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Could a common supplement protect the failing heart? a major trial puts Alpha-Lipoic acid to the test

NCT ID NCT07725484

Disease control Sponsor: Shanghai Zhongshan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 24, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This trial investigates whether a daily dose of alpha-lipoic acid, a vitamin-like antioxidant, can lower the risk of major heart problems in people with chronic heart failure caused by coronary artery disease. Researchers will compare the supplement against a placebo in over 1,500 adults aged 18 to 75 with reduced heart pumping function. The goal is to see if this simple addition to standard care can reduce heart-related deaths, hospitalizations, strokes, and heart attacks over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a vitamin-like supplement called alpha-lipoic acid (ALA), taken as a 600 mg daily pill
What this could lead to
If it works, this could offer a simple, low-cost add-on treatment to reduce the risk of heart-related death and hospital stays for people with heart failure.
What could go wrong
This is a large phase 3 trial, but earlier evidence was exploratory. The supplement may not provide significant benefit over standard care, and any effect may be modest.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,526 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18 years or older and younger than 75 years at the time of enrollment. * A history of chronic heart failure for more than 3 months, or clinical symptoms of heart failure lasting more than 3 months, diagnosed according to the 2023 European Society of Cardiology guidelines for the diagnosis and treatment of chronic heart failure. * Left ventricular ejection fraction (LVEF) of 40% or less, as assessed by echocardiography. * A history of acute myocardial infarction more than 3 months prior to enrollment, diagnosed according to the Fourth Universal Definition of Myocardial Infarction. * New York Heart Association (NYHA) functional class II to IV, with stable clinical symptoms. * Receipt of guideline-directed medical therapy for heart failure for at least 2 weeks, without dose adjustment or intravenous therapy during this period. Guideline-directed medical therapy includes: Angiotensin-converting enzyme inhibitors (ACEIs), or Angiotensin receptor blockers (ARBs), or Angiotensin receptor-neprilysin inhibitors (ARNIs), Beta-blockers, and Mineralocorticoid receptor antagonists,unless contraindicated or not tolerated, and prescribed at optimal tolerated doses. * Ability and willingness to understand the study procedures and provide written informed consent. Exclusion Criteria: * Prior cardiac resynchronization therapy (CRT). * Severe hepatic dysfunction, defined as liver transaminase levels greater than three times the upper limit of normal, or severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m². * Presence of uncontrolled malignant arrhythmias or progressively worsening unstable angina. * Presence of malignancy, lymphoma, leukemia, or other serious diseases with an expected life expectancy of less than 1 year. * Participation in another investigational drug study within 4 weeks prior to enrollment, or current receipt of any investigational treatment other than the study intervention. * Pregnant or breastfeeding women. * Known allergy to vitamin B-related medications.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure due to coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    21 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272029, China

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning, China

  • Fujian provincial hospital

    Fuzhou, Fujian, 35000, China

  • Guangdong Provincial People's Hospital

    Guangdong, China

  • Luoyang Central Hospital Affiliated to Zhengzhou University

    Luoyang, Henan, 471009, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

  • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 201700, China

  • Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University)

    Quzhou, Zhejiang, 324000, China

  • Shanghai East Hospital, Tongji University School of Medicine

    Shanghai, Shanghai Municipality, 200120, China

  • Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital

    Shanghai, Shanghai Municipality, 200237, China

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, 030024, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000, China

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, China

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui, 230001, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001, China

  • Wusong Hospital, Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200940, China

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009, China

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032, China

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