New infusion drug aims to keep severe heart failure patients out of hospital
NCT ID NCT00610051
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial tests whether a continuous infusion of alprostadil, a drug that widens blood vessels, can help maintain stability in 600 people with advanced heart failure. Participants receive either the drug or a placebo for 6 months. The main goal is to see if the drug reduces deaths, need for heart transplant or mechanical support, and heart failure-related hospitalizations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- alprostadil (a drug that widens blood vessels, given as a continuous infusion)
- What this could lead to
- If it works, this could provide a new way to keep severe heart failure patients stable and reduce the need for hospitalization or emergency treatment.
- What could go wrong
- This is still an experimental treatment, and it requires a continuous infusion through a central line, which carries infection and complication risks. The trial is not yet recruiting, so results are years away.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 600 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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.
1. Patients older than 18 years of age, of any gender/sex and race/ethnicity 2. Patients with a diagnosis of advanced HFrEF as evidenced by (all must apply): 1. most recent LVEF( by conventional imaging method\<30% which was mwasured within 3 months prior randomization. 2. Nt-proBNP \>1500 ng/L or BNP \>300 ng/L at prior randomization 3. New York Heart Association (NYHA) functional class IIIb or IV, i.e., chronic dyspnoea or fatigue at rest or with minimal exertion for at least one month prior to consent. 4. Renal dysfunction reflected by a glomerular filtration rate (GFR) \<60 mL/min approximated by the Modification of Diet in Renal Disease formula. 5. A total symptom score of KCCQ of \<70measure within 24 hours of randomization 6. Patients on all appropriate recommended HF therapy. 3. Patient should not be receiving continuous or planned intermittent intravenous infusions with a positive inotropic or vasodilator drug in a non-hospitalized setting 4. Patients should not be considered as candidates for heart transplantation or LVAD for at least 6 months from randomization according to the opinion of the treating physician. 5. Women of childbearing potential (i.e., who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must commit either to abstain continuously from heterosexual sexual contact or to use at least one "highly effective" method of birth control (e.g., intrauterine device \[IUD\], hormonal contraception, tubal ligation, or partner's vasectomy) or two "effective" methods (e.g., latex condom, diaphragm, or cervical cap), beginning 4 weeks prior to screening and throughout study participation. Note: As alprostadil is not genotoxic and female sexual partners of male study participants are not likely to have substantial exposure via semen, there are no contraception requirements for men. 6. Patients must be willing and able to give written informed consent, including local data privacy consents, as required
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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
1 site. 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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Medical university Vienna
Vienna, Austria
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Other studies related to the condition(s) this trial covers.
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