Condition category
Circulatory System
Date applied
27/05/2011
Date assigned
16/08/2011
Last edited
16/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Milos Taborsky

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NR9190-3/2007

Study information

Scientific title

TUGENDHAT Study

Acronym

TUGENDHAT

Study hypothesis

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

Homolce Hospital Ethics Committee, 12 June 2008, ref: IBA-KS-2008-01 - Tugendhat

Study design

The multicentre, observational, prospective study with 5 years follow-up visits

Primary study design

Observational

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/07/2008

Overall trial end date

01/12/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 - 60 in each arm

Participant 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

Recruitment start date

01/07/2008

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Czech Republic

Trial participating centre

Olomouc University Hospital
Olomouc
775 20
Czech Republic

Sponsor information

Organisation

Olomouc University Hospital (Czech Rebublic)

Sponsor details

c/o Prof Milos Taborsky MD
PhD
FESC
MBA
Department of Internal Medicine – Cardiology
I.P.Pavlova 6
Olomouc
77520
Czech Republic

Sponsor type

Hospital/treatment centre

Website

http://www.fnol.cz/i--interni-klinika---kardiologicka_3.html

Funders

Funder type

Research organisation

Funder name

IGA (Czech Republic), ref: NR9190-3/2007

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes