Primary objective is twofold: - To investigate if RDN in combination with PVI prevents AF in patients with AF and with out of range hypertension (systolic >140 mmHg or >130/80 mmHg in diabetics and patients with chronic renal disease) or signs…
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
Hypertensie en signalen van sympathische overactiviteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time to first detection of atrial fibrillation >30 seconds, with the monitoring
period starting 3 months after the intervention.
Secondary outcome
- AF burden after 12 months of follow-up, expressed in % of the monitoring
period, in patients with continuous rhythm monitoring. The monitoring period
starts 3 months after the intervention.
- Blood pressure at 3, 6, 12 months after the intervention, and change in blood
pressure compared to measurement before the intervention
- Blood pressure and heart rate response changes induced by exercise testing
- Changes in heart rate variability measures tested by Holter monitoring
compared to measurement before the intervention
- Changes in arterial stiffness measures post intervention AASI (ambulatory
arterial stiffness index) by ambulatory blood pressure monitoring, PWV (pulse
wave velocity) and augmentation index compared to measurement before the
intervention
Background summary
Atrial fibrillation (AF) is the most common arrhythmia and is poorly controlled
by medication. Ablation therapy (pulmonary vein isolation; PVI) is a class I
indication in AF resistant to medication. In most patients sympathetic
overdrive is a provocative factor inducing AF episodes. Hypertension is very
common in these patients.
Renal denervation (RDN) is a new therapy for therapy resistant hypertension and
its rationale originates in denervating the renal sympathetic efferent and
afferent coupling with the central autonomic nervous system. By denervating the
renal arteries, general sympathetic tone is reduced.
Hypertension is very common in patients with AF. Furthermore, a rise in
sympathetic adrenergic tone can induce AF. We hypothesize that RDN in
combination with PVI will improve the success of ablative therapy. If our study
provides evidence for the effectiveness of RDN in combination with PVI,
Medtronic*s RDN devices could be widely used in patients with AF, undergoing
ablative therapy.
Study objective
Primary objective is twofold:
- To investigate if RDN in combination with PVI prevents AF in patients with AF
and with out of range hypertension (systolic >140 mmHg or >130/80 mmHg in
diabetics and patients with chronic renal disease) or signs of sympathetic
overdrive.
- To investigate if RDN in combination with PVI is more successful in achieving
long term sinus rhythm than PVI alone, in patients with AF and out of range
hypertension or signs of sympathetic overdrive.
Secondary objective(s): To investigate the effects of RDN in combination with
PVI on:
• the general sympathetic drive of the body
• the blood pressure
• the diurnal blood pressure profile
• markers of arterial function and arterial stiffness
Study design
Prospective, randomized, controlled, multicenter, international clinical trial
Intervention
The study population consists of patients with paroxysmal or persistent AF with
out of range hypertension or signs of sympathetic overdrive. Patients will be
randomized into two groups:
Group 1: RDN + PVI
Group 2: PVI
Study burden and risks
RDN and PVI are established as safe therapies for therapy resistant
hypertension and symptomatic atrial fibrillation respectively. Success rates
are 80% for RDN in combination with PVI as treatment of therapy resistant
hypertension and 60% for PVI alone as treatment of AF. The complication risk is
<4% for PVI and is <1% for RDN.
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Dokter van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
The patient falls within the target group resistent hypertension or sympathic overdrive
Patient is an acceptable candidate for renal denervation treatment
Patient is < 75 year of age
Exclusion criteria
Contraindication to chronic anticoagulation therapy or heparin
Previous left heart ablation procedure for AF
Acute coronary syndrome, cardiac surgery, PCI or stroke within 3 months prior to enrolment
Renal artery stenosis >50% of the arterial lumen, or renal artery lumen <=3 mm
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT02115100 |
| CCMO | NL45174.075.13 |