Using engineered heart muscle to treat advanced heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The BioVAT-HF trial aims to evaluate the safety and efficacy of engineered heart muscle (EHM) derived from induced pluripotent stem cells for patients with advanced heart failure and reduced ejection fraction. This innovative approach involves implanting EHM into the failing heart to promote remuscularization and enhance myocardial performance. The study targets patients who are not candidates for heart transplantation and have specific heart function criteria. Comprehensive preclinical testing has laid the groundwork for this clinical application.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Symptomatic heart failure (NYHA II-IV) with reduced ejection fraction (HFrEF with LVEF ≤35%) as assessed by echocardiography.
2. Patients on guideline-directed medical therapy
3. NT-proBNP \>300 pg/mL for patients in sinus rhythm or \>900 pg/mL if in atrial fibrillation
4. History of previous heart failure hospitalization in the past 12 months
5. At least one hypo- or dyskinetic segment or dilated heart chamber to demark the implant target area
6. (A) Stable disease condition allowing for an elective left-lateral mini-thoracotomy (for LV applications) or (B) open-chest surgery (for RV applications) for a clinically indicated intervention on the LV (e.g., coronary bypass surgery, valve repair, mechanical circulatory support device implantation) with concomitant RV dysfunction, diagnosed using the Tricuspid Annular Plane Systolic Excursion (TAPSE) index \<16 mm (Rudski et al. 2010).
7. 18-80 years of age
8. Willingness and ability to give written informed consent
9. Female subjects of childbearing potential must agree to use acceptable method(s) of contraception for the full study duration.

Exclusion Criteria:

1. Contraindication to immunosuppressive drugs (e.g. known history of unresolved cancer, hepatitis B/C, HIV, HTLV1)
2. Contraindication to TachoSil® (e.g. hypersensitivity to human fibrinogen, human thrombin, horse collagen, human albumin, Riboflavin, Natriumchloride, Natriumcitrate, L-Arginin-Hydrochloride)
3. Hypertrophic cardiomyopathy (HCM)
4. Terminal kidney failure (stage 4; GFR \<30 ml/min) at the time of enrolment
5. Terminal liver failure (Child-Pugh stage C; score \>10) at the time of enrolment
6. History of disabling stroke
7. Reduced life expectancy in the short term due to non-cardiac disease
8. Any condition that excludes adherence to study protocol (in particular lack of adherence to prescribed medication)
9. Simultaneous participation in another interventional trial
10. Pregnant or breastfeeding females
11. Known or suspected alcohol and/or drug abuse

Where it's running

• University Medical Center Göttingen
  Göttingen, Lower Saxony, Germany Recruiting
• University Medical Center Schleswig-Holstein
  Lübeck, Schleswig-Holstein, Germany Recruiting
• Herz- und Diabeteszentrum Nordrhein-Westfalen
  Bad Oeynhausen, North Rhine-Westphalia, Germany Not yet recruiting

Study contacts

• Principal investigator: Tim Seidler, Prof. — University Medical Center Goettingen
• Study coordinator: Wolfram-Hubertus Zimmermann, Prof.
• Email: sekretariat.pharma@med.uni-goettingen.de
• Phone: +49 551 / 3965781

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

  Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07912086

• Tailored digital support to cut sedentary time in long-term cardiac rehab

  In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.

  Recruiting University of Lisbon · Lisbon, Lisbon District · NCT07910812

• NT-proBNP–guided heart failure screening for people 65+ in rural China

  This study tests whether using NT-proBNP blood tests to guide heart failure screening in adults 65 and older in rural China can find unrecognized heart problems more effectively than symptom-based screening.

  Recruiting Jiangsu Taizhou People's Hospital · Nanjing · NCT07885488

• Voice-based detection of heart failure deterioration using Noah Labs Vox

  This study tests whether a voice-analysis app can flag worsening heart failure in adults by comparing its alerts to standard weight-based monitoring.

  Recruiting Noah Labs · Boston, Massachusetts · NCT07870395

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.