NCT03039751CompletedPhase 2
Adenovirus Vascular Endothelial Growth Factor D (AdvVEGF-D) Therapy for Treatment of Refractory Angina Pectoris
Clinical Development and Proof of Principle Testing of New Regenerative Adenovirus Vascular Endothelial Growth Factor (VEGF-D) Therapy for Cost-effective Treatment of Refractory Angina. A Phase II Randomized, Double-blinded, Placebo-controlled Study (ReGenHeart)
Source: ClinicalTrials.gov · Last updated 13 Jan 2025
Brief summary (registry, in English)
The purpose of the study is to evaluate the safety and efficacy of catheter mediated endocardial adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D) regenerative gene transfer in patients with refractory angina to whom revascularisation cannot be performed.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 3 Jan 2017
- Start date
- 19 Oct 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Kuopio University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT03039751
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 63
- From 19 Oct 2019 to the primary completion date, 31 Dec 2023
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- immunosuppressive medication
Other illness
- diabetes mellitus with severe complications such as diabetic retinopathy or nephropathy
- severe hypertension (systolic blood pressure \> 200 mmHg or diastolic blood pressure \> 110 mmHg) or significant hypotension (systolic blood pressure \< 90 mmHg)
- acute infection
- symptomatic congestive heart failure (New York Heart Association class 3-4)
- haemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery
- recent (\< 6 weeks) acute coronary syndrome or myocardial infarction, PCI or CABG, stroke or transient ischemic attack (TIA)
- current or suspected malignancy
Lab values
- clinically significant anemia (hemoglobin count \< 120 mg/l in male, \< 110 mg/l in female; hematocrit \< 0.36), leukopenia (b-leukocyte count \< 3.0x109/l), leukocytosis (b-leukocyte count \> 12.0x109/l) or thrombocytopenia (b-thrombocyte count \< 100x109/l)
- renal insufficiency (P-creatinine \> 160 mg/l)
- liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal)
- significant impairment of left ventricular function (ejection fraction \< 25% in echocardiography)
Age
- women in fertile age
Other
- haematuria of unknown origin
- significant obesity (Body Mass Index \> 35)
Who the study is looking for
- informed consent signed
- age \> 30 but \< 85 years
- significant angina pectoris (CCS 2-3) despite of optimal medication
- significant stenosis (\> 60%) in coronary angiography (\< 6 months)
- contraindication to CABG or PCI due to diffuse or distal stenosis, chronic total occlusion, vessels with difficult anatomy, stenosis with severe calcifications and stenosis in small vessels (\<2.5 mm))
- angina pectoris or equivalent symptoms in the 6-minute walking exercise test
- left ventricle wall \> 8 mm detected by transthoracic echocardiography or magnetic resonance imaging (treatment area)
Age in the registry: 30 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Kuopio University Hospital Coordinator of this site? Confirm its status | Kuopio | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.