Heart pump vs. pills: which keeps End-Stage heart failure patients alive longer?
NCT ID NCT02592499
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study tests whether a mechanical heart pump called the HeartMate III (an LVAD) helps people with end-stage heart failure live longer and with fewer strokes compared to taking standard heart failure medications. About 80 adults with severe heart failure are randomly assigned to receive either the pump or optimized drug therapy. The main goal is to see who survives at two years, and the study also tracks strokes and hospitalizations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HeartMate III left ventricular assist device (LVAD)
- What this could lead to
- If successful, this could show that an LVAD improves survival and reduces disabling strokes compared to medication alone for people with end-stage heart failure.
- What could go wrong
- This is a relatively small, non-blinded study, so results may not be definitive. LVADs carry risks like infection, bleeding, and device malfunction.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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74 people
The number who actually took part.
- Started
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Jun 2016
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
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: 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.
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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
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Karolinska Univ Hospital
Stockholm, Sweden
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Linköping Univ Hospital
Linköping, Sweden
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Sahlgrenska Univesitetssjukhustet, Transplantationscentrum
Gothenburg, 41234, Sweden
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Skåne University Hospital
Lund, Sweden
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Univ Hospital of Umeå
Umeå, Sweden
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Uppsala Univ Hospital
Uppsala, Sweden
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Örebro Univ Hospital
Örebro, Sweden
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