Status:

COMPLETED

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

Lead Sponsor:

University of Aarhus

Collaborating Sponsors:

Aarhus University Hospital Skejby

Central Jutland Regional Hospital

Conditions:

Chronic Systolic Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

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 i...

Detailed Description

Background Chronic heart failure (CHF) is a leading cause of morbidity and mortality throughout the world, and the incidence and prevalence are increasing as more patients survive their acute coronary...

Eligibility Criteria

Inclusion

  • Group 1 (Chronic heart failure patients):
  • \>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

Exclusion

  • 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):
  • Inclusion criteria:
  • \>18 years of age
  • Able to understand the written patient information and to give informed consent
  • Left ventricular ejection fraction \>45%
  • Exclusion criteria:
  • 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
  • Intake of caffeine within 24 hours of either study visit
  • Intake of alcohol within 24 hours of either study visit
  • Patients with ischemic heart disease
  • Patients with diabetes mellitus
  • Patients with peripheral neuropathy
  • Patients in dialysis treatment
  • Patients in treatment with Vitamin K-antagonists, adenosine diphosphate-receptor-inhibitor, oral anticoagulants or dipyridamol.
  • Conditions contraindicating short term cessation of acetylsalicylic acid and/or non-steroidal anti-inflammatory drug intake
  • Contraindication for Magnetic Resonance Imaging examination (e.g. metal implants) precluding Magnetic Resonance Imaging
  • Other concomitant disease or treatment that according to the investigator's assessment makes the patient unsuitable for study participation.

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2016

Estimated Enrollment :

47 Patients enrolled

Trial Details

Trial ID

NCT02248441

Start Date

September 1 2014

End Date

February 1 2016

Last Update

August 24 2017

Active Locations (1)

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Aarhus University Hospital Skejby

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