Renal Denervation in Heart Failure

Phase 2

Recruiting

• Conditions: Heart Failure; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12615000203550
• Lead Sponsor: Dr Suku Thambar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Able to comprehend requirements and provide consent.
2. Males or females greater than or equal to 18years.
3. Established congestive heart failure with NYHA Class II-III
4. Left Ventricular Ejection Fraction (LVEF) less than or equal to 35% on echocardiography.
5. Adequate renal function with estimated GFR greater than or equal to 30 mL/min.
6. Optimal stable medical therapy for heart failure for at
least 3 months prior to study entry as per ACCF/AHA
guidelines.

Exclusion Criteria

1. Renal artery abnormalities (i.e. too small, presence of significant stenosis, prior angioplasty procedure, multiple main renal arteries).
2. Single functioning kidney.
3. End Stage Renal Disease requiring haemo-dialysis or
renal transplant.
4. Unstable vascular syndromes, such as myocardial
infarction, unstable angina pectoris or cerebro-vascular
accident, within 3 months.
5. Systolic blood pressure less than 100mmHg.
6. Haemodynamically significant valvular heart disease.
7. Pregnant, nursing or planning on becoming pregnant
during the course of the study.
8. Enrolled in, or intend to participate in, another
investigational drug or device trial.
9. Any concurrent disease or condition that, in the opinion
of the investigator, would make the subject unsuitable
for participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified