Effect of Remote Ischemic Conditioning in Patients With Chronic Ischemic Heart Failure

NCT02248441 | Completed

• 1 other identifier: VEK: 1-10-72-173-14
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The present study will evaluate whether treatment with daily remote ischemic conditioning for a 28±4-day period induces beneficial effects in subjects with and without chronic ischemic heart failure in terms of improved left ventricular contractile function and exercise capacity.

Conditions

Chronic Systolic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction assessed by MRI

  28±4 days

Secondary Outcomes (6)

• Global and regional myocardial function by strain analysis assessed by MRI

  28±4 days

• Left ventricular mass and end-diastolic volume assessed by MRI

  28±4 days

• Cardiac output assessed by MRI

  28±4 days

• Cardiopulmonary exercise capacity assessed by staged exercise bicycle test and leg extension power rig test

  28±4 days

• Serology markers for heart failure

  28±4 days

Study Arms (1)

Daily RIC

EXPERIMENTAL

Daily ischemic conditioning treatment

Other: Daily ischemic conditioning treatment

Interventions

Daily ischemic conditioning treatment OTHER

RIC stimulus will be conducted as 4 x 5 minutes upper arm ischemia achieved by inflation of a blood pressure cuff to 200 mmHg and 5 minutes reperfusion between inflations. The procedure will be performed using the AutoRICTM (CellAegis Devices Inc., Toronto, Ontario, Canada).

Daily RIC

Eligibility Criteria

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

You may qualify if:

• \>18 years of age
• Able to understand the written patient information and to give informed consent
• Chronic congestive ischemic heart failure
• Left ventricular ejection fraction ≤45%
• New York Heart Association functional class I-III

You may not qualify if:

• Recent cardiovascular hospitalization (within last 30 days) • Strenuous exercise within 72 hours of either study visits
• Intake of caffeine within 24 hours of either study visit
• Intake of alcohol within 24 hours of either study visit
• Patients with permanent atrial fibrillation • Patients with diabetes mellitus
• Patients with peripheral neuropathy
• Patients in dialysis treatment
• Contraindication for Magnetic Resonance Imaging examination (e.g. metal implants including Cardiac Resynchronisation Therapy devices and other pacemakers or defibrillators) precluding Magnetic Resonance Imaging
• Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation.
• Group 2 (Volunteers without ischemic heart disease):
• \>18 years of age
• Able to understand the written patient information and to give informed consent
• Left ventricular ejection fraction \>45%
• Recent cardiovascular hospitalization (within last 30 days)
• Intake of acetylsalicylic acid or non-steroidal anti-inflammatory drug medication within 7 days of either study visit
• Strenuous exercise within 72 hours of either study visit

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital Skejby: collaborator
• Central Jutland Regional Hospital: collaborator

Study Sites (1)

Aarhus University Hospital Skejby

Aarhus N, Dk-8200 Aarhus N, 8200, Denmark

Location

Study Officials

• Hans Erik Bøtker, Prof.

  Department of Cardiology, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 24, 2017

Record last verified: 2016-10

Locations

DK (1)