RDPAF: Renal Sympathetic Denervation Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study

Sponsor

Pace Clinic (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01990911

Collaborator

University Hospital, Saarland (Other)

100

Enrollment

Location

Arms

101

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The autonomic nervous system plays an important role in the precipitation of AF in structurally-abnormal hearts. Restoration of autonomic imbalance may therefore prevent new-onset AF.

Renal artery denervation (RDN) is a novel percutaneous procedure that uses radio-frequency energy to destroy the sympathetic renal nerves. Symplicity 1 and -2 studies have shown that RDN effectively reduces blood pressure in up to 80% of treated patients. LVH regression and improvement of diastolic dysfunction follow as a consequence of afterload reduction and renin-angiotensin-aldosterone system modulation. RDN may thus also reduce intra-atrial pressure resulting in less stretch of the pulmonary venous ostia where most ectopic AF-foci originate.

Hypothesis: RDN restores autonomic imbalance in HTHD and lowers intra-atrial pressure by reducing afterload. These synergistic mechanisms may prevent new-onset AF.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Hypertensive Heart Disease Atrial Fibrillation Autonomic Imbalance	Device: Renal denervation Drug: Medical therapy	N/A

Detailed Description

One hundred consenting patients meeting all inclusion criteria will undergo an exercise stress test, 2D and M-Mode echocardiograms and 24-hour ambulatory blood pressure holter monitoring prior to being randomised to receive either renal denervation (RDN) with a Symplicity renal denervation catheter plus medical therapy or medical therapy alone. Coronary angiography with/without coronary revascularisation will be performed as per the treating cardiologist's clinical judgement and a Reveal® holter will be implanted in all patients at the end of the procedure.

Time zero will be defined as starting at three months after the procedure. Follow up visits will be scheduled to scan the holter for the primary end point, i.e. high atrial rates (AF-surrogate defined as: "episodes of atrial rate >190 beats per minute for more than 6 minutes") or new-onset AF. Patients will be followed six monthly for three years.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

Renal Sympathetic Denervation Restores Autonomic Imbalance and Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study

Actual Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Renal denervation Renal denervation: both renal arteries are denervated by applying radio-frequency energy at application points moving in a helical fashion starting in the distal renal artery and moving to the proximal junction with the abdominal aorta.	Device: Renal denervation In patients randomized to intervention both renal arteries will be treated with radio-frequency energy as per standard Symplicity protocol.In patients randomized to medical-treatment group only, sham renal denervation will be performed by only injecting contrast agent into both renal arteries. Other Names: Symplicity catheter renal denervation Drug: Medical therapy Subjects will continue on their standard medical therapy as prescribed by their treating physician Other Names: Three or more blood pressure tablets, including a diuretic
Sham Comparator: Medical therapy This group will not receive renal sympathetic denervation	Drug: Medical therapy Subjects will continue on their standard medical therapy as prescribed by their treating physician Other Names: Three or more blood pressure tablets, including a diuretic

Arm

Intervention/Treatment

Experimental: Renal denervation

Renal denervation: both renal arteries are denervated by applying radio-frequency energy at application points moving in a helical fashion starting in the distal renal artery and moving to the proximal junction with the abdominal aorta.

Device: Renal denervation

In patients randomized to intervention both renal arteries will be treated with radio-frequency energy as per standard Symplicity protocol.In patients randomized to medical-treatment group only, sham renal denervation will be performed by only injecting contrast agent into both renal arteries.

Other Names:

Symplicity catheter renal denervation

Drug: Medical therapy

Subjects will continue on their standard medical therapy as prescribed by their treating physician

Other Names:

Three or more blood pressure tablets, including a diuretic

Sham Comparator: Medical therapy

This group will not receive renal sympathetic denervation

Drug: Medical therapy

Subjects will continue on their standard medical therapy as prescribed by their treating physician

Other Names:

Three or more blood pressure tablets, including a diuretic

Outcome Measures

Primary Outcome Measures

Atrial fibrillation [3 years]
Subclinical atrial tachyarrhythmias (episodes of atrial rate >190 beats per minute for more than 6 minutes) or atrial fibrillation recorded by implantable loop recorder (Reveal® holter).

Secondary Outcome Measures

Restoration of autonomic imbalance [3 years]
Restoration of autonomic imbalance: lowering resting heart rate, prolonging the PR-interval and improving heart rate recovery after exercise.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Must have an indication for coronary angiography e.g.
Acute coronary syndrome
Positive stress ECG: - Defined as ≥1mm ST segment shift (depression or elevation) in ≥2 contiguous leads with/without chest discomfort)
Age ≥55 years
Office blood pressure ≥160/90mmHg in non-diabetics or ≥150/90mmHg in diabetics
Subjects must be on at least 3 anti-hypertensive drugs, including a diuretic agent
Sinus rhythm
Left ventricular hypertrophy defined on echo as:
Estimated LV mass > 255 g or LVMI >131 g/m2 for men
Estimated LV mass >193 g or LVMI >113 g/m2for women
Left atrial diameter ≥45mm on any echocardiographic window