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
Protocol serial number	NR9190-3/2007
Sponsor	Olomouc University Hospital (Czech Rebublic)
Funder	IGA (Czech Republic), ref: 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

Olomouc University Hospital
Department of Internal Medicine Cardiology
I.P.Pavlova 6
Olomouc
775 20
Czech Republic

Study information

Primary study design	Observational
Study design	The multicentre, observational, prospective study with 5 years follow-up visits
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	Atrial Fibrillation burden hospitalization for Heart Failure complication of pacing
Completion date	01/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	120
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes