Skip to main content
OpenTrials
Completed

NCT Number: NCT01990911

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pace Clinic

Cape Town, Western Cape, 7505, South Africa

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Symplicity catheter renal denervation

Medical Therapy

Drug

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

Primary outcomes

  1. Atrial fibrillation

    Time frame: 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 outcomes

  1. Restoration of autonomic imbalance

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Pace Clinic

Other

Collaborators

  • University Hospital, Saarland

Registry information

Official study title

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

Acronym: RDPAF

Important dates

Study start
2013
Primary completion
2022
Study completion
2022
First posted
Nov 25, 2013
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.