Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction

NCT01583881 | Terminated Phase 2

• 1 other identifier: 12-046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Increasing evidence suggests an important role of activation of the sympathetic nervous system (SNS) in the clinical phenomena of heart failure with normal left ventricular ejection fraction and hypertension. The current study aims to evaluate efficacy and safety of renal sympathetic denervation for the modulation of the SNS in patients with heart failure with normal LV ejection fraction.

Conditions

Diastolic Heart Failure; Hypertension

Keywords

Patients with diastolic heart failure and hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline E/E' at 12 months

  Echocardiography will be used to measure the E/E'

  12 months after treatment

Secondary Outcomes (1)

• Number of participants with adverse events

  1 year

Study Arms (2)

Renal denervation

EXPERIMENTAL

Renal denervation

Procedure: renal denervation

control

NO INTERVENTION

No intervention

Interventions

renal denervation PROCEDURE

Renal denervation

Renal denervation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual is diagnosed with heart failure with a normal LV ejection fraction. The diagnosis of HFNEF requires the following conditions to be satisfied:
• signs or symptoms of heart failure;
• normal or mildly abnormal systolic LV function (LVEF ≥ 50%);
• evidence of diastolic LV dysfunction.
• Individual should fulfill the diagnostic WHO criteria for hypertension: SBP \> 140 mmHg and/or DBP \> 90 mmHg, and is treated with at least 2 antihypertensive drugs. This treatment 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 adhering to a stable drug regimen HFNEF, with no changes for a minimum of 2 weeks prior to enrollment, and which is expected to be maintained for at least 6 months.
• Individual is ≥ 18 years of age.

You may not qualify if:

• Known secondary cause of hypertension
• Anatomy not eligible for renal denervation
• Systolic heart failure (LVEF \< 50%)
• Individual has an estimated glomerular filtration rate (eGFR) of \< 30mL/min/1.73m2, using the MDRD calculation.
• 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, significant anaemia, or arrhythmias such as atrial fibrillation).
• Individual is pregnant, nursing or planning to be pregnant.

Sponsors & Collaborators

• UMC Utrecht: lead
• VU University of Amsterdam: collaborator

Study Sites (2)

VUmc

Amsterdam, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Publications (1)

• Verloop WL, Beeftink MM, Nap A, Bots ML, Velthuis BK, Appelman YE, Cramer MJ, Agema WR, Scholtens AM, Doevendans PA, Allaart CP, Voskuil M. Renal denervation in heart failure with normal left ventricular ejection fraction. Rationale and design of the DIASTOLE (DenervatIon of the renAl Sympathetic nerves in hearT failure with nOrmal Lv Ejection fraction) trial. Eur J Heart Fail. 2013 Dec;15(12):1429-37. doi: 10.1093/eurjhf/hft119. Epub 2013 Jul 24.

  PMID: 23883653 DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic; Hypertension

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Michiel Voskuil, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

NL (2)