Trial on the effect of biventricUlar pacinG in patients with bradycardia prEserved LV functioN, with the aim of Decreasing Heart failure and ATrial fibrillation.
| ISRCTN | ISRCTN04561582 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04561582 |
| Secondary identifying numbers | NR9190-3/2007 |
- Submission date
- 27/05/2011
- Registration date
- 16/08/2011
- Last edited
- 16/08/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Milos Taborsky
Scientific
Scientific
Olomouc University Hospital
Department of Internal Medicine Cardiology
I.P.Pavlova 6
Olomouc
775 20
Czech Republic
Study information
| Study design | The multicentre, observational, prospective study with 5 years follow-up visits |
|---|---|
| Primary study design | Observational |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | TUGENDHAT Study |
| Study acronym | TUGENDHAT |
| Study objectives | Aim of this study is to compare standard AV sequential pacing versus biventricular pacing in the patients with conventional indication for permanent heart pacing (primary bradycardia indication) accompanied by documented left ventricular dysfunction. |
| Ethics approval(s) | Homolce Hospital Ethics Committee, 12 June 2008, ref: IBA-KS-2008-01 - Tugendhat |
| Health condition(s) or problem(s) studied | AV block, Sick Sinus Syndrome - Bradycardia form |
| Intervention | 1. The study contains 120 patients randomized into right ventricular and biventricular pacing group with cross-over switch of pacing modes after six months 2. Standard descriptive statistics will be used for the analysis, continuous paremeters as age, weight, body mass index were described by median and fifth and ninety-fifth percentile, occurence of categorical parameters was described by their count and percentages. |
| Intervention type | Other |
| Primary outcome measure | 1. Electrocardiographic parameters (ECG) 2. Echocardiographic parameters (LV Ejection Fraction) 3. Evaluation of NYHA class 4. Evaluation of Quality of Live (Minnesota Living with Heart Failure questionnaire) |
| Secondary outcome measures | Atrial Fibrillation burden hospitalization for Heart Failure complication of pacing |
| Overall study start date | 01/07/2008 |
| Completion date | 01/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 - 60 in each arm |
| Key inclusion criteria | 1. Bradycardia pacing indication 2. Subject has stable medication (nitrates, diuretics, betablockers) within the last 3 months 3. Echocardiographic exclusion of ventricular (inter-and intra) dyssynchrony 4. Willing and able to comply with the Clinical investigation Plan 5. Signed Informed consent form 6. Aavailability for follow-up visits |
| Key exclusion criteria | 1. Age less 18 years 2. Indication for biventricular pacing 3. LV EF less than15% 4. Stable NYHA IV 5. Intravenous diuretics, ionotropics medication 6. Enrollment in a concurrent study that may confound the results of this study 7. Post heart transplant or awaiting heart transplantation 8. Renal insufficiency requiring dialiysis 9. Anticipation of poor compliance 10. Pregnancy 11. Life expectancy less than 12 months 12. The inform consent form not signed |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 01/12/2015 |
Locations
Countries of recruitment
- Czech Republic
Study participating centre
Olomouc University Hospital
Olomouc
775 20
Czech Republic
775 20
Czech Republic
Sponsor information
Olomouc University Hospital (Czech Rebublic)
Hospital/treatment centre
Hospital/treatment centre
c/o Prof Milos Taborsky MD, PhD, FESC, MBA
Department of Internal Medicine Cardiology
I.P.Pavlova 6
Olomouc
77520
Czech Republic
| Website | http://www.fnol.cz/i--interni-klinika---kardiologicka_3.html |
|---|---|
"ROR" |
https://ror.org/01jxtne23 |
Funders
Funder type
Research organisation
IGA (Czech Republic), ref: NR9190-3/2007
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
