Direct Endomyocardial Injection of Autologous Bone Marrow Cells to Treat Ischaemic Heart Failure

NCT01150175 | Unknown Phase 2

• 2 other identifiers: HKCTR-763END-HF Version 1:17-5-08
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether direct endomyocardial injection of autologous bone marrow cells is effective for enhancement of neovascularisation in patients with ischaemic heart failure.

Conditions

Coronary Artery Disease

Keywords

END-HF

Outcome Measures

Primary Outcomes (1)

• MRI ejection fraction

  MRI ejection fraction changed from baseline to 6 months

Secondary Outcomes (1)

• Changes in exercise duration and MVO2 using standardized treadmill testing(modified Bruce protocol) from baseline to 6 months

  Baseline to 6 months

Study Arms (2)

Autologous bone marrow cells

EXPERIMENTAL

Procedure: Endomyocardial Injection of Autologous Bone Marrow Cells

Plasma

PLACEBO COMPARATOR

Procedure: Endomyocardial Injection of Plasma

Interventions

Endomyocardial Injection of Autologous Bone Marrow Cells PROCEDURE

Endomyocardial Injection of Autologous Bone Marrow Cells

Also known as: END-HF

Autologous bone marrow cells

Endomyocardial Injection of Plasma PROCEDURE

Endomyocardial Injection of Plasma

Also known as: END-HF

Plasma

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old
• Canadian cardiovascular (CV) Class II-IV angina and/or NYHA class II-III HF symptoms
• Received stable and "best" cardiac medical therapy including long-acting nitrates, beta-blocker, and angiotensin-converting enzyme inhibitors without control of symptoms.
• Not suitable for conventional revascularization by their referring cardiologist.
• LVEF \<40% by echocardiography.
• Recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of CAD that is not amenable to standard revascularization procedures.
• creatinine less than 250mmol/L, normal liver function, and normal blood count: WBC, granulocytes; platelet count, Hb.
• Reversible perfusion defect on single photon emission computed tomography (SPECT)
• Able to walk on treadmill
• Hemodynamically stable
• Subject is willing to comply with specified follow-up evaluations.
• All patients give written informed consent.

You may not qualify if:

• Atrial fibrillation
• History of syncope or major ventricular arrhythmias such as sustained ventricular tachycardia or ventricular fibrillation
• Severe valve disease
• Aortic or mitral valve prosthesis
• History of cancer in last 5 years
• Acute or chronic active sepsis, including HIV positive; hepatitis B or C positive
• Left ventricular wall thickness less than 8 mm in the target territory
• Left ventricular thrombus and/or spontaneous echo-contrast in the LV detected by echocardiography or LV aneurysm
• Severe aorto-femoral-iliac disease
• Recent heart attack within the last 30 days
• Hypertrophic or restrictive cardiomyopathy
• Severe co-morbidity associated with a reduction in life expectancy of less than 1 year

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Prof. HF Tse

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 24, 2010
• First Posted: June 24, 2010
• Study Start: July 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 24, 2010

Record last verified: 2010-06

Locations

CN (1)