The aim of the substudy is the identification of early (baseline) predictors of heart failure during a relatively high frequency of electrical stiumulation of the right ventricle. How does heart function change over a period of 2 years which…
ID
Source
Brief title
Condition
- Endocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Heart function as measured with sensitive tissue/doppler echocardiography
(including Ejection fraction, right-left ventricular synchrony) and blood
values (BNP).
Secondary outcome
NYHA class (severity of symptoms)
Background summary
Clinical studies have shown that chronic pacing of the right ventricle can lead
to atrial fibrillation and heart failure. The substudy proposes to i)
investigate the changes in heart function over a period of 2 years after the
start of pacing, and ii) map which factors can predict the development of heart
failure in an early stage.
Study objective
The aim of the substudy is the identification of early (baseline) predictors of
heart failure during a relatively high frequency of electrical stiumulation of
the right ventricle. How does heart function change over a period of 2 years
which patients are at the highest risk? This substudy investigates an extended
set of physiological and clinical predictors. Results can contribute to
improved pacing therapies with early intervention in heart failure.
Study design
Prospective, randomised, single blinded, multicenter study in which minimally
25 patients will participate. In the center that has agreed to participate in
the substudy, all patients that have consented to participate in the Minerva
main study will be randomly assigned at baseline to 1 of 3 study groups
(Control/ MVP/ DDDRP group). The patients that are assigned to the control
group will be approached for participation in the substudy. This entails that
the patient undergoes a number of additional measurements during follow ups for
the Minerva main study. Blood sampling and tissue/doppler echocardio-graphy
will take place during baseline, after 1 month, 3, 12 and every following 12
months until the end of the Minerva main study.
Intervention
Patients have an indication for a dual chamber pacemaker and will receive an
Enrhythm device (irrespective of participation in the substudy). There will be
no additional interventions in the substudy.
Study burden and risks
Patients will undergo a number of additional measurements during the follow-up
visits in realtion to the Minerva main study. These additional measurements
entail echocardiography (once) and blood sampling (3-4 times) which sums up to
an extra 100 minutes.
Postbus 2542
6401 DA Heerlen
NL
Postbus 2542
6401 DA Heerlen
NL
Listed location countries
Age
Inclusion criteria
1) Class I/II indication for dual chamber pacemaker
2) Previous implant of an Enrhythm dual chamber pacemaker since max 2 weeks
3) Documented history of atrial arrhythmias in last 12 months
4) Randomised assignment to control group in the Minerva main study
Exclusion criteria
- Younger than 18 years
- History of permanent atrial fibrillation
- Candidates for implantable defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)
- Permanent AV block or AV-node ablation
- Anticipated major cardiac surgery within the course of the study
- Random assignment to DDDRP group or MVP group
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL20183.094.07 |