ArrhythmiaBETANCT00754663
Exercise Training in Patients With Cardioverter-Defibrillators
A study testing exercise training in people with Arrhythmia, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Exercise therapy has proven to be an effective additive therapy in patients with cardiovascular diseases. The prognostic value of physical activity is well established in patients with congestive heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Nov 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both gender at a minimum age of 18 years
- ICD-systems with "Cardiac-Compass" (Medtronic)-diagnostic feature
- ICD system implanted for at least three months
- congestive heart failure, NYHA II and III
- LVEF ≤ 40 %
- compensated state, optimized and stable pharmacological therapy at least for the last three months
- load capacity of at least 50 watt at baseline.
Who cannot join
- unable or unwilling to give informed consent
- acute coronary syndrome during the past thirty days
- hemodynamically relevant valvular defect
- instable arterial hypertension
- severe COPD
- reduced work load capacity caused by instable angina pectoris, peripheral vascular, neurological or orthopaedic concomitant disease
- hypertrophic obstructive cardiomyopathy (HOCM)
- pulmonary-arterial hypertension (PAP systolic ≥ 60 mmHg).
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Clinic, Dept. of Cardiology
Tübingen, Baden-Wurttemberg, 72076
Slawomir Weretka, MD, +49 7071 29 83196, weretka@hotmail.com
Jürgen Schreieck, MD, +49 7071 29 82711 ext. 8781, juergen.schreieck@med.uni-tuebingen.de
About this study
Official title: BETA: Beneficial Effects of Exercise Training in Patients With Implantable Cardioverter-Defibrillators
Exercise therapy has proven to be an effective additive therapy in patients with cardiovascular diseases. The prognostic value of physical activity is well established in patients with congestive heart failure. Therefore the investigators assumed that the population of patients with implantable cardioverter-defibrillators (ICD) with impaired left ventricular function may also benefit from a cardiovascular training in terms of improved quality of life and reduction of ventricular arrhythmia. The data on feasibility, risk and therapeutic effects of exercise training are very limited or not available.
This prospective randomized study examines the feasibility and benefits of exercise therapy in patients with ICD and congestive heart failure.
Read the detailed description
Detailed anamnesis and a clinical examination will be performed in order to determine the patient's eligibility for the study. The randomisation either to the exercise- or to the control-arm will be performed at baseline. Follow-up visits are planned after four weeks and after three months same for both arms. The close-up visit is planned after 6 months.
The exercise-arm starts off with an introduction into physical training at the Department of Sports Medicine at the University in Tübingen. Ergospirometry and 6-min walk test will be performed to determine the patients' performance. Then the patients will be encouraged to exercise at home. The scales and intensities of physical training will vary interpersonally depending on patients individual performance. Pedometers and the ICD-integrated "Cardiac Compass" function will be used to verify work load, intensity and duration of the physical strain. The patients will be consulted by telephone regularly to affirm the study compliance. The physical activity in the control-arm will be monitored using the ICD-integrated "Cardiac Compass" function.
ICD-programming
- VT/SVT discrimination "on",
- "Cardiac Compass" feature "on"
- VT/VF detection and pacing-programming remain adjusted to clinical situation of the patient
Baseline- and follow-up visits
- Anamnesis, NYHA-stadium, patients' demographic data: sex, age, weight, hight, concomitant diseases and current medication
- Clinical examination: weight, inflow-congestion, edema, pulmonary signs of cardiac decompensation
- Chest- x-ray (baseline, 6 moths FU)
- 6-min walk test (baseline, 6 moths FU)
- Blood take (baseline, 6 moths FU) standard examinations including blood morphology, troponin, renal retention parameters, transaminases)
- Determination of the BNP plasma level
- Echocardiography (baseline, 6 moths FU): left-ventricular function (EF) and diameter, valvular function, estimating of systolic pulmonary arterial pressure (PAP sys.).
- Ergospirometry (baseline, 6 moths FU):peak-oxygen-uptake-volume, starting at 10 Watt with increase of the work load 12 Watts per minute until the work load capacity has been reached. The achieved VO2 value is defined as the 100 % oxygen-uptake. At home the patients are supposed to exercise at about 70 % of their VO2 peak.
- Measurement/Recording of the peripheral oxygen-uptake of the muscle with near-infrared-spectroscopy simultaneously with the bicycle-ergometric exposure.
- Complete interrogation of the ICD-memory, acquisition of the "Cardiac-Compass"-data, sensing- and threshold-test, recording of electrical impedance and checking of the battery-status, impedance and checking of the battery-status
- Acquisition of the standardized questionnaires concerning quality-of-life, personality, depression and anxiety: PHQ-D, DS14, FSGV 1.0 and GAD-7.
Definition of adverse event
- Adverse event (AE): Any decrease of existential orientation, unwanted incidence, subjective or objective symptom of any kind of disease, impairment or any accident, that may or may not be connected to the study is defined as an (AE).
- Severe adverse event (SAE): A SAE is an event which is life-threatening or deadly, causes significant or chronic damage, requires hospitalization or threatens the patient's physical inviolability in any other way.
- Conditions
- Arrhythmia
- Being tested
- exercise training
- Keywords
- exercise, implantable cardioverter-defibrillator, arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
walking training at least 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | exercise training Receives: Behavioral: exercise training |
| 2 | Placebo comparator | control arm: normal behavior, no additional exercise will be advised Receives: Behavioral: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of arrhythmia burden, heart rate trend, increase in patients activity.
Measured: 6 months
Secondary outcomes (1)
Ineffective ICD-interventions, injury risk due to syncope, hospitalization, death. LVEF (echocardiography), VO2max, anaerobic threshold (AT), respiratory compensation point (RCP) and equivalents for O2 and CO2 (ergospirometry) BNP plasma level
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Slawomir Weretka, MD, Principal investigator, University Hospital TuebingenJuergen Schreieck, MD, Study chair, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00754663
- Sponsor's protocol ID
- 01
- Acronym
- BETA
- Status last verified
- Sep 2008
- First submitted
- 4 Aug 2008
- Last updated
- 18 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Lakka TA, Venalainen JM, Rauramaa R, Salonen R, Tuomilehto J, Salonen JT. Relation of leisure-time physical activity and cardiorespiratory fitness to the risk of acute myocardial infarction. N Engl J Med. 1994 Jun 2;330(22):1549-54. doi: 10.1056/NEJM199406023302201.
PubMed 8177243Schuler G. [Physical activity]. Z Kardiol. 2005;94 Suppl 3:III/11-4. doi: 10.1007/s00392-005-1303-1. German.
PubMed 16258787Dursch M, Schulz O. [Restructuring cardiovascular exercise therapy in Germany with reference to current international guidelines]. Herz. 2003 Aug;28(5):349-58. doi: 10.1007/s00059-003-2438-3. German.
PubMed 12928734Schulz O, Dursch M. [From bench to bicycle. Risk assessment in connection with sports activities and exercise programs in the primary and secondary prevention of cardiovascular diseases]. Herz. 2003 Aug;28(5):359-73. doi: 10.1007/s00059-003-2463-9. German.
PubMed 12928735Erbs S, Linke A, Gielen S, Fiehn E, Walther C, Yu J, Adams V, Schuler G, Hambrecht R. Exercise training in patients with severe chronic heart failure: impact on left ventricular performance and cardiac size. A retrospective analysis of the Leipzig Heart Failure Training Trial. Eur J Cardiovasc Prev Rehabil. 2003 Oct;10(5):336-44. doi: 10.1097/01.hjr.0000099031.38268.27.
PubMed 14663295Hambrecht R, Gielen S, Linke A, Fiehn E, Yu J, Walther C, Schoene N, Schuler G. Effects of exercise training on left ventricular function and peripheral resistance in patients with chronic heart failure: A randomized trial. JAMA. 2000 Jun 21;283(23):3095-101. doi: 10.1001/jama.283.23.3095.
PubMed 10865304Belardinelli R, Georgiou D, Cianci G, Purcaro A. Randomized, controlled trial of long-term moderate exercise training in chronic heart failure: effects on functional capacity, quality of life, and clinical outcome. Circulation. 1999 Mar 9;99(9):1173-82. doi: 10.1161/01.cir.99.9.1173.
PubMed 10069785Kamke W, Dovifat C, Schranz M, Behrens S, Moesenthin J, Voller H. Cardiac rehabilitation in patients with implantable defibrillators. Feasibility and complications. Z Kardiol. 2003 Oct;92(10):869-75. doi: 10.1007/s00392-003-0997-1.
PubMed 14579052Vanhees L, Schepers D, Heidbuchel H, Defoor J, Fagard R. Exercise performance and training in patients with implantable cardioverter-defibrillators and coronary heart disease. Am J Cardiol. 2001 Mar 15;87(6):712-5. doi: 10.1016/s0002-9149(00)01488-0.
PubMed 11249888Vanhees L, Kornaat M, Defoor J, Aufdemkampe G, Schepers D, Stevens A, Van Exel H, Van Den Beld J, Heidbuchel H, Fagard R. Effect of exercise training in patients with an implantable cardioverter defibrillator. Eur Heart J. 2004 Jul;25(13):1120-6. doi: 10.1016/j.ehj.2004.04.034.
PubMed 15231370Lampert R, Cannom D, Olshansky B. Safety of sports participation in patients with implantable cardioverter defibrillators: a survey of heart rhythm society members. J Cardiovasc Electrophysiol. 2006 Jan;17(1):11-5. doi: 10.1111/j.1540-8167.2005.00331.x.
PubMed 16426392Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.
PubMed 16160202
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BETA: Beneficial Effects of Exercise Training in Patients With Implantable Cardioverter-Defibrillators
- ClinicalTrials.gov ID
- NCT00754663
- Acronym / sponsor ID
- BETA / 01
- Conditions
- Arrhythmia
- Keywords
- exercise, implantable cardioverter-defibrillator, arrhythmia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 18 Sep 2008 (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.
Exercise therapy has proven to be an effective additive therapy in patients with cardiovascular diseases. The prognostic value of physical activity is well established in patients with congestive heart failure. Therefore the investigators assumed that the population of patients with implantable cardioverter-defibrillators (ICD) with impaired left ventricular function may also benefit from a cardiovascular training in terms of improved quality of life and reduction of ventricular arrhythmia. The data on feasibility, risk and therapeutic effects of exercise training are very limited or not available.
This prospective randomized study examines the feasibility and benefits of exercise therapy in patients with ICD and congestive heart failure.
Detailed description
Detailed anamnesis and a clinical examination will be performed in order to determine the patient's eligibility for the study. The randomisation either to the exercise- or to the control-arm will be performed at baseline. Follow-up visits are planned after four weeks and after three months same for both arms. The close-up visit is planned after 6 months.
The exercise-arm starts off with an introduction into physical training at the Department of Sports Medicine at the University in Tübingen. Ergospirometry and 6-min walk test will be performed to determine the patients' performance. Then the patients will be encouraged to exercise at home. The scales and intensities of physical training will vary interpersonally depending on patients individual performance. Pedometers and the ICD-integrated "Cardiac Compass" function will be used to verify work load, intensity and duration of the physical strain. The patients will be consulted by telephone regularly to affirm the study compliance. The physical activity in the control-arm will be monitored using the ICD-integrated "Cardiac Compass" function.
ICD-programming
- VT/SVT discrimination "on",
- "Cardiac Compass" feature "on"
- VT/VF detection and pacing-programming remain adjusted to clinical situation of the patient
Baseline- and follow-up visits
- Anamnesis, NYHA-stadium, patients' demographic data: sex, age, weight, hight, concomitant diseases and current medication
- Clinical examination: weight, inflow-congestion, edema, pulmonary signs of cardiac decompensation
- Chest- x-ray (baseline, 6 moths FU)
- 6-min walk test (baseline, 6 moths FU)
- Blood take (baseline, 6 moths FU) standard examinations including blood morphology, troponin, renal retention parameters, transaminases)
- Determination of the BNP plasma level
- Echocardiography (baseline, 6 moths FU): left-ventricular function (EF) and diameter, valvular function, estimating of systolic pulmonary arterial pressure (PAP sys.).
- Ergospirometry (baseline, 6 moths FU):peak-oxygen-uptake-volume, starting at 10 Watt with increase of the work load 12 Watts per minute until the work load capacity has been reached. The achieved VO2 value is defined as the 100 % oxygen-uptake. At home the patients are supposed to exercise at about 70 % of their VO2 peak.
- Measurement/Recording of the peripheral oxygen-uptake of the muscle with near-infrared-spectroscopy simultaneously with the bicycle-ergometric exposure.
- Complete interrogation of the ICD-memory, acquisition of the "Cardiac-Compass"-data, sensing- and threshold-test, recording of electrical impedance and checking of the battery-status, impedance and checking of the battery-status
- Acquisition of the standardized questionnaires concerning quality-of-life, personality, depression and anxiety: PHQ-D, DS14, FSGV 1.0 and GAD-7.
Definition of adverse event
- Adverse event (AE): Any decrease of existential orientation, unwanted incidence, subjective or objective symptom of any kind of disease, impairment or any accident, that may or may not be connected to the study is defined as an (AE).
- Severe adverse event (SAE): A SAE is an event which is life-threatening or deadly, causes significant or chronic damage, requires hospitalization or threatens the patient's physical inviolability in any other way.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: exercise trainingexercise training |
| 2 | Placebo comparator | Behavioral: exercise trainingcontrol arm: normal behavior, no additional exercise will be advised |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- both gender at a minimum age of 18 years
- ICD-systems with "Cardiac-Compass" (Medtronic)-diagnostic feature
- ICD system implanted for at least three months
- congestive heart failure, NYHA II and III
- LVEF ≤ 40 %
Key exclusion criteria (8 listed)
- unable or unwilling to give informed consent
- acute coronary syndrome during the past thirty days
- hemodynamically relevant valvular defect
- instable arterial hypertension
- severe COPD
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 |
|---|---|---|
| exercise trainingwalking training at least 3 times a week | Behavioural | 1, 2 |
Primary outcome
Reduction of arrhythmia burden, heart rate trend, increase in patients activity.
Time frame: 6 months
1 secondary outcome
Ineffective ICD-interventions, injury risk due to syncope, hospitalization, death. LVEF (echocardiography), VO2max, anaerobic threshold (AT), respiratory compensation point (RCP) and equivalents for O2 and CO2 (ergospirometry) BNP plasma level
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2008.
- Background: PubMed 8177243Lakka TA, Venalainen JM, Rauramaa R, Salonen R, Tuomilehto J, Salonen JT. Relation of leisure-time physical activity and cardiorespiratory fitness to the risk of acute myocardial infarction. N Engl J Med. 1994 Jun 2;330(22):1549-54. doi: 10.1056/NEJM199406023302201.
- Background: PubMed 16258787Schuler G. [Physical activity]. Z Kardiol. 2005;94 Suppl 3:III/11-4. doi: 10.1007/s00392-005-1303-1. German.
- Background: PubMed 12928734Dursch M, Schulz O. [Restructuring cardiovascular exercise therapy in Germany with reference to current international guidelines]. Herz. 2003 Aug;28(5):349-58. doi: 10.1007/s00059-003-2438-3. German.
- Background: PubMed 12928735Schulz O, Dursch M. [From bench to bicycle. Risk assessment in connection with sports activities and exercise programs in the primary and secondary prevention of cardiovascular diseases]. Herz. 2003 Aug;28(5):359-73. doi: 10.1007/s00059-003-2463-9. German.
- Background: PubMed 14663295Erbs S, Linke A, Gielen S, Fiehn E, Walther C, Yu J, Adams V, Schuler G, Hambrecht R. Exercise training in patients with severe chronic heart failure: impact on left ventricular performance and cardiac size. A retrospective analysis of the Leipzig Heart Failure Training Trial. Eur J Cardiovasc Prev Rehabil. 2003 Oct;10(5):336-44. doi: 10.1097/01.hjr.0000099031.38268.27.
- Background: PubMed 10865304Hambrecht R, Gielen S, Linke A, Fiehn E, Yu J, Walther C, Schoene N, Schuler G. Effects of exercise training on left ventricular function and peripheral resistance in patients with chronic heart failure: A randomized trial. JAMA. 2000 Jun 21;283(23):3095-101. doi: 10.1001/jama.283.23.3095.
- Background: PubMed 10069785Belardinelli R, Georgiou D, Cianci G, Purcaro A. Randomized, controlled trial of long-term moderate exercise training in chronic heart failure: effects on functional capacity, quality of life, and clinical outcome. Circulation. 1999 Mar 9;99(9):1173-82. doi: 10.1161/01.cir.99.9.1173.
- Background: PubMed 14579052Kamke W, Dovifat C, Schranz M, Behrens S, Moesenthin J, Voller H. Cardiac rehabilitation in patients with implantable defibrillators. Feasibility and complications. Z Kardiol. 2003 Oct;92(10):869-75. doi: 10.1007/s00392-003-0997-1.
- Background: PubMed 11249888Vanhees L, Schepers D, Heidbuchel H, Defoor J, Fagard R. Exercise performance and training in patients with implantable cardioverter-defibrillators and coronary heart disease. Am J Cardiol. 2001 Mar 15;87(6):712-5. doi: 10.1016/s0002-9149(00)01488-0.
- Background: PubMed 15231370Vanhees L, Kornaat M, Defoor J, Aufdemkampe G, Schepers D, Stevens A, Van Exel H, Van Den Beld J, Heidbuchel H, Fagard R. Effect of exercise training in patients with an implantable cardioverter defibrillator. Eur Heart J. 2004 Jul;25(13):1120-6. doi: 10.1016/j.ehj.2004.04.034.
- Background: PubMed 16426392Lampert R, Cannom D, Olshansky B. Safety of sports participation in patients with implantable cardioverter defibrillators: a survey of heart rhythm society members. J Cardiovasc Electrophysiol. 2006 Jan;17(1):11-5. doi: 10.1111/j.1540-8167.2005.00331.x.
- Background: PubMed 16160202Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. doi: 10.1161/CIRCULATIONAHA.105.167586. Epub 2005 Sep 13. No abstract available.
- Study projects/ Dept. of Cardiology Electrophysiology, Univ. Clinic TübingenLink provided by the sponsor.
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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.
Slawomir Weretka, MD principal investigator
University Hospital Tuebingen
Juergen Schreieck, MD study chair
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Arrhythmia, run by University Hospital Tuebingen at 1 site in Germany.
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 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: status not confirmed, as of the sponsor's last update on 18 Sep 2008. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Slawomir Weretka, MD (+49 7071 29 83196, weretka@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of arrhythmia burden, heart rate trend, increase in patients activity. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00754663, which also lists 12 linked publications.
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 18 Sep 2008.