None listed
Conditions
Brief summary
Amongst the attributable factors, hypertension is the predominant risk leading to atrial fibrillation (AF) and premature cardiovascular events. As compare to brachial blood pressure, central blood pressure and aortic stiffness assessment even in “normotensives”, has shown improve predictability of cardiovascular outcomes including atrial fibrillation. Cardiovascular risk stratification based on central blood pressure indices can be more relevant as it demonstrates the central pulsatile load an organ is exposed to and reveals early vascular remodelling of central arterial tree resulting in aortic stiffness. Non-invasively derived central hemodynamic indices have been demonstrated to predict cardiovascular outcomes in a variety of settings. We propose a single blinded, randomised prospective trial to risk profile our AF patients according to their non-invasive assessment of peripheral or central blood pressure including aortic stiffness estimate. The impact of central or peripheral blood pressure treatment , on AF outcomes will be analysed. In addition, the relationship between central or peripheral high blood pressure and non-invasive indicators of end organ (cardiac, vascular, renal and retinal) injury will be explored.
Interventions
The interventional arm will get treated as per their non-invasive central (aortic) blood pressure targets as per established reference values (European Heart Journal, Volume 35, Issue 44, 21 November 2014, Pages 3122–3133, https://doi.org/10.1093/eurheartj/ehu293) with the appropriate anti-HTN (ACE-I/ARBs, Ca Channel blockers and diuretics as first line therapy as per AHA 2017 guidelines ). The therapy will be titrated as per blood pressure response during three monthly follow ups for next 2 yea
The interventional arm will get treated as per their non-invasive central (aortic) blood pressure targets as per established reference values (European Heart Journal, Volume 35, Issue 44, 21 November 2014, Pages 3122–3133, https://doi.org/10.1093/eurheartj/ehu293) with the appropriate anti-HTN (ACE-I/ARBs, Ca Channel blockers and diuretics as first line therapy as per AHA 2017 guidelines ). The therapy will be titrated as per blood pressure response during three monthly follow ups for next 2 years post recruitment. The impact of central blood pressure treatment on AF and cardiovascular outcomes will be studied. During the three monthly follow ups side effects of the medications including postural hypotension and affect on renal function will be recorded. The anti-HTN treatment will be gradually titrated as per symptoms and target BP goals. The treatment target for non-invasive central systolic pressure will be as follows: (Int. J Angiol.2010 Winter; 19(4):e132-e134) Age (yrs.) Range (mmHg) Average (mmHg) 20-30 90-112 101 30-40 94-116 105 40-50 97-119 108 50-60 101-123 112 60-70 104-126 115 70-80 108-130 119 80-90 111-133 122 The impact of central blood pressure control will be compared with control group re AF and CV outcomes.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patient with known AF Age (18-80yrs.) Non- Pregnant
Exclusion criteria
1. Age <18years 2. Contraindications to exercise stress test (EST) 3. Pregnancy 4. Active malignancy or severe illness 5. Active Inflammatory disorder 6. Severe Aortopathy 7. Advanced valvular heart disease including aortic insufficiency (AI) 8. Constrictive or restrictive cardiomyopathy 9. Contraindications to non-contrast CMR (in selected patients scheduled for PVI)
Outcome results
None listed