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

Primary Purpose

Hypertension, Hypertensive Heart Disease, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Renal denervation
Medical therapy
Sponsored by
Pace Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring hypertension, hypertensive heart disease, atrial fibrillation, autonomic imbalance

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pace Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Renal denervation

Medical therapy

Arm Description

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.

This group will not receive renal sympathetic denervation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2013
Last Updated
September 27, 2022
Sponsor
Pace Clinic
Collaborators
University Hospital, Saarland
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1. Study Identification

Unique Protocol Identification Number
NCT01990911
Brief Title
Renal Sympathetic Denervation Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study
Acronym
RDPAF
Official Title
Renal Sympathetic Denervation Restores Autonomic Imbalance and Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 6, 2022 (Actual)
Study Completion Date
June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pace Clinic
Collaborators
University Hospital, Saarland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypertensive Heart Disease, Atrial Fibrillation, Autonomic Imbalance
Keywords
hypertension, hypertensive heart disease, atrial fibrillation, autonomic imbalance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal denervation
Arm Type
Experimental
Arm Description
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.
Arm Title
Medical therapy
Arm Type
Sham Comparator
Arm Description
This group will not receive renal sympathetic denervation
Intervention Type
Device
Intervention Name(s)
Renal denervation
Other Intervention Name(s)
Symplicity catheter renal denervation
Intervention Description
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
Drug
Intervention Name(s)
Medical therapy
Other Intervention Name(s)
Three or more blood pressure tablets, including a diuretic
Intervention Description
Subjects will continue on their standard medical therapy as prescribed by their treating physician
Primary Outcome Measure Information:
Title
Atrial fibrillation
Description
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).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Restoration of autonomic imbalance
Description
Restoration of autonomic imbalance: lowering resting heart rate, prolonging the PR-interval and improving heart rate recovery after exercise.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Brink, PhD
Organizational Affiliation
Tygerberg Hospital and Stellenbosch University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Michael Bohm, PhD
Organizational Affiliation
University Hospital, Saarland
Official's Role
Study Director
Facility Information:
Facility Name
Pace Clinic
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
35781044
Citation
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 Jun 30:S1547-5271(22)02160-9. doi: 10.1016/j.hrthm.2022.06.031. Online ahead of print.
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Renal Sympathetic Denervation Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study

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