% or less, and who are ineligible for cardiac transplantation.

Not a fit: Patients with heart failure who are not considered suitable for the study by a multidisciplinary team or who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that significantly improves survival rates for patients with end-stage heart failure who are not candidates for heart transplantation.

How similar studies have performed: Previous studies have shown promising results with left ventricular assist devices in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent
2. Adult (≥ 18 years)
3. Chronic heart failure ≥ 45 days or stable not supported by mechanical circulatory support since \>7days on single inotrope.
4. Left ventricular ejection fraction ≤ 30%.
5. NYHA IIIB-IV, INTERMACS profile 2-6
6. At least 2 of 4 adverse prognostic criteria:

   * SHFM estimated 1-year survival ≤75%
   * NTproBNP ≥ 2000 ng/l
   * VO2 max \< 14 ml/kg/min or \<50% of predicted VO2max with attainment of anaerobic threshold (AT), or unable to perform.
   * Need for continuous or intermittent inotropic support or \>2 hospitalizations during last 6 months.
7. Receiving medical management with optimal doses of betablockers, ACE-inhibitors or ARBs, and MRAs for at least 30 days if tolerated.
8. Receiving CRT if indicated for at least 45 days.
9. Receiving ICD if indicated and appropriate.
10. Ineligible for cardiac transplantation (e.g. high age and/or co-morbidities)
11. Considered suitable for the study by a multidisciplinary board

Exclusion Criteria:

1. Eligible for heart transplantation or is likely to become eligible after VAD treatment (bridge-to-candidacy)
2. Indication for revascularisation, valvular surgery or other cardiac intervention expected to improve cardiac function and prognosis (CABG, PCI TAVI, mitraclip etc.)
3. INTERMACS profile 1 "crash and burn"
4. On-going mechanical circulatory support.
5. Heart failure due to restrictive cardiomyopathy pericardial disease, active myocarditis or uncorrected thyroid disease.
6. Mechanical aortic valve that will not be converted to a bioprosthesis or patch
7. Moderate to severe aortic insufficiency without plans for correction
8. Technical obstacles, which pose an inordinately high surgical risk
9. Active, uncontrolled infection

11. Stroke within 90 days or carotid artery stenosis \> 80 % 12. Significant vascular disease. 13. Severe COPD or severe restrictive lung disease. 14. Intrinsic hepatic disease as defined by liver enzyme values (AST or ALT or total bilirubin) \> 5 times the upper limit of normal, or INR \> 2.0, which is not due to anti-coagulant therapy.

15. Intolerance to anticoagulant or antiplatelet therapies or any other operative therapy the patient will require based upon the patient's health status.

16. Platelet count \< 50,000. 17. Measured GFR \<20 ml/min/1.73m2 unresponsive to inotrope treatment or chronic dialysis.

18. High risk for right ventricular failure according to echocardiography and/or invasive hemodynamic measurements as judged by the investigator (\>2 parameter constitute an exclusion criteria) using a combination of the:

a. Severe TI b. TAPSE \< 0.72 cm c. RVEDD/LVEDD \> 0.72 d. CVP \> 16 mm Hg e. MPAP - RAP \< 10 mmHg SPAP-DPAP/CVPm \>1 ok, \<0.5 very bad, in between borderline f. CVP/PCWP \> 0.63 g. RVSWI \< 300 mm Hg x ml/m2 h. Bilirubin \> 34 micromol/L 19. Body Mass Index (BMI) \> 42 kg/m2. 20. Psychiatric disease, cognitive dysfunction, alcohol or drug abuse, or psychosocial issues that are likely to impair study compliance 21. Female of childbearing age with a positive pregnancy test or not willing to use adequate contraceptive precautions during the study.

22. Condition, other than heart failure, that could limit survival to less than 2 years.

Where this trial is running

Gothenburg and 6 other locations

• Sahlgrenska Univesitetssjukhustet, Transplantationscentrum — Gothenburg, Sweden (RECRUITING)
• Linköping Univ Hospital — Linköping, Sweden (RECRUITING)
• Skåne University Hospital — Lund, Sweden (RECRUITING)
• Karolinska Univ Hospital — Stockholm, Sweden (RECRUITING)
• Univ Hospital of Umeå — Umeå, Sweden (RECRUITING)
• Uppsala Univ Hospital — Uppsala, Sweden (RECRUITING)
• Örebro Univ Hospital — Örebro, Sweden (RECRUITING)

Study contacts

• Principal investigator: Kristjan Karason, MD — Vastra Gotaland Region
• Study coordinator: Göran Dellgren, MD

Conditions: End-stage Heart Failure, HM III, survival, LVAD