Idiopathic Dilated Cardiomyopathy Clinical Trial
Official title:
Multicenter Phase IIb Clinical Trial, Double-blind, Randomized, Controlled Placebo for to Assess the Efficacy of Intracoronary Infusion of Autologous Adult Stem Cells Mononuclear Marrow Unexpanded on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.
Clinical trial phase IIb, double-blind, randomized, controlled with placebo. There is sufficient preliminary evidence to consider intracoronary injection of bone marrow progenitor cells as a viable, safe and beneficial treatment in patients with dilated cardiomyopathy, although the biological mechanism of action of bone marrow cells in the myocardium is not known. In this project we propose to investigate comparatively and from a biological and clinical point of view the applicability of regenerative therapy with autologous bone marrow cells in patients with dilated cardiomyopathy.
The study population correspond to male and female patients with idiopathic dilated
cardiomyopathy.
51 patients diagnosed with this disease are included. After inclusion, will proceed to the
random allocation to study group or control group in a 2:1 ratio, 34 patients in the
treatment group and 17 in the control group.
The total duration is expected to be 48 months: The inclusion period is 24 months and each
patient assigned to the experimental group will be followed for 24 months, whereas that one
ramdomized to the control group, will have a folow-up of 12 months. Upon completion there of,
the patients will be followed in routine clinical practice.
This is a double blind study, in which all patients will perform the bone marrow harvesting.
All patients will receive the best medical treatment individualized (ACEIs or Angiotensin II
receptor blocker, beta-blockers, diuretics and eplerenone) for at least 6 months prior to
their participation in the clinical trial, so that the situation is stable and
pharmacological basal condition is the same for everyone.
The bone marrow cells of patients assigned to placebo group will be cryopreserved, and once
the trial is completed, the blind will be opened and all the patients who had been randomized
to the control group, may be processed by the route of compassionate use with their own
mononuclear bone marrow cells previously frozen.
The patients who are randomized to experimental group will be treated by the conventional
treatment + infusion of autologous mononuclear bone marrow cells not expanded whereas the
patients who are randomized to control group will be treated by the conventional treatment +
infusion of placebo.
The main objective is to assess comparative the efficacy of intracoronary injection of bone
marrow stem cells autologous to improve ventricular function in patients with idiopathic
dilated cardiomyopathy who receive conventional medical treatment, compared with a control
group who receive a infusion of placebo and conventional medical treatment. The improvement
in ventricular function assessed by changes in angiographically determined ejection fraction.
Secondary objectives of the study are:
- To analyze the predictors of good clinical response, functional and biological treatment
with adult stem cells autologous mononuclear bone marrow not expanded in terms of functional
recovery.
The following parameters were evaluated: Functional class (NYHA), Natriuretic peptide B,
Stress test (exercise time), Echocardiographic parameters of ventricular function, for
example LVEF (%), TDV (ml), TSV (ml) and TAPSE (ms) and Biological parameters of cellular
functionality, for example CD133 +, CD34 +, CD34 +/CD177 + and CD34 +/CD38- (in %).
- To determine, in the light of the obtained results, the application protocol suitable cell
therapy for the treatment of dilated cardiomyopathy.
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