Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01990911
Other study ID # RDPAF1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date June 6, 2022

Study information

Verified date September 2022
Source Pace Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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 RevealĀ® 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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 6, 2022
Est. primary completion date June 6, 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Intervention

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.
Drug:
Medical therapy
Subjects will continue on their standard medical therapy as prescribed by their treating physician

Locations

Country Name City State
South Africa Pace Clinic Cape Town Western Cape

Sponsors (2)

Lead Sponsor Collaborator
Pace Clinic University Hospital, Saarland

Country where clinical trial is conducted

South Africa, 

References & 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, Böhm M, Brink PA. Renal denervation prevents subclinical atrial fibrillation in patients with hypertensive heart disease: Randomized, sham-controlled trial. Heart Rhythm. 2022 Jun 30. pii: S1547-5271(22)02160-9. doi: 10.1016/j.hrthm.2022.06.031. [Epub ahead of print] — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 (RevealĀ® holter). 3 years
Secondary Restoration of autonomic imbalance Restoration of autonomic imbalance: lowering resting heart rate, prolonging the PR-interval and improving heart rate recovery after exercise. 3 years
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A