Can a cholesterol drug stop a heart valve from hardening?
NCT ID NCT07256197
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a drug called a PCSK9 inhibitor (Tafolecimab) can slow the progression of mild to moderate calcific aortic stenosis, a condition where the heart valve narrows and hardens. Researchers will give the drug to half of 160 participants and compare changes in valve function over time. The goal is to find a medication that can delay or prevent the need for valve replacement surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PCSK9 inhibitors (Tafolecimab)
- What this could lead to
- If it works, this could point toward a drug treatment to slow or prevent worsening of aortic stenosis, potentially delaying or avoiding valve surgery.
- What could go wrong
- This is a relatively small phase 3 trial (160 people) and has not started recruiting. The drug may not slow the disease, and side effects from PCSK9 inhibitors are possible.
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 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 85 years
- 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. Aged 18-85 years old, clinically diagnosed with mild or moderate CAVS (echocardiography shows ejection fraction \> 50%; valve orifice area \> 1.0 cm²; left ventricular stroke volume index \> 35 ml/m²; flow velocity ≥ 2 m/s and \< 4 m/s, or mean transvalvular pressure gradient \< 40 mmHg) and currently not requiring valve replacement therapy; 2. LDL-C ≥ 2.6 and \< 4.9 mmol/L, or Lp(a) ≥ 30 mg/dL, or receiving statin therapy due to a clinical diagnosis of hypercholesterolemia/hyperlipidemia; 3. Patients who can understand the purpose of the trial, voluntarily participate, sign the informed consent form, and are willing to undergo clinical follow-up in accordance with the trial requirements. * The position and method of measurement have been further clarified in ultrasonic measurement to ensure comparability among all enrolled patients, as follows: Aortic valve peak flow velocity, aortic valve mean pressure gradient, and valve orifice area (select images of at least 3 consecutive cardiac cycles with stable heart rate; for atrial fibrillation, select images of more than 5 consecutive cardiac cycles; obtain the peak blood flow velocity of the aortic valve orifice using continuous wave Doppler in the apical 5-chamber view; calculate the instantaneous aortic valve pressure gradient using the simplified Bernoulli equation, and calculate the standardized aortic valve orifice area using the continuity equation; all participating sonographers will receive unified training, perform measurements in fixed views and retain images, which will then be reviewed by two experienced sonographers who are blinded to the trial in the core laboratory). Exclusion Criteria: 1. Any previous treatment with PCSK9 inhibitors; 2. Patients must be treated with PCSK9 inhibitors by physician's judgment; 3. Patients who cannot maintain PCSK9 inhibitor use for 24 months; 4. Contraindications or hypersensitivity to PCSK9 inhibitors; 5. Suspected or confirmed familial hypercholesterolemia; 6. Fasting triglycerides (TG) \>400 mg/dL (4.5 mmol/L) at baseline screening; 7. Thyroid hypofunction; 8. Active or chronic liver disease; 9. Severe renal insufficiency (eGFR \<30 mL/min/1.73 m²); 10. History of intracranial hemorrhage; 11. History of alcohol or drug abuse; 12. Known active infection, or severe hematologic, metabolic, or endocrine dysfunction; 13. Systemic corticosteroid or cyclosporine therapy within the past 3 months; 14. Active malignancy; 15. Any life-threatening condition with life expectancy less than 12 months; 16. Rheumatic aortic stenosis; 17. Severe mitral stenosis (mitral valve area \<1 cm²); 18. Severe mitral or aortic regurgitation; 19. Planned cardiac valve surgery; 20. Left ventricular ejection fraction \< 30% or severe heart failure (NYHA class III or IV); 21. Implanted permanent pacemaker or cardioverter-defibrillator; 22. Drug-refractory arrhythmias; 23. Pregnancy, lactation, or planned pregnancy.
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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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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
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