Congestive Heart FailureNCT03449121
Study for Breathing Interventions in Congestive Heart Failure
A study testing Slow breathing techniques in people with Congestive Heart Failure, run by Vanderbilt University Medical Center.
Trial summary
Slow breathing may reduce stress. Adults with congestive heart failure have higher stress than the general population. This study will examine if using slow breathing is feasible among adults with heart failure. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Slow breathing techniques
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to May 2019
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented heart failure from medical chart review with signs and symptoms consistent with disease
- Reduced left ventricular function with ejection fraction of less than or equal to 40%
- English speaking
Who cannot join
- New York Heart Failure Association Class I or IV
- Myocardial infarction in the last 3 months
- Cardiac surgery in the last 3 months
- Significant valvular heart disease
- Uncontrolled cardiac arrhythmias
- Uncontrolled diabetes mellitus (hemoglobin a1c ≥ 8)
Show all 19Show fewer
- Uncontrolled hypertension
- Systolic greater than 140 mmHg
- Diastolic greater than or 90 mmHg
- Cognitive impairment (Mini-mental state exam less than or equal to 24)
- Acute major depression in the last 3 months
- Other psychiatric conditions including schizophrenia or bipolar disorder
- Attention-deficit-disorder or attention-deficit-hyperactivity disorder
- Musculoskeletal condition limiting capacity to perform simple movements such as significant chronic lower back pain or neck pain
- Unstable or severe chronic lung conditions
- Current participation in a mind-body practice/program
- Current cancer other than non-melanoma skin cancer
- Regular swimmer
- Plays wind or brass musical instruments
About this study
Official title: Pilot Study for Breathing Interventions in Congestive Heart Failure
Slow breathing may reduce stress. Adults with congestive heart failure have higher stress than the general population. This study will examine if using slow breathing is feasible among adults with heart failure.
- Conditions
- Congestive Heart Failure
- Being tested
- Slow breathing techniques
- Keywords
- Breathing, Mind-body
- Medical subject headings
- Heart Failure, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow breathing techniquesBehavioural
8 sessions of instruction in slow breathing exercises over 12 weeks of study
| Study group | Role | What they receive |
|---|---|---|
| Slow breathing | Experimental | Slow breathing techniques with exhale greater than inhale Receives: Behavioral: Slow breathing techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention administration measured by frequency of visits
Investigators will document weekly attendance
Measured: Weekly for 12 weeks
Feasibility of intervention administration measured by home practice adherence
Investigators will ask participants how often they practiced yoga at home since last session
Measured: Weekly for 12 weeks
Feasibility of intervention administration measured by patient satisfaction
A survey will be administered that assesses participant satisfaction with the yoga. Overall satisfaction will be assessed by "Very Unsatisfied", "Unsatisfied", "Satisfied", "Very Satisfied".
Measured: One time, at 12 week survey
Safety of yoga practice as measured by occurrence of adverse events
Investigators will monitor for adverse events related to yoga practice during the intervention and will solicit any adverse events during home practice since last meeting.
Measured: Weekly for 12 weeks
Secondary outcomes (7)
Magnitude of change in PROMIS Depression scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Computer Adaptive Test (CAT). The PROMIS Depression instruments assess self-reported negative mood (sadness, guilt), views of self (selfcriticism, worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose). With CAT, participant responses guide the system's choice of subsequent items from the full item bank (28 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of depression.
Measured: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Anxiety scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computer Adaptive Test (CAT). The PROMIS Anxiety instruments measure self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). With CAT, participant responses guide the system's choice of subsequent items from the full item bank (29 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of anxiety.
Measured: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Global Health scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. The PROMIS Global Health measures assess an individual's physical, mental, and social health. Each of the 10 items are totaled into a raw sum score and Raw Sum Scores are then converted into T-Scores. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of physical, mental, and social health.
Measured: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Physical Function scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (CAT). PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (165 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of physical functioning.
Measured: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Fatigue scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Computer Adaptive Test (CAT). The PROMIS Fatigue instruments evaluate a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (95 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of fatigue.
Measured: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Dyspnea scale
Patient-Reported Outcomes Measurement Information System (PROMIS) Dyspnea Severity Computer Adaptive Test (CAT). The PROMIS Dyspnea instruments evaluate a range of self-reported symptoms related to dyspnea. With CAT, participant responses guide the system's choice of subsequent items from the full item bank (33 items in total) and a T-Score is generated. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A higher score reflects higher levels of dyspnea.
Measured: Baseline, 6 week, 12 week
Autonomic tone
The investigators will estimate autonomic tone of participants by extracting data from implantable cardioverter defibrillator (ICD). Data analyses will consist of heart rate spectral analyses.
Measured: Monthly data extraction from ICD: Baseline, week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study startNov 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Why it stopped: PI left VUMC
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449121
- Sponsor's protocol ID
- 171991
- Status last verified
- Feb 2019
- First submitted
- 31 Jan 2018
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Breathing Interventions in Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT03449121
- Acronym / sponsor ID
- 171991
- Conditions
- Congestive Heart Failure
- Keywords
- Breathing, Mind-body
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left VUMC
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 28 Feb 2018 (actual)
- 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.
Slow breathing may reduce stress. Adults with congestive heart failure have higher stress than the general population. This study will examine if using slow breathing is feasible among adults with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Slow breathing | Experimental | Behavioral: Slow breathing techniquesSlow breathing techniques with exhale greater than inhale |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented heart failure from medical chart review with signs and symptoms consistent with disease
- Reduced left ventricular function with ejection fraction of less than or equal to 40%
- English speaking
Key exclusion criteria (19 listed)
- New York Heart Failure Association Class I or IV
- Myocardial infarction in the last 3 months
- Cardiac surgery in the last 3 months
- Significant valvular heart disease
- Uncontrolled cardiac arrhythmias
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 breathing techniques8 sessions of instruction in slow breathing exercises over 12 weeks of study | Behavioural | Slow breathing |
Primary outcome
Feasibility of intervention administration measured by frequency of visits
Time frame: Weekly for 12 weeks
Investigators will document weekly attendance
Feasibility of intervention administration measured by home practice adherence
Time frame: Weekly for 12 weeks
Investigators will ask participants how often they practiced yoga at home since last session
Feasibility of intervention administration measured by patient satisfaction
Time frame: One time, at 12 week survey
A survey will be administered that assesses participant satisfaction with the yoga. Overall satisfaction will be assessed by "Very Unsatisfied", "Unsatisfied", "Satisfied", "Very Satisfied".
Safety of yoga practice as measured by occurrence of adverse events
Time frame: Weekly for 12 weeks
Investigators will monitor for adverse events related to yoga practice during the intervention and will solicit any adverse events during home practice since last meeting.
7 secondary outcomes
Magnitude of change in PROMIS Depression scale
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Anxiety scale
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Global Health scale
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Physical Function scale
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Fatigue scale
Time frame: Baseline, 6 week, 12 week
Magnitude of change in PROMIS Dyspnea scale
Time frame: Baseline, 6 week, 12 week
Autonomic tone
Time frame: Monthly data extraction from ICD: Baseline, week 4, week 8, week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Individual participant dataSharing planned: No
Related trials for Congestive Heart Failure
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Notification Of High-Risk Veterans for Access to Heart Failure Prevention
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Slow breathing techniques in people with Congestive Heart Failure, run by Vanderbilt University Medical Center.
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 3 inclusion and 19 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: withdrawn, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Feasibility of intervention administration measured by frequency of visits (time frame: Weekly for 12 weeks). The study lists 4 primary outcomes in all. 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 4 Mar 2019; AzTrials last refreshed its copy on 3 Nov 2026.