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Stem Cells Therapy in Advanced Heart Failure

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ClinicalTrials.gov Identifier: NCT02871466
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
Celestino Sardu, University of Campania "Luigi Vanvitelli"

Brief Summary:
stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, internal cardiovertor with a defibrillator (ICD) recipients, and a previous history of myocardial infarction and coronary artery revascularization. These patients, without indication to receive a cardiac resynchronization therapy (CRT), may have a worsening of heart failure, and symptoms of coronary artery disease. In this study we have evaluated in consecutive 30 selected patients the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, and associated to reduction of angina after a treatment with stem cells intra thoracic infusion.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: stem cells infusion Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra Cardiac Autologous Stem Cells Infusion May Improve Clinical Outcomes in Failing Heart Subjects Refractory to Maximal Drug Therapy and Internal Cardioverter With a Defibrillator (ICD) Recipients
Study Start Date : January 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: stem cells infusion Drug: stem cells infusion



Primary Outcome Measures :
  1. NYHA class improvement [ Time Frame: 12 months ]
  2. reduction in hospitalization rate [ Time Frame: 12 months ]
  3. reduction in angor symptoms [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • heart failure post coronary artery disease, refractory to maximal medical therapy, previous coronary artery surgical revascularization.

Exclusion Criteria:

  • inflammatory chronic diseases, neoplastic diseases.

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Responsible Party: Celestino Sardu, principal investigator, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT02871466     History of Changes
Other Study ID Numbers: 8.2016
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases