Hypertension Clinical Trial
— RDPAFOfficial title:
Renal Sympathetic Denervation Restores Autonomic Imbalance and Prevents Atrial Fibrillation in Patients With Hypertensive Heart Disease: a Pilot Study
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 |
Verified date | September 2022 |
Source | Pace Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
South Africa | Pace Clinic | Cape Town | Western Cape |
Lead Sponsor | Collaborator |
---|---|
Pace Clinic | University Hospital, Saarland |
South Africa,
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
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 |
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