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Stem Cells Therapy in Advanced Heart Failure

Primary Purpose

Congestive Heart Failure

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
stem cells infusion
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Congestive Heart Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Celestino SarduRecruiting
  • Raffaele MarfellaRecruiting
  • Celestino SarduRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stem cells infusion

Arm Description

Outcomes

Primary Outcome Measures

NYHA class improvement
reduction in hospitalization rate
reduction in angor symptoms

Secondary Outcome Measures

Full Information

First Posted
August 10, 2016
Last Updated
August 11, 2020
Sponsor
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT02871466
Brief Title
Stem Cells Therapy in Advanced Heart Failure
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 Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stem cells infusion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
stem cells infusion
Primary Outcome Measure Information:
Title
NYHA class improvement
Time Frame
12 months
Title
reduction in hospitalization rate
Time Frame
12 months
Title
reduction in angor symptoms
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raffaele Marfella, MD, PhD
Phone
00390815566101
Email
raffaele.marfella@unicampania.it
Facility Information:
Facility Name
Celestino Sardu
City
Naples
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Marfella
Facility Name
Raffaele Marfella
City
Naples
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Marfella, MD, PhD
Phone
+39 0810815665110
Email
raffaele.marfella@unicampania.it
First Name & Middle Initial & Last Name & Degree
Celestino Sardu, MD, MSc, PhD
Phone
+393336664543
Email
drsarducele@gmail.com
Facility Name
Celestino Sardu
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Marfella

12. IPD Sharing Statement

Plan to Share IPD
No

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Stem Cells Therapy in Advanced Heart Failure

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