In the preparation phase of this randomized, open-label phase IIa trial, SCIRENT performed a review of the study protocol, prepared and adjusted the trial management documents, and advised the sponsor how to set up the eCRF system. Moreover, SCIRENT has helped in the setup and management of a Scientific Steering Committee consisting of high-ranking scientists on behalf of the sponsor.
Due to the extensive scientific experience of SCIRENT’s management team and the advice given, the trial’s scientific standard improved significantly. The review of the study protocol resulted in various protocol adaptations that positively influenced the trial’s overall performance. The Steering Committee for this trial comprises some of the highest-ranking international opinion leaders in the field of heart failure research who act as advisors for this trial.
In a First in Human pilot study, ten patients with pronounced non-ischemic dilated cardiomyopathy were treated with a novel implantable electroceutical device. The medical device was designed by Berlin Heals Holding AG to treat heart failure by using electrical microcurrent to induce a progression from reverse modeling to myocardial recovery.
After the trial initially had recruitment difficulties in another country managed by another CRO, SCIRENT proposed to work with selected sites that are particularly well-suited for this early phase pilot trial due to their specialization and experience. SCIRENT managed the patient recruitment activities for these sites, prepared regulatory submissions, revised TMF documents, and performed the monitoring activities.
The first results of this trial indicate the safety and overwhelming effects of this application. Due to the highly-qualified SCIRENT staff and the engaged investigators at the sites, the implantation of the novel device worked without problems. The sites hit the enrollment target within four months. The sponsor now plans a CE-mark trial in cooperation with SCIRENT.
Stealth Biotherapeutics is a leading biopharmaceutical company in mitochondrial medicine. The company conducted a trial to evaluate whether patients with heart failure can benefit from mitochondrial therapies. For the patient population with preserved ejection fraction, the trial objective was to demonstrate an improvement in cardiac function.
SCIRENT supported Stealth Biotherapeutics in the development and refinement of the study protocol, particularly in the definition of the endpoint which utilized exercise echocardiogram following expert advice and discussions with the steering committee. SCIRENT developed the echocardiography manual together with leading experts in this field, and helped set up the steering committee and the echo core lab. Furthermore, SCIRENT established an infrastructure that enabled an eligibility assessment through the echo core lab before randomization. SCIRENT also identified sites that could perform these complex measurements and organized the necessary staff training.
The trial achieved all milestones within the scheduled timelines. The echocardiography examination delivered high-quality data, and there was a smooth communication between sites and the echo core lab.
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