A Phase 2 interventional study of LDE-Paclitaxel and Placebo (LDE) in Heart Transplant Recipient and Cardiac Allograft Vasculopathy, sponsored by University of Sao Paulo General Hospital. Active, not recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by University of Sao Paulo General Hospital · Phase 2, Interventional, and Treatment
This pilot study evaluates the safety and feasibility of paclitaxel carried in cholesterol-rich lipid nanoparticles (LDE-paclitaxel) in heart transplant recipients with cardiac allograft vasculopathy (CAV). Changes in coronary atherosclerosis measured by intravascular ultrasound (IVUS) are assessed as secondary outcomes.
Cardiac allograft vasculopathy (CAV) is a leading cause of late graft failure and death after heart transplantation and has no effective pharmacological treatment. LDE is a cholesterol-rich lipid nanoemulsion that binds to LDL receptors and concentrates in tissues with high receptor expression. In a rabbit heterotopic heart transplant model, LDE-paclitaxel reduced coronary stenosis and macrophage infiltration of the graft without observable toxicity. LDE-paclitaxel (175 mg/m²) was previously well tolerated in patients with breast and ovarian cancer and in patients with aortic atherosclerosis.
In this single-center, randomized (1:1), quadruple-blind, placebo-controlled pilot study, adult heart transplant recipients more than 1 year after transplantation with angiographically documented CAV receive six intravenous infusions, every 3 weeks, of LDE-paclitaxel (paclitaxel 175 mg/m² body surface area) or LDE without paclitaxel (placebo), each infused over 2 hours without premedication. Coronary angiography and IVUS of up to three epicardial vessels are performed at baseline and approximately 1 month after the sixth infusion, and IVUS analyses are performed in matched segments by an analyst blinded to treatment allocation. Laboratory safety tests are performed before each infusion, and participants are followed clinically for 12 months after the follow-up angiography.
The protocol planned 24 participants (20 plus 20% anticipated losses); 22 were enrolled.
University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Paclitaxel 175 mg/m² body surface area carried in LDE, intravenous infusion over 2 hours, every 3 weeks for 6 cycles.
Drug: LDE-Paclitaxel
LDE without paclitaxel, intravenous infusion over 2 hours, every 3 weeks for 6 cycles.
Drug: Placebo (LDE)
Paclitaxel oleate incorporated into a cholesterol-rich lipid nanoemulsion (LDE), 175 mg/m² IV over 2 hours every 3 weeks, 6 infusions.
Lipid nanoemulsion (LDE) without paclitaxel, identical in appearance, IV over 2 hours every 3 weeks, 6 infusions.
Feasibility - strict protocol completion
Proportion of randomized participants who (i) receive all 6 study infusions, each within ±7 days of the scheduled date, AND (ii) undergo follow-up coronary angiography/IVUS within ±14 days of the scheduled date, with at least one vessel with analyzable IVUS at both baseline and follow-up.
Time frame: From the first infusion through follow-up angiography/IVUS (approximately 1 month after the 6th infusion; about 5 months)
Safety - serious or grade ≥3 adverse events related to study drug
Proportion of participants with at least one adverse event of grade ≥3 according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or at least one serious adverse event, considered at least possibly related to the study drug.
Time frame: From baseline angiography/IVUS through 30 days after the last infusion or 7 days after follow-up angiography/IVUS, whichever is later (about 5 months)
Feasibility - pragmatic protocol completion
Proportion of randomized participants meeting the strict feasibility criteria, except that a single isolated infusion delay beyond ±7 days is allowed.
Time frame: From the first infusion through follow-up angiography/IVUS (approximately 1 month after the 6th infusion; about 5 months)
Adverse events by grade, seriousness and relatedness
Number of adverse events and proportion of participants with at least one adverse event, classified by CTCAE v5.0 grade, seriousness (serious adverse event criteria) and relatedness to the study drug.
Time frame: From baseline angiography/IVUS through 12 months after follow-up angiography/IVUS (about 17 months)
Treated acute rejection
Proportion of participants with acute cellular or antibody-mediated rejection that required treatment, irrespective of relatedness to the study drug.
Time frame: From baseline angiography/IVUS through 12 months after follow-up angiography/IVUS (about 17 months)
Clinically relevant infection
Proportion of participants with infection requiring systemic antimicrobial (antibacterial, antifungal or antiviral) therapy and/or hospitalization.
Time frame: From baseline angiography/IVUS through 12 months after follow-up angiography/IVUS (about 17 months)
Change in percent atheroma volume (PAV)
Absolute change in PAV (percentage points) from baseline to follow-up IVUS. PAV = 100 × Σ plaque volume / Σ external elastic membrane (EEM) volume, with volumes summed across matched segments of all vessels with analyzable IVUS at both time points.
Time frame: Baseline and follow-up IVUS (approximately 1 month after the 6th infusion; about 5 months)
Change in normalized total atheroma volume (TAVnorm)
Change in TAVnorm (mm³) from baseline to follow-up IVUS. TAVnorm = (Σ plaque area / number of analyzed frames) × median number of analyzed frames in the study population, to adjust for differing analyzed segment lengths.
Time frame: Baseline and follow-up IVUS (approximately 1 month after the 6th infusion; about 5 months)
Change in maximal intimal thickness (MIT)
Change in MIT (mm) from baseline to follow-up IVUS, using for each participant the largest MIT among vessels with analyzable IVUS at both time points.
Time frame: Baseline and follow-up IVUS (approximately 1 month after the 6th infusion; about 5 months)
Change in minimal lumen area (MLA)
Change in MLA (mm²) from baseline to follow-up IVUS, per vessel with analyzable IVUS at both time points.
Time frame: Baseline and follow-up IVUS (approximately 1 month after the 6th infusion; about 5 months)
Angiographic cardiac allograft vasculopathy grade
CAV grade according to the International Society for Heart and Lung Transplantation (ISHLT) 2010 standardized nomenclature, assessed on coronary angiography at baseline and follow-up.
Time frame: Baseline and follow-up angiography (approximately 1 month after the 6th infusion; about 5 months)
Change in left ventricular ejection fraction (exploratory)
Change in left ventricular ejection fraction (%) between routine clinical transthoracic echocardiograms performed closest to baseline and to follow-up angiography. Echocardiography was not protocol-mandated.
Time frame: Baseline (closest routine echocardiogram) to follow-up (closest routine echocardiogram to follow-up angiography; about 5 months)
Plan to share: Undecided — A decision on sharing de-identified individual participant data will be made after confirmation with the ethics committee, as participant consent did not explicitly address data sharing.
Ran from May 2023 to primary completion in Apr 2026, 35 months.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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