Heart FailureNCT00971386
Short Term Hemodynamic Effects of Controlled Slow Breathing With Biofeedback in Patients With Heart Failure
A study testing Slow breathing in people with Heart Failure, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Slow breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal subject without history, signs-symptoms or diagnosis of heart failure
- Age over 18 and willing and able to provide informed consent.
- 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
- Patients over the age of 18 willing to and able to provide informed consent.
- 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.
Who cannot join
- 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.
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- Implantation of a cardiac resynchronization device within the last 30 days.
- 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.
- 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.
- NYHA class III/ IV 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.
- 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 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.
- Implantation of a cardiac resynchronization device within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
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
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Slow breathing
- Keywords
- Heart Failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow breathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Normal Healthy Subjects | Other | Normal healthy subjects without history, signs-symptoms or diagnosis of heart failure Receives: Behavioral: Slow breathing |
| Chronic Ambulatory Heart Failure | Other | Diagnosis of Chronic Heart Failure and currently on optimal medical therapy Receives: Behavioral: Slow breathing |
| Acute Heart Failure | Other | Patients admitted to the hospital with acute congestive heart failure. Receives: Behavioral: Slow breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Half hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startFeb 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Investigators
- Darshak H Karia, MD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971386
- Sponsor's protocol ID
- HN 4025
- Status last verified
- May 2011
- First submitted
- 5 Aug 2009
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00971386
- Acronym / sponsor ID
- HN 4025
- Conditions
- Heart Failure
- Keywords
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 3 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Subjects | Other | Behavioral: Slow breathingNormal healthy subjects without history, signs-symptoms or diagnosis of heart failure |
| Chronic Ambulatory Heart Failure | Other | Behavioral: Slow breathingDiagnosis of Chronic Heart Failure and currently on optimal medical therapy |
| Acute Heart Failure | Other | Behavioral: Slow breathingPatients admitted to the hospital with acute congestive heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Normal subject without history, signs-symptoms or diagnosis of heart failure
- Age over 18 and willing and able to provide informed consent.
- 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 exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow breathingThe 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. | Behavioural | Acute Heart Failure, Chronic Ambulatory Heart Failure, Normal Healthy Subjects |
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.
Time frame: Half hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darshak H Karia, MD principal investigator
Albert Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow breathing in people with Heart Failure, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Half hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2011.