heartfailure high blood pressure
Conditions
Interventions
Renal denervation
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Individual is diagnosed with heart failure with a normal LV ejection fraction. The diagnosis of HFNEF requires the following conditions to be satisfied (see also figure 1 and Appendix A): a. signs or symptoms of heart failure; b. normal or mildly abnormal systolic LV function (LVEF * 50%); c. evidence of diastolic LV dysfunction.;Individual is adhering to a stable drug regimen including at least 2 antihypertensive drugs (with no changes for a minimum of 2 weeks prior to enrolment) which is expected to be maintained for at least 6 months. Using this regimen the blood pressure should be adequately controlled (
Exclusion criteria
Exclusion criteria: Individual is known with myocardial infarction as a cause of heart failure with normal LV ejection fraction. ;Individual has renal artery anatomy that is ineligible for treatment including: a.Main renal arteries
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the efficacy of RDN as a treatment modality for heart failure with a normal LV ejection fraction. Echocardiographic endpoints: *The change in the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E') (E/E*), determined by pulsed wave Doppler. *The change in duration of reversed pulmonary vein arterial systolic flow (Ard) minus the duration of the mitral valve atrial wave flow (Ad) (Ard-Ad), determined by pulsed wave Doppler. These changes will be expressed in milliseconds. *The change in left atrial volume index (LA volume indexed for body surface area), determined by pulsed wave Doppler. These changes will be expressed in millilitres per square meter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological endpoints: *The change in LV wall thickness/ LV mass, - determined by balanced SSFP cine MRI * after RD. These dimensions include LV-mass. This change will be expressed in grams and grams per square meter of body surface area. *The change in LV-volume and LA-volume * determined by MRI. These changes will be expressed in millilitres per square meter of body surface. *The change in LVEF * determined by MRI. This change will be expressed in percentage. *The change in MIBG-uptake and -washout. This will be determined by MIBG. Laboratorial endpoints: *The effect of RDN on absolute changes of B-Natriuretic Peptide. Blood pressure related endpoints: *The effect on blood pressure reduction, this will be measured in absolute changes, comparing changes after RDN with baseline SBP and DBP. Hereby also taking into account the home blood pressure measurements. Clinical endpoints: *The effect of QoL will be measured by the Minnesota Living with Heart Failure Questionnaire. *The effect of RDN on the exercise capacity will be assessed by the 6-minute walking test. | — |
Countries
Netherlands
Outcome results
None listed