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

NCT00971386 | Completed

• 1 other identifier: HN 4025
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 that when slow breathing technique was taught to patients with heart failure, they had a reduction in their sensation of shortness of breath and an improvement in their exercise performance. The study will compare the short-term effects of controlled slow breathing with biofeedback in normal healthy subjects, acute heart failure, and chronic stable heart failure. The purpose is to see if there is any change in the objective measurements of heart function while breathing at normal rates compared to a controlled slower rate.

Conditions

Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Evaluate the changes in cardiac hemodynamic parameters (Cardiac output, cardiac index, and thoracic fluid content) between normal, acute HF and chronic HF subjects with a trial of controlled slow breathing with biofeedback.

  Half hour

Study Arms (3)

Normal Healthy Subjects

OTHER

Normal healthy subjects without history, signs-symptoms or diagnosis of heart failure

Behavioral: Slow breathing

Chronic Ambulatory Heart Failure

OTHER

Diagnosis of Chronic Heart Failure and currently on optimal medical therapy

Behavioral: Slow breathing

Acute Heart Failure

OTHER

Patients admitted to the hospital with acute congestive heart failure.

Behavioral: Slow breathing

Interventions

Slow breathing BEHAVIORAL

The subjects will be given instructions in slow breathing at a rate of 6 to 10 breaths per minute and asked to practice it for some time. Hemodynamic measurements would be repeated before, during and after the trial of slow breathing. A Noninvasive Cardiac Output Monitor will be used. It uses a technology called impedance to measure cardiac output and other hemodynamic parameters by the passage of electric currents through the thorax. This device uses four electrode stickers applied to the thorax and the neck.

Acute Heart Failure; Chronic Ambulatory Heart Failure; Normal Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• 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
• NYHA class III/ IV heart failure symptoms despite treatment with diuretics.
• Co-existent pulmonary disease such as asthma/ COPD/ interstitial lung disease.
• 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.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Darshak H Karia, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: September 3, 2009
• Study Start: February 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 10, 2011

Record last verified: 2011-05

Locations

US (1)