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Trial record 2 of 3 for:    SYMPLICITY AF

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

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ClinicalTrials.gov Identifier: NCT01990911
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
University Hospital, Saarland
Information provided by (Responsible Party):
Marshall Jacobus Heradien, Pace Clinic

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : March 2013
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


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 Name: Symplicity catheter renal denervation

Drug: Medical therapy
Subjects will continue on their standard medical therapy as prescribed by their treating physician
Other Name: 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 Name: Three or more blood pressure tablets, including a diuretic




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990911


Contacts
Contact: Marshall J Heradien, MBChB; M.Med 0027- (0)82-011-8278 marshtan@gmail.com
Contact: Michael Böhm, MD, PhD +49 (0)6841-16-23372 michael.boehm@uniklinikum-saarland.de

Locations
South Africa
Pace Clinic Recruiting
Cape Town, Western Cape, South Africa, 7505
Contact: Marshall J Heradien, MBChB; M.Med    0027(0)82-011-8278    marshtan@gmail.com   
Principal Investigator: Marshall J Heradien, MBChB; M.Med         
Sub-Investigator: Bonke K Khwinani, B.Tec         
Principal Investigator: Michael Bohm, PhD         
Sub-Investigator: Felix Mahfoud, PhD         
Principal Investigator: Paul A Brink, MBChB; PhD         
Sponsors and Collaborators
Pace Clinic
University Hospital, Saarland
Investigators
Study Director: Paul A Brink, PhD Tygerberg Hospital and Stellenbosch University
Study Director: Michael Bohm, PhD University Hospital, Saarland

Responsible Party: Marshall Jacobus Heradien, Dr, Pace Clinic
ClinicalTrials.gov Identifier: NCT01990911     History of Changes
Other Study ID Numbers: RDPAF1
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

Keywords provided by Marshall Jacobus Heradien, Pace Clinic:
hypertension
hypertensive heart disease
atrial fibrillation
autonomic imbalance

Additional relevant MeSH terms:
Hypertension
Atrial Fibrillation
Heart Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes