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Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients

21. Juli 2026 aktualisiert von: Xu Lei, Shanghai Zhongshan Hospital

Lipoic Acid in Chronic Ischemic Heart Failure: Assessment of Reduction in Major Adverse Cardiovascular Events

Chronic heart failure is a clinical condition caused by structural heart disease and is characterized by reduced pumping function, fluid retention, and abnormal activation of neurohormonal systems. It represents the advanced stage of many cardiovascular diseases and remains a major global health challenge. Despite progress in medical and interventional therapies, patients with chronic heart failure continue to experience high rates of death, hospitalization, and long-term disability.

Ischemic heart failure, which develops as a result of coronary artery disease and prior myocardial infarction, is the most common form of chronic heart failure. Current treatment strategies, including guideline-directed medical therapy and revascularization procedures, can improve symptoms and outcomes but do not fully address the residual risk of adverse cardiovascular events. Therefore, additional therapeutic approaches are needed to further improve long-term prognosis in this population.

Abnormal myocardial energy metabolism is a key pathological feature of heart failure. Mitochondria play a central role in energy production, and impaired mitochondrial function contributes to disease progression. Previous studies by our group have identified mitochondrial aldehyde dehydrogenase 2 (ALDH2) as an important regulator of myocardial metabolic homeostasis and cardiac protection under ischemic and stress conditions.

Alpha-lipoic acid is a vitamin B-related compound with antioxidant properties and has been widely used in clinical practice for other indications. Increasing evidence suggests that alpha-lipoic acid may also exert protective effects in cardiovascular diseases, potentially through modulation of mitochondrial function. Experimental studies have shown that alpha-lipoic acid can restore ALDH2 activity and improve cardiac function in models of heart failure.

Based on these findings, we conducted an exploratory randomized controlled trial between 2019 and 2023 to evaluate the safety and potential efficacy of alpha-lipoic acid in patients with ischemic heart failure. In this multicenter study, patients receiving alpha-lipoic acid showed favorable trends toward reduced risk of death and heart failure-related hospitalization, as well as significant improvements in left ventricular ejection fraction and exercise capacity, without an increase in adverse events.

Taken together, prior mechanistic research and early clinical evidence support the hypothesis that alpha-lipoic acid may provide additional benefit when used as adjunctive therapy in patients with chronic ischemic heart failure. The present study is designed to further evaluate whether long-term supplementation with alpha-lipoic acid can reduce major adverse cardiovascular events and improve clinical outcomes in this population.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

1526

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
      • Dalian, China
        • The First Affiliated Hospital of Dalian Medical University
        • Kontakt:
      • Guangdong, China
        • Guangdong Provincial People's Hospital
        • Kontakt:
    • Anhui
      • Hefei, Anhui, China, 230001
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • Kontakt:
    • Fujian
      • Fuzhou, Fujian, China, 35000
        • Fujian Provincial Hospital
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The First affiliated hospital, Sun Yat-sen University
        • Kontakt:
    • Henan
      • Luoyang, Henan, China, 471009
        • Luoyang Central Hospital Affiliated to Zhengzhou University
        • Kontakt:
      • Zhengzhou, Henan, China, 450052
        • The First Affiliated Hospital of Zhengzhou University
        • Kontakt:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital, Southeast University
        • Kontakt:
    • Liaoning
      • Dalian, Liaoning, China
        • Affiliated Zhongshan Hospital of Dalian University
        • Kontakt:
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Kontakt:
    • Shandong
      • Jinan, Shandong, China, 250012
        • QiLu Hospital of ShanDong University
        • Kontakt:
          • Xiaoping Ji
          • Telefonnummer: +86-531-82169400
          • E-Mail: jxp64@163.com
      • Jining, Shandong, China, 272029
        • Affiliated Hospital of Jining Medical University
        • Kontakt:
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University
        • Kontakt:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
      • Shanghai, Shanghai Municipality, China, 200120
        • Shanghai East Hospital, Tongji University School of Medicine
        • Kontakt:
      • Shanghai, Shanghai Municipality, China, 200237
        • Shanghai Xuhui Central Hospital, Zhongshan-Xuhui Hospital
        • Kontakt:
      • Shanghai, Shanghai Municipality, China, 200940
        • Wusong Hospital, Zhongshan Hospital, Fudan University
        • Kontakt:
      • Shanghai, Shanghai Municipality, China, 201700
        • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
        • Kontakt:
    • Shanxi
      • Taiyuan, Shanxi, China, 030024
        • Shanxi Cardiovascular Hospital
        • Kontakt:
      • Taiyuan, Shanxi, China, 030001
        • The Second Hospital of Shanxi Medical University
        • Kontakt:
    • Zhejiang
      • Quzhou, Zhejiang, China, 324000
        • Quzhou People's Hospital (Quzhou Affiliated Hospital of Wenzhou Medical University)
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Placebo-Komparator: Placebo-Gruppe
Arzneimittel: placebo
After enrollment, patients received placebo drug at a dose of 600 mg per day for 24 months.
Experimental: Alpha-Lipoic Acid (ALA)
Arzneimittel: Alpha-Lipoic Acid (ALA)
After enrollment, patients received Alpha-Lipoic Acid drug at a dose of 600 mg per day for 24 months.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Major Adverse Cardiovascular Events (MACE)
Zeitfenster: From enrollment to the end of treatment at 24 months.
Major adverse cardiovascular events (MACE) are defined as a composite outcome that includes cardiovascular death, hospitalization for heart failure, non-fatal stroke, and non-fatal myocardial infarction occurring during the follow-up period. The primary outcome is the occurrence of the first MACE event during follow-up, identified using standard clinical criteria and confirmed through medical records.
From enrollment to the end of treatment at 24 months.
Hospitalization for Heart Failure
Zeitfenster: From enrollment to the end of treatment at 24 months.
Unplanned admission to the hospital due to worsening heart failure symptoms that require intravenous treatment or intensified medical care during follow-up.
From enrollment to the end of treatment at 24 months.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Hospitalization for Heart Failure
Zeitfenster: From enrollment to the end of treatment at 24 months.
Unplanned hospitalization due to worsening heart failure symptoms occurring during the follow-up period.
From enrollment to the end of treatment at 24 months.
Non-fatal Stroke
Zeitfenster: From enrollment to the end of treatment at 24 months.
A new stroke event that does not result in death, diagnosed based on clinical symptoms and imaging findings, occurring during the follow-up period.
From enrollment to the end of treatment at 24 months.
Non-fatal Myocardial Infarction
Zeitfenster: From enrollment to the end of treatment at 24 months.
A new myocardial infarction that does not result in death, diagnosed according to standard clinical criteria, occurring during the follow-up period.
From enrollment to the end of treatment at 24 months.
All-cause Mortality
Zeitfenster: From enrollment to the end of treatment at 24 months.
Death from any cause occurring during the follow-up period.
From enrollment to the end of treatment at 24 months.
Change in Left Ventricular Ejection Fraction (LVEF)
Zeitfenster: From enrollment to the end of treatment at 24 months.
Change in left ventricular ejection fraction from baseline to 24 months after randomization, measured by echocardiography.
From enrollment to the end of treatment at 24 months.
Change in 6-Minute Walk Distance (6MWD)
Zeitfenster: From enrollment to the end of treatment at 24 months.
Change in the distance walked during the 6-minute walk test from baseline to 24 months after randomization.
From enrollment to the end of treatment at 24 months.
Change in NT-proBNP Level
Zeitfenster: From enrollment to the end of treatment at 24 months.
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels from baseline to 24 months after randomization.
From enrollment to the end of treatment at 24 months.
Change in Quality of Life Score (KCCQ)
Zeitfenster: From enrollment to the end of treatment at 24 months.
Change in quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 24 months after randomization.
From enrollment to the end of treatment at 24 months.
Unplanned Coronary Revascularization
Zeitfenster: From enrollment to the end of treatment at 24 months.
Unplanned coronary revascularization due to acute myocardial ischemia during follow-up, including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). This outcome is defined as a binary event.
From enrollment to the end of treatment at 24 months.
Heart Transplantation
Zeitfenster: From enrollment to the end of treatment at 24 months.
Occurrence of orthotopic heart transplantation performed as definitive treatment for end-stage heart failure during the follow-up period. This outcome is defined as a binary event.
From enrollment to the end of treatment at 24 months.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Shanghai Zhongshan Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. August 2030

Studienabschluss (Geschätzt)

1. Oktober 2030

Studienanmeldedaten

Zuerst eingereicht

21. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juli 2026

Zuerst gepostet (Tatsächlich)

24. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • KY2026037

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Deidentified individual participant data will not be made publicly available because the study includes sensitive clinical and genetic information, and no mechanism or participant consent for sharing data with external researchers has been established. Aggregate study results will be disseminated through ClinicalTrials.gov and peer-reviewed publications.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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Bedingungen

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