HypertensionRDPAFNCT01990911
Renal Sympathetic Denervation Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study
A study testing Renal denervation and Medical therapy in people with Hypertension and Hypertensive Heart Disease, run by Pace Clinic at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hypertension, Hypertensive Heart Disease, Atrial Fibrillation
- What is being tested?
- Renal denervation and Medical therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2013to 6 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Renal Sympathetic Denervation Restores Autonomic Imbalance and 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.
Read the 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.
- Being tested
- Renal denervation, Medical therapy
- Keywords
- hypertension, hypertensive heart disease, atrial fibrillation, autonomic imbalance
- Medical subject headings
- Hypertension, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationDevice
Also called Symplicity catheter 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.
Medical therapyDrug
Also called Three or more blood pressure tablets, including a diuretic
Subjects will continue on their standard medical therapy as prescribed by their treating physician
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Renal denervation; Drug: Medical therapy |
| Medical therapy | Sham comparator | This group will not receive renal sympathetic denervation Receives: Drug: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 years
Secondary outcomes (1)
Restoration of autonomic imbalance
Restoration of autonomic imbalance: lowering resting heart rate, prolonging the PR-interval and improving heart rate recovery after exercise.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMar 2013
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pace Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Saarland
- Responsible party
- Principal investigator, Marshall Jacobus Heradien, Pace Clinic
- Investigators
- Paul A Brink, PhD, Study director, Tygerberg Hospital and Stellenbosch UniversityMichael Bohm, PhD, Study director, University Hospital, Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990911
- Sponsor's protocol ID
- RDPAF1
- Acronym
- RDPAF
- Status last verified
- Sep 2022
- First submitted
- 9 Nov 2013
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35781044
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Sympathetic Denervation Restores Autonomic Imbalance and Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT01990911
- Acronym / sponsor ID
- RDPAF / RDPAF1
- Keywords
- hypertension, hypertensive heart disease, atrial fibrillation, autonomic imbalance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pace ClinicUniversity, hospital or other
- Collaborators
- University Hospital, Saarland
- Study start
- Mar 2013 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal denervation | Experimental | Device: Renal denervation, Drug: Medical therapyRenal 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. |
| Medical therapy | Sham comparator | Drug: Medical therapyThis group will not receive renal sympathetic denervation |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal denervationAlso: Symplicity catheter renal denervationIn 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. | Device | Renal denervation |
| Medical therapyAlso: Three or more blood pressure tablets, including a diureticSubjects will continue on their standard medical therapy as prescribed by their treating physician | Drug | Medical therapy, Renal denervation |
Primary outcome
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).
1 secondary outcome
Restoration of autonomic imbalance
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Background: PubMed 35781044Heradien 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A Brink, PhD study director
Tygerberg Hospital and Stellenbosch University
Michael Bohm, PhD study director
University Hospital, Saarland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation and Medical therapy in people with Hypertension and Hypertensive Heart Disease, run by Pace Clinic at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.