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Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design.

ABSTRACT: AIMS:Cardiopoiesis is a conditioning programme that aims to upgrade the cardioregenerative aptitude of patient-derived stem cells through lineage specification. Cardiopoietic stem cells tested initially for feasibility and safety exhibited signs of clinical benefit in patients with ischaemic heart failure (HF) warranting definitive evaluation. Accordingly, CHART-1 is designed as a large randomized, sham-controlled multicentre study aimed to validate cardiopoietic stem cell therapy. METHODS:Patients (n = 240) with chronic HF secondary to ischaemic heart disease, reduced LVEF (<35%), and at high risk for recurrent HF-related events, despite optimal medical therapy, will be randomized 1:1 to receive 600?×?10(6) bone marrow-derived and lineage-directed autologous cardiopoietic stem cells administered via a retention-enhanced intramyocardial injection catheter or a sham procedure. The primary efficacy endpoint is a hierarchical composite of mortality, worsening HF, Minnesota Living with Heart Failure Questionnaire score, 6 min walk test, LV end-systolic volume, and LVEF at 9 months. The secondary efficacy endpoint is the time to cardiovascular death or worsening HF at 12 months. Safety endpoints include mortality, readmissions, aborted sudden deaths, and serious adverse events at 12 and 24 months. CONCLUSION:The CHART-1 clinical trial is powered to examine the therapeutic impact of lineage-directed stem cells as a strategy to achieve cardiac regeneration in HF populations. On completion, CHART-1 will offer a definitive evaluation of the efficacy and safety of cardiopoietic stem cells in the treatment of chronic ischaemic HF. TRIAL REGISTRATION:NCT01768702.

SUBMITTER: Bartunek J

PROVIDER: S-EPMC5064644 | biostudies-literature | 2016 Feb

REPOSITORIES: biostudies-literature

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Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design.

Bartunek Jozef J Davison Beth B Sherman Warren W Povsic Thomas T Henry Timothy D TD Gersh Bernard B Metra Marco M Filippatos Gerasimos G Hajjar Roger R Behfar Atta A Homsy Christian C Cotter Gad G Wijns William W Tendera Michal M Terzic Andre A

European journal of heart failure 20151214 2

<h4>Aims</h4>Cardiopoiesis is a conditioning programme that aims to upgrade the cardioregenerative aptitude of patient-derived stem cells through lineage specification. Cardiopoietic stem cells tested initially for feasibility and safety exhibited signs of clinical benefit in patients with ischaemic heart failure (HF) warranting definitive evaluation. Accordingly, CHART-1 is designed as a large randomized, sham-controlled multicentre study aimed to validate cardiopoietic stem cell therapy.<h4>Me ...[more]

PMID: 26662998

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Project description:ObjectiveHeart failure (HF) continues to be a leading cause of hospital admissions, particularly in underserved patients. We hypothesised that providing individualised self-management support to patients and feedback on use of evidence-based HF therapies (EBT) to physicians could lead to improvements in care and decrease hospitalisations. To assess the feasibility of conducting a larger trial testing the efficacy of this dual-level intervention, we conducted the Congestive Heart failure Adherence Redesign Trial Pilot (CHART-P), a proof-of-concept, quasi-experimental, feasibility pilot study.SettingA large tertiary care medical centre in Chicago.ParticipantsLow-income patients (<US$30,000/year) hospitalised for exacerbation of systolic HF (ejection fraction ≤50%) and their physicians. Twenty physicians and 33 patients were enrolled, of whom 23 patients completed the study.InterventionsPhysicians received HF guidelines and periodic individualised feedback on their adherence to EBT. Patients received HF education, support and self-management training for diet and medication adherence by a trained nurse through 11 interactive sessions over a 4-month period. Evaluations were conducted pre-enrolment and 1 month postintervention completion.Outcome measuresFeasibility was assessed by the ability to deliver intervention to patients and physicians. Exploratory outcomes included changes in medication and sodium intake for patients and adherence to EBT for physicians.ResultsEighty-seven per cent and 82% of patients received >80% of interventions at 1 month and by study completion, respectively. Median sodium intake declined (3.5 vs 2.0 g; p<0.01). There was no statistically significant change in medication adherence based on electronic pill cap monitoring or the Morisky Medication Adherence Scale (MMAS); however, there was a trend towards improved adherence based on MMAS. All physicians received timely intervention.ConclusionsThis pilot study demonstrated that the protocol was feasible. It provided important insights about the need for intervention and the difficulties in treating patients with a variety of psychosocial problems that undercut their effective care.

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Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design.

Publications

Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial design.

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