Short Term Hemodynamic Effects of Controlled Slow Breathing With Biofeedback in Patients With Heart Failure
Information source: Albert Einstein Healthcare Network
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Slow breathing (Behavioral)
Phase: N/A
Status: Completed
Sponsored by: Albert Einstein Healthcare Network Official(s) and/or principal investigator(s): Darshak H Karia, MD, Principal Investigator, Affiliation: Albert Einstein Healthcare Network
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.
Clinical Details
Official title: Short Term Hemodynamic Effects of Controlled Slow Breathing With Biofeedback in Patients With Heart Failure: Normal Healthy Subjects vs. Chronic Ambulatory Heart Failure Patients vs Acute Heart Failure
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
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 additional 550,000 patients being diagnosed with this syndrome each year for the
first time. Despite the significant advances in the management strategy of heart failure
patients in the last 1-2 decades, there are about 1 million hospital admissions each year
for Acute Decompensated Heart Failure (ADHF), almost double the number seen 15 years ago.
The readmission rate for these patients at 6-month following discharge approaches about 50%
with estimated 5-year mortality of 50%. Approximately, $23 billion are spent for the
inpatient management of HF patients with another $40 billion for outpatient care. This
prevailing situation mandates further exploration of novel therapeutic targets to treat this
complex disease.
Chronic HF is accompanied by a sustained elevation in sympathetic nervous system activity,
which is thought to be an important component in the pathophysiology and progression of the
disease. HF patients also show abnormal breathing pattern with an increased respiratory rate
and a lower tidal volume. Faster respiratory rate is associated with higher levels of
sympathetic activity and potentiation of the chemoreflex response to hypoxia and
hypercapnia. The relationship between sympathetic activity and spontaneous breathing rate is
independent of age, body mass index, physical activity levels, percentage of body fat, or
blood pressure. The arterial baroreflex sensitivity is also reduced in patients with heart
failure. All these factors contribute to the distressing symptoms of fatigue, dyspnea and
exercise intolerance in these patients.
Yoga trainees learn to breathe slowly, at a rate of about six breaths per minute, mobilizing
in sequence the diaphragm and the upper and the lower chest. A handful of studies in normal
subjects undergoing intensive training in yogic breathing techniques have demonstrated a
marked improvement in cardiac hemodynamic parameters (cardiac output, cardiac index, stroke
volume etc.), but such studies have not been conducted in patients with heart failure.
The purpose of our study is to evaluate the changes in cardiac hemodynamic parameters
(cardiac output, cardiac index and thoracic fluid content) in patients with acute heart
failure, chronic ambulatory heart failure and normal healthy subjects after a trial of
controlled slow breathing. Subjects would undergo non-invasive measurement of cardiac
hemodynamics while spontaneously breathing. They would then be given instructions in slow
breathing at a rate of 6 to 10 breaths per minute and asked to practice it for some time
using heart rate variability as biofeedback mechanism. Hemodynamic measurements would be
repeated during and after the trial of slow breathing. The difference between these
measurements would then be statistically analyzed. We hypothesize that even a short trial of
controlled slow breathing using a biofeedback mechanism in patients with HF would produce
significant favorable improvement in cardiac hemodynamics.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: NORMAL SUBJECTS
1. Normal subject without history, signs-symptoms or diagnosis of heart failure
2. Age over 18 and willing and able to provide informed consent.
Exclusion Criteria: NORMAL SUBJECTS
1. Known allergy to electrode gel and medical adhesive used on electrocardiographic
electrodes.
2. Pregnancy (as any effect of this device use on pregnancy is not known).
3. Patient belonging to a vulnerable population such as institutionalized persons,
prisoners and persons with decisional incapacity or dementia.
4. Presence of severe aortic regurgitation.
5. Second degree Mobitz type II or third degree heart block, unless treated with a
cardiac pacemaker.
6. 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.
7. Implantation of a cardiac resynchronization device within the last 30 days.
Inclusion Criteria: CHRONIC AMBULATORY HEART FAILURE
1. Patients over the age of 18 and able to give consent
2. Ability to understand and willing to sign informed consent
3. Diagnosis of Chronic Heart Failure and currently on optimal medical therapy
Exclusion Criteria: CHRONIC AMBULATORY HEART FAILURE
1. NYHA class III/ IV heart failure symptoms despite treatment with diuretics.
2. Co-existent pulmonary disease such as asthma/ COPD/ interstitial lung disease.
3. Known allergy to electrode gel and medical adhesive used on electrocardiographic
electrodes.
4. Pregnancy (as any effect of this device use on pregnancy is not known).
5. Patient belonging to a vulnerable population such as institutionalized persons,
prisoners and persons with decisional incapacity or dementia.
6. Presence of severe aortic regurgitation.
7. Second degree Mobitz type II or third degree heart block, unless treated with a
cardiac pacemaker.
8. 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.
9. Implantation of a cardiac resynchronization device within the last 30 days.
Inclusion Criteria: ACUTE HEART FAILURE
1. Patients over the age of 18 willing to and able to provide informed consent.
2. Patients admitted to the hospital with acute congestive heart failure (evidenced by
pulmonary edema by CXR, BNP> 500 pg/ml, jugular venous distension (JVD), crackles/
rales, dependent edema) who have been stabilized with medical therapy with evidence
of euvolemia by at least two of the following: clearance of rales/ crackles, decrease
in JVD, reduction in peripheral edema, decrease in BNP by at least 20%, no evidence
of pulmonary edema on CXR.
Exclusion Criteria: ACUTE HEART FAILURE
1. NYHA class III/ IV despite treatment with diuretics.
2. Co-existent pulmonary disease such as asthma/ COPD/ interstitial lung disease.
3. Known allergy to electrode gel and medical adhesive used on electrocardiographic
electrodes.
4. Pregnancy (as any effect of this device use on pregnancy is not known)..
5. Patient belonging to a vulnerable population such as institutionalized persons,
prisoners and persons with decisional incapacity or dementia.
6. Presence of severe aortic regurgitation.
7. Second degree Mobitz type II or third degree heart block, unless treated with a
cardiac pacemaker.
8. Implantation of a left ventricular assist 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.
9. Implantation of a cardiac resynchronization device within the last 30 days.
Locations and Contacts
Albert Einstein Healthcare Network, Philadelphia, Pennsylvania 19141, United States
Additional Information
Starting date: February 2008
Last updated: May 9, 2011
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