Heart FailureNCT02358525
Effects of a Rehabilitation Program on Immune Activation and Mood in Heart Failure Patients
An observational study of Heart Failure and Depressive Symptoms, run by Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation at 2 sites in Austria.
Trial summary
The aim of this descriptive study is to examine potential changes regarding inflammatory cytokine levels, depressive symptoms and quality of life over the course of the 4-week inpatient rehabilitation program which includes a cassette of modalities including counseling, psychosocial education and supervised exercise… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Depressive Symptoms
- What is being tested?
- multi-modality rehabilitation program for heart failure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 2 sitesAustria
- Study dates
- Jan 2015to Feb 2016
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients, EF ≤ 45%, NYHA I - III; ACC/AHA stage C
Who may be able to join
- Diagnosis of heart failure with reduced ejection fraction (HFREF) with an EF ≤ 45%, NYHA (New York Heart Association) I - III; ACC/AHA (American College of Cariology/ American Heart Association) stage C, irrespective of etiology
- Clinically stable patients without deterioration or hospitalization due to heart failure within the last 4 weeks
- Neuro-hormonal medication according to the ESC (European Society of Cardiology) guidelines for the treatment of chronic heart failure consisting of antagonists of the Renin-Angiotensin-Aldosterone System (RAAS) and beta-blockers as indicated.
- Ability to fully understand all elements of and sign the written informed consent before initiation of the study
Who cannot join
- Fluid retention of cardiac decompensation, necessitating i.v. diuretic therapy
- Myocardial infarction within the last 2 months
- Surgery including cardiovascular or valvular surgery within 3 Months
- Uncontrolled proinflammatory comorbidities (e.g. Diabetes mellitus HbA1c >9%, COPD ( chronic obstructive pulmonary disease) >II, active rheumatic diseases and autoimmune disorders)
- Current infectious diseases ( e.g. pneumonia, COPD exacerbations or urinary tract infections)
- Morbid obesity: BMI > 40
- Alcohol or drug abuse
- psychiatric disorders
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Ska Rz Grossgmain
Grossgmain, State of Salzburg, 5084
SALK, 2.Medizin, HI-Ambulanz
Salzburg, State of Salzburg, 5020
About this study
Official title: Effects of a Multi-Modality Rehabilitation Program on Immune Activation, Depressive Symptoms and Quality of Life in Heart Failure Patients. A Pilot Study
The aim of this descriptive study is to examine potential changes regarding inflammatory cytokine levels, depressive symptoms and quality of life over the course of the 4-week inpatient rehabilitation program which includes a cassette of modalities including counseling, psychosocial education and supervised exercise training as a main pillar, and to further investigate if there are correlations between changes in immune regulation, depressive symptoms and quality of life.
- Conditions
- Heart Failure, Depressive Symptoms
- Being tested
- multi-modality rehabilitation program for heart failure
- Medical subject headings
- Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-modality rehabilitation program for heart failureBehavioural
rehabilitation consists of supervised exercise training, both endurance and strength, as well as gymnastics, diet and psychosocial education around living with heart failure
What is being measured
The primary outcome is the main question the study is designed to answer.
inflammatory activity
levels of inflammatory biomarkers: Interleukin - 6, Tumor Necrosis Factor-alpha, Interleukin-1beta, Cellular Adhesion Molecule-1
Measured: 8 weeks
Secondary outcomes (3)
physical fitness
6-min-walk test
Measured: 8 weeks
Quality of Life
questionnaires: SF-36 (short-form-36), KCCQ (Kansas City Cardiomyopathy Questionnaire), EQoL-5D (European Quality of LIfe-5Dimensions)
Measured: 8 weeks
Depressive Symptoms
questionnaire: HADS (Hospital Anxiety and Depression Scale)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionFeb 2016
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Katherine Wachmann, Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation
- Investigators
- katherine wachmann, Dr., Principal investigator, Ludwig Boltzmann IRBR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358525
- Sponsor's protocol ID
- J3256
- Status last verified
- Mar 2016
- First submitted
- 19 Nov 2014
- Last updated
- 2 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multi-Modality Rehabilitation Program on Immune Activation, Depressive Symptoms and Quality of Life in Heart Failure Patients. A Pilot Study
- ClinicalTrials.gov ID
- NCT02358525
- Acronym / sponsor ID
- J3256
- Conditions
- Heart Failure, Depressive Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und RehabilitationUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Feb 2015 (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.
The aim of this descriptive study is to examine potential changes regarding inflammatory cytokine levels, depressive symptoms and quality of life over the course of the 4-week inpatient rehabilitation program which includes a cassette of modalities including counseling, psychosocial education and supervised exercise training as a main pillar, and to further investigate if there are correlations between changes in immune regulation, depressive symptoms and quality of life.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients, EF ≤ 45%, NYHA I - III; ACC/AHA stage C
Key inclusion criteria (4 listed)
- Diagnosis of heart failure with reduced ejection fraction (HFREF) with an EF ≤ 45%, NYHA (New York Heart Association) I - III; ACC/AHA (American College of Cariology/ American Heart Association) stage C, irrespective of etiology
- Clinically stable patients without deterioration or hospitalization due to heart failure within the last 4 weeks
- Neuro-hormonal medication according to the ESC (European Society of Cardiology) guidelines for the treatment of chronic heart failure consisting of antagonists of the Renin-Angiotensin-Aldosterone System (RAAS) and beta-blockers as indicated.
- Ability to fully understand all elements of and sign the written informed consent before initiation of the study
Key exclusion criteria (8 listed)
- Fluid retention of cardiac decompensation, necessitating i.v. diuretic therapy
- Myocardial infarction within the last 2 months
- Surgery including cardiovascular or valvular surgery within 3 Months
- Uncontrolled proinflammatory comorbidities (e.g. Diabetes mellitus HbA1c >9%, COPD ( chronic obstructive pulmonary disease) >II, active rheumatic diseases and autoimmune disorders)
- Current infectious diseases ( e.g. pneumonia, COPD exacerbations or urinary tract infections)
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 |
|---|---|---|
| multi-modality rehabilitation program for heart failurerehabilitation consists of supervised exercise training, both endurance and strength, as well as gymnastics, diet and psychosocial education around living with heart failure | Behavioural | – |
Primary outcome
inflammatory activity
Time frame: 8 weeks
levels of inflammatory biomarkers: Interleukin - 6, Tumor Necrosis Factor-alpha, Interleukin-1beta, Cellular Adhesion Molecule-1
3 secondary outcomes
physical fitness
Time frame: 8 weeks
Quality of Life
Time frame: 8 weeks
Depressive Symptoms
Time frame: 8 weeks
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 2 Mar 2016.
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A Study of Bimagrumab in Participants With HFpEF
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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.
katherine wachmann, Dr. principal investigator
Ludwig Boltzmann IRBR
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Depressive Symptoms, run by Ludwig-Boltzmann Institut fuer Rheumatologie, Balneologie und Rehabilitation at 2 sites in Austria.
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 4 inclusion and 8 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 2 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
inflammatory activity (time frame: 8 weeks). 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 2 Mar 2016.