Study of AB-1002 gene therapy given through coronary arteries in adults with severe (NYHA Class III) heart failure caused by non-ischemic cardiomyopathy

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What is this study about?

This study focuses on patients with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure, a condition where the heart muscle becomes weak and enlarged, making it difficult to pump blood effectively throughout the body. The research evaluates a new gene therapy called AB-1002, which is given as a single injection directly into the heart’s arteries.

The purpose of this research is to determine how well AB-1002 works and how safe it is compared to placebo in treating heart failure. The treatment involves a one-time delivery of the medication through intracoronary infusion, which means the medicine is administered directly into the blood vessels that supply the heart muscle.

During the study, participants will be monitored for one year after receiving either AB-1002 or placebo. The research will track changes in heart function, exercise capacity, and overall well-being. AB-1002 is a type of gene therapy that uses a modified virus to deliver genetic material designed to help improve heart function in people with heart failure.

1 Initial assessment

Your heart function will be evaluated through a transthoracic echocardiography (heart ultrasound)

You will need to complete a six-minute walk test to assess your exercise capacity

Your heart failure symptoms will be classified according to the New York Heart Association (NYHA) Class III criteria

2 Treatment administration

You will receive a single dose of either AB-1002 or placebo through a coronary artery infusion

The medication will be administered by a heart specialist in a controlled medical setting

This procedure involves delivering the treatment directly to your heart through blood vessels

3 Follow-up period – 52 weeks

Your heart function will be monitored at weeks 4, 12, and 36 using heart ultrasound

Regular assessments will include heart function tests, walking tests, and quality of life questionnaires

Blood tests will be performed to measure heart-related substances

Your heart failure symptoms will be regularly evaluated

Any hospital visits related to heart failure will be recorded

4 Safety monitoring

Throughout the 52-week period, you will undergo regular health checks including:

Blood tests to monitor your general health

Vital signs measurements

Heart rhythm recordings (electrocardiograms)

Any health changes will be documented and assessed

5 Final evaluation

At the end of 52 weeks, a final assessment will include:

Heart ultrasound to measure heart function

Walking test to evaluate exercise capacity

Quality of life questionnaire completion

Final review of your heart failure symptoms

Who Can Join the Study?

  • Must be 18 years or older when signing the consent form
  • Have chronic non-ischemic cardiomyopathy (a heart muscle condition not caused by blocked arteries)
  • Have a left ventricular ejection fraction (a measure of heart pumping ability) between 15% and 35% as shown on heart ultrasound
  • Able to walk more than 50 meters during a 6-minute walking test
  • Have stable Class III heart failure (significant limitation in physical activity) for at least 4 weeks while on appropriate medications
  • Must be on stable doses of heart failure medications for at least 30 days, including:
    • Blood pressure medications
    • Beta blockers
    • Water pills
    • Diabetes medications (SGLT2 inhibitors)
  • If applicable, must have had a cardiac resynchronization device (special pacemaker) for at least 90 days or an implantable defibrillator for at least 30 days
  • Women who can become pregnant must use effective birth control methods, such as:
    • Intrauterine device in place for at least 90 days
    • Abstinence
    • Partner’s surgical sterilization for more than 180 days
    • Hormonal contraceptives for more than 90 days
  • Male participants must agree to contraception requirements:
    • Not donate sperm for 6 months after treatment
    • Use barrier methods if sexually active
    • Previous vasectomy (at least 180 days prior) is acceptable
  • Must be suitable for coronary artery procedure according to heart specialist
  • All sexually active participants must use barrier methods of protection for 6 months after treatment

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Presence of ischemic cardiomyopathy (heart muscle disease caused by coronary artery disease)
  • Heart failure symptoms classified as NYHA Class I, II or IV (NYHA III is required for participation)
  • Previous heart transplant or presence of a mechanical heart support device
  • Active infections or severe inflammatory conditions
  • Pregnant or breastfeeding women
  • Participation in other clinical trials within the past 30 days
  • Significant kidney or liver dysfunction
  • History of cancer within the past 5 years
  • Uncontrolled high blood pressure
  • Severe heart valve disease
  • History of blood clotting disorders
  • Allergic reactions to similar medications
  • Inability to provide informed consent
  • Conditions that might interfere with study procedures or follow-up visits

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Site Name City Country Status
Medizinische Hochschule Hannover Hanover Germany
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical University Of Graz Graz Austria
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Central Hospital Of Northern Pest Military Hospital Budapest Hungary
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
University Multiprofile Hospital For Active Treatment Sofiamed OOD Sofia Bulgaria
Noe LGA Gesundheit Region Mitte GmbH St. Poelten Austria
MHAT National Heart Hospital EAD Sofia Bulgaria
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Universitair Ziekenhuis Gent Gent Belgium
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland
Algemeen Ziekenhuis Delta Roeselare Belgium
Spitalul Clinic Judetean De Urgenta Craiova Craiova Romania
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Мultidisciplinary hospital for active treatment Saint George Pernik OOD Pernik Bulgaria
Specialized Hospital For Active Cardiology Treatement Cardiolife OOD Varna Bulgaria
Institutul De Boli Cardiovasculare Timisoara Timisoara Romania
Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar Hungary
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Gornoslaskie Centrum Mwdyczne Katowice Poland
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Semmelweis University Budapest Hungary
Stichting Radboud University Medical Center Nijmegen The Netherlands
Universidade De Santiago De Compostela Santiago De Compostela Spain
Spitalul Universitar De Urgenta Bucuresti Bucharest Romania
Kepler Universitaetsklinikum GmbH Linz Austria
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila Bucharest Romania
American Heart Of Poland S.A. Kedzierzyn-Kozle Poland
South West Hospital Ltd. Sandanski Bulgaria
University Of Pecs Pecs Hungary
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
University Of Szeged Szeged Hungary
Budapesti Uzsoki Utcai Korhaz Budapest Hungary
Uniklinikum Salzburg Salzburg Austria
Specialized Hospital For Active Cardiology Treatment Medica Kor EAD Ruse Bulgaria
Odpcjlrsgapoctsbbqkhluilpv Aalst Belgium
Sgwilgam Czgfnr Jabxnrdf Du Uprzfex Bnlzoz Brasov Romania
Awflfzczb Ugx Amsterdam The Netherlands
Ecwbmmu Uebtwmvdwgnn Mnxprak Cthkefi Rowarbovl (vsirneh Mce Rotterdam The Netherlands
Ukagqavapd Ow Abplyvt Edegem Belgium
Fcrfodeux Phie Ln Ifwubjxhumcex Bbyroxhpd Ddh Hcbxpjab Uqexcuugqvszw La Pha Madrid Spain
Kwtmqxegm Svaakft Spejrqnzackakgi ib Jirf Phklp Id Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
01.10.2024
Belgium Belgium
Not recruiting
01.10.2024
Bulgaria Bulgaria
Not recruiting
01.10.2024
Germany Germany
Not recruiting
01.10.2024
Hungary Hungary
Not recruiting
01.10.2024
Poland Poland
Not recruiting
01.10.2024
Romania Romania
Not recruiting
01.10.2024
Spain Spain
Not recruiting
01.10.2024
The Netherlands The Netherlands
Not recruiting
01.10.2024

Trial locations

Investigated drugs:

AB-1002 is an investigational therapy administered through intracoronary infusion (delivered directly into the heart’s blood vessels). This medication is being studied for treating patients with heart failure, specifically those with non-ischemic cardiomyopathy (a type of heart muscle disease not caused by blocked arteries). The therapy aims to help patients who have severe symptoms of heart failure classified as New York Heart Association (NYHA) Class III, where patients experience marked limitations in physical activity.

Non-ischemic Cardiomyopathy – A heart muscle disease not caused by coronary artery disease or heart attacks. In this condition, the heart muscle becomes enlarged, thick, or rigid, making it harder for the heart to pump blood effectively. The condition develops gradually and can affect people of any age. It often leads to heart chambers becoming dilated and weakened over time. The disease can be inherited or develop due to various factors including infections, certain medications, or other medical conditions.

Congestive Heart Failure – A chronic condition where the heart muscle cannot pump blood as well as it should. The condition causes blood and fluid to back up in the body, leading to congestion in the lungs, legs, and other tissues. This results in symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. The condition typically progresses gradually, affecting the body’s ability to meet its oxygen needs. The heart tries to compensate by enlarging and developing more muscle mass.

Trial ID:
2024-510581-17-00
Protocol code:
ASK-CHF2-CS201
NCT ID:
NCT05598333
Trial Phase:
Therapeutic exploratory (Phase II)

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