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

NCT01990911 | Completed DMC

• 1 other identifier: RDPAF1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Hypertensive Heart Disease; Atrial Fibrillation; Autonomic Imbalance

Keywords

hypertension; hypertensive heart disease; atrial fibrillation; autonomic imbalance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Restoration of autonomic imbalance

  3 years

Study Arms (2)

Renal denervation

EXPERIMENTAL

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; Drug: Medical therapy

Medical therapy

SHAM COMPARATOR

This group will not receive renal sympathetic denervation

Drug: Medical therapy

Interventions

Renal denervation 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.

Also known as: Symplicity catheter renal denervation

Renal denervation

Medical therapy DRUG

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

Also known as: Three or more blood pressure tablets, including a diuretic

Medical therapy; Renal denervation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pace Clinic: lead
• University Hospital, Saarland: collaborator

Study Sites (1)

Pace Clinic

Cape Town, Western Cape, 7505, South Africa

Location

Related 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, 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.

  PMID: 35781044 BACKGROUND

MeSH Terms

Conditions

Hypertension; Atrial Fibrillation

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Paul A Brink, PhD

  Tygerberg Hospital and Stellenbosch University

  STUDY DIRECTOR

• Michael Bohm, PhD

  University Hospital, Saarland

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 9, 2013
• First Posted: November 25, 2013
• Study Start: March 1, 2013
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

ZA (1)