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

NCT ID: NCT01990911

Last Updated: 2022-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2022-06-06

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.

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.

Conditions

Hypertension; Hypertensive Heart Disease; Atrial Fibrillation; Autonomic Imbalance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Renal denervation

Intervention Type: DEVICE

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.

Medical therapy

Intervention Type: DRUG

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

Medical therapy

This group will not receive renal sympathetic denervation

Group Type: SHAM_COMPARATOR

Medical therapy

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

Medical therapy

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

Intervention Type: DRUG

Other Intervention Names

Symplicity catheter renal denervation; Three or more blood pressure tablets, including a diuretic

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Saarland

OTHER

Sponsor Role: collaborator

Pace Clinic

OTHER

Sponsor Role: lead

Responsible Party

Marshall Jacobus Heradien

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul A Brink, PhD

Role: STUDY_DIRECTOR

Tygerberg Hospital and Stellenbosch University

Michael Bohm, PhD

Role: STUDY_DIRECTOR

University Hospital, Saarland

Locations

Pace Clinic

Cape Town, Western Cape, South Africa

Countries

South Africa

References

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, Bohm M, Brink PA. Renal denervation prevents subclinical atrial fibrillation in patients with hypertensive heart disease: Randomized, sham-controlled trial. Heart Rhythm. 2022 Nov;19(11):1765-1773. doi: 10.1016/j.hrthm.2022.06.031. Epub 2022 Jun 30.

Reference Type: BACKGROUND

PMID: 35781044 (View on PubMed)

Other Identifiers

RDPAF1

Identifier Type: -

Identifier Source: org_study_id