Myocardial regeneration using shockwave, DPP4 inhibitor and PTH. V1
Research type
Research Study
Full title
Phase 1 of dose escalation of extracorporeal shockwave treatment only and in combination DPP-4 inhibitor and parathyroid hormone (non-randomised, open-labelled) & Phase II of combination treatments of shockwave, a DPP-4 inhibitor and parathyroid hormone (randomised-controlled, open-labelled) in the ischemic cardiomyopathy population.
IRAS ID
117460
Contact name
Petros Nihoyannopoulos
Contact email
Sponsor organisation
Imperial College London
Eudract number
2013-004333-33
Research summary
When the heart is damaged from a heart attack, heart failure may then ensue, a condition when the heart is not able to function as a pump. The condition is considered irreversible and carries a poor outlook for the patient. In this research we want to test whether the combination treatments of shockwave, dipeptidyl peptidase-4 inhibitor and parathyroid hormone are able to repair the damaged heart. Shockwave is a type of sound energy, delivered non-invasively. The treatment induces a chemical response that gives the heart the ability to attract stem cells to it to start the repair process, and make new blood vessels to improve its blood supply. The administration of dipeptidyl peptidase-4 inhibitor will intensify the chemical response and hence increase the attraction of stem cells to the heart whilst parathyroid hormone will release more stem cell in the circulation. We will be the first to conduct a stem cell trial such as this, where participants‘ own stem cells are constantly mobilised in the blood and delivered to where it should be over a period of time, to give the heart the opportunity to repair itself. We plan to assess for the positive effects of treatments, if any, by taking serial measurements of the heart using sophisticated cardiac scanners to assess its function, assess participant’s ability to exercise and the overall impact on the quality of life. We look to recruit men or women who have heart failure as a result of heart attacks. The patients will either receive shockwave treatments with and without the two drugs over 32 weeks. They are then compared with a group of patients who receive the best current medical treatment. The trial will be conducted at a joint university and hospital facility, and it is anticipated to complete within two years.
REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/1646
Date of REC Opinion
20 Jan 2014
REC opinion
Further Information Favourable Opinion