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

Hypertension Clinical Trial

— RDPAF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990911
• Other study ID #: RDPAF1
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: June 6, 2022

Study information

• Verified date: September 2022
• Source: Pace Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 6, 2022
• Est. primary completion date: June 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Exclusion Criteria:

• Estimated glomerular filtration rate (eGFR) < 45ml/min/1.73m2
• Renal artery anatomy unsuitable for RDN
• Substantial stenotic valvular heart disease
• Pregnancy or planned pregnancy
• Thyrotoxicosis
• Patients needing to undergo coronary artery bypass surgery

Related Conditions & MeSH terms

• Atrial Fibrillation
• Autonomic Imbalance
• Heart Diseases
• Hypertension
• Hypertensive Heart Disease

Intervention

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.

Drug:
• Medical therapy
Subjects will continue on their standard medical therapy as prescribed by their treating physician

Locations

Country	Name	City	State
South Africa	Pace Clinic	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
Pace Clinic	University Hospital, Saarland

Country where clinical trial is conducted

South Africa, 

References & Publications (1)

Heradien M, Mahfoud F, Greyling C, Lauder L, van der Bijl P, Hettrick DA, Stilwaney W, Sibeko S, Jansen van Rensburg R, Peterson D, Khwinani B, Goosen A, Saaiman JA, Ukena C, Böhm M, Brink PA. Renal denervation prevents subclinical atrial fibrillation in patients with hypertensive heart disease: Randomized, sham-controlled trial. Heart Rhythm. 2022 Jun 30. pii: S1547-5271(22)02160-9. doi: 10.1016/j.hrthm.2022.06.031. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation	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).	3 years
Secondary	Restoration of autonomic imbalance	Restoration of autonomic imbalance: lowering resting heart rate, prolonging the PR-interval and improving heart rate recovery after exercise.	3 years

External Links

•   Renal Denervation prevents subclinical atrial fibrillation in patients with hypertensive heart disease: randomized, sham-controlled trial