Renal Denervation in Heart Failure Patients With Preserved Ejection Fraction (RESPECT-HF)

Summary

Investigators will test a new approach to a form of heart failure (HF) with no current treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These "stiff" hearts pump strongly but fill inefficiently resulting in poor exercise capacity and high death rates. Treatments that help when heart pumping action is poor are of no benefit in HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the kidneys ("renal denervation"; RDN) has been able to reduce BP in patients with high BP resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys, heart and circulation this treatment has promise in HF. The investigators will compare effects of RDN and standard medical treatment on heart function, exercise capacity and quality of life in 144 patients with HFPEF

Conditions

• Heart Failure

Interventions

DEVICE

Renal Denervation

Sponsors & Collaborators

• University of Otago

  collaborator OTHER

• Wellington Hospital

  collaborator OTHER_GOV

• University of Auckland, New Zealand

  collaborator OTHER

• Monash University

  collaborator OTHER

• Tan Tock Seng Hospital

  collaborator OTHER

• Changi General Hospital

  collaborator OTHER

• Singapore Clinical Research Institute

  collaborator OTHER

• National University Hospital, Singapore

  lead OTHER

Principal Investigators

• Arthur Mark Richards, MBChB, MD (Distinction), PhD · University of Otago, Christchurch

• Henry Krum, MBBS, PhD, FRACP, FCSANZ · Monash University

• Carolyn Lam Su Ping, MBBS, MRCP, MS · National University Heart Centre, Singapore

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2015-12-31

Completion

2016-12-31

Countries

• Australia
• New Zealand
• Singapore

Study Locations