Status:

COMPLETED

Short Term Hemodynamic Effects of Controlled Slow Breathing With Biofeedback in Patients With Heart Failure

Lead Sponsor:

Albert Einstein Healthcare Network

Conditions:

Heart Failure

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Heart failure is associated with faster breathing, which has a negative impact on the functioning of the heart. This leads to fatigue, shortness of breath, and exercise intolerance. It has been shown ...

Detailed Description

Heart Failure (HF) is a growing and challenging public health concern in the United States. Current data suggest that there are about 5 million heart failure patients in this country with an additiona...

Eligibility Criteria

Inclusion

  • NORMAL SUBJECTS
  • Normal subject without history, signs-symptoms or diagnosis of heart failure
  • Age over 18 and willing and able to provide informed consent.

Exclusion

  • NORMAL SUBJECTS
  • Known allergy to electrode gel and medical adhesive used on electrocardiographic electrodes.
  • Pregnancy (as any effect of this device use on pregnancy is not known).
  • Patient belonging to a vulnerable population such as institutionalized persons, prisoners and persons with decisional incapacity or dementia.
  • Presence of severe aortic regurgitation.
  • Second degree Mobitz type II or third degree heart block, unless treated with a cardiac pacemaker.
  • Implantation of a left ventricular assists device, hemodynamic monitor, activated minute ventilation pacemaker, or biventricular pacemaker (Cardiac Resynchronization Therapy) with the V-to-V interval set at more than 5 milliseconds offset.
  • Implantation of a cardiac resynchronization device within the last 30 days.
  • Inclusion Criteria: CHRONIC AMBULATORY HEART FAILURE
  • Patients over the age of 18 and able to give consent
  • Ability to understand and willing to sign informed consent
  • Diagnosis of Chronic Heart Failure and currently on optimal medical therapy

Key Trial Info

Start Date :

February 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT00971386

Start Date

February 1 2008

End Date

October 1 2009

Last Update

May 10 2011

Active Locations (1)

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1

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States, 19141

Short Term Hemodynamic Effects of Controlled Slow Breathing With Biofeedback in Patients With Heart Failure | DecenTrialz