Denervation of the renal sympathetic nerves in heart failure with normal LV ejection fraction.

Phase 2

Completed

• Conditions: 10019280; heartfailure; high blood pressure; 10057166

• Registration Number: NL-OMON39827
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-07-07
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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 (<140/90mmHg by 24 hour ambulatory BP measurement).;Individual is *18 years of age.;Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

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 < 4 mm in diameter or < 20 mm in length.
b.Hemodynamically or anatomically significant renal artery abnormality or stenosis in either renal artery which, in the eyes of the operator, would interfere with safe cannulation of the renal artery or meets standards for surgical repair or interventional dilation.
c.A history of prior renal artery stenting.
d.Multiple main renal arteries in either kidney.;Individual has an estimated glomerular filtration rate (eGFR) of <30mL/min/1.73m2, using the MDRD calculation.;Individual is known with any secondary cause of hypertension.;Individual is known with any other cause of respiratory dysfunction that explains the presenting signs and symptoms. Patients with COPD Gold I-II and evident heart failure (see appendix A) will be eligible for inclusion. ;Individual has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of the screening visit, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques.;Individual has scheduled or planned surgery or cardiovascular intervention in the next 6 months.;Individual has hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous.;Individual has an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot allow for RF energy delivery.;Individual has any serious medical condition, which in the opinion of the investigator, may adversely affect the safety and/or effectiveness of the participant or the study (i.e., patients with clinically significant peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, haemophilia, or significant anaemia, or cardiac arrhythmias).;Individual is pregnant, nursing or planning to be pregnant. ;Individual has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable to comply with study follow-up requirements.;Individual is currently enrolled in another investigational drug or device trial.;Individual is currently being treated with any of the following medications:
a.Drugs that cause salt retention (e.g., systemic corticosteroids and fludrocortisone)
b.Warfarin or phenprocoumon that cannot be temporarily stopped for the procedure.;Any contraindications for MRI:
a.The presence of implanted cardiac pacemakers and/or auto-implanted cardioverter defibrillators.
b.Mechanical cardiac valves.
c.Implanted electronic devices like cochlear implants and nerve stimulators.
d.Patients who are unable to fit into the bore of the magnet.
e.Claustrophobia.
f.Prosthesis of a joint

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To study the efficacy of RDN as a treatment modality for heart failure with a<br /><br>normal LV ejection fraction.<br /><br>Echocardiographic endpoints:<br /><br>*The change in the ratio of mitral peak velocity of early filling (E) to early<br /><br>diastolic mitral annular velocity (E') (E/E*), determined by pulsed wave<br /><br>Doppler.<br /><br>*The change in duration of reversed pulmonary vein arterial systolic flow (Ard)<br /><br>minus the duration of the mitral valve atrial wave flow (Ad) (Ard-Ad),<br /><br>determined by pulsed wave Doppler. These changes will be expressed in<br /><br>milliseconds.<br /><br>*The change in left atrial volume index (LA volume indexed for body surface<br /><br>area), determined by pulsed wave Doppler. These changes will be expressed in<br /><br>millilitres per square meter.</p><br>