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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by UMC Utrecht
Sponsor:
Collaborator:
VU University of Amsterdam
Information provided by (Responsible Party):
Michiel Voskuil, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01583881
First received: April 19, 2012
Last updated: April 23, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Diastolic Heart Failure
Hypertension
Procedure: renal denervation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sympathetic Renal Denervation in Heart Failure With Normal LV Ejection Fraction: Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Change from baseline E/E' at 12 months [ Time Frame: 12 months after treatment ] [ Designated as safety issue: No ]
    Echocardiography will be used to measure the E/E'


Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Renal denervation
Renal denervation
Procedure: renal denervation
Renal denervation
No Intervention: control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01583881

Contacts
Contact: Willemien Verloop, MD 0031887559447 w.l.verloop@umcutrecht.nl
Contact: Michiel Voskuil, MD, PhD

Locations
Netherlands
VUmc Recruiting
Amsterdam, Netherlands
Contact: Cor Allaart, MD, PhD       cp.allaart@vumc.nl   
UMC Utrecht Recruiting
Utrecht, Netherlands
Contact: Willemien Verloop, MD       w.l.verloop@umcutrecht.nl   
Contact: Voskuil, MD, PhD       m.voskuil@umcutrecht.nl   
Sponsors and Collaborators
UMC Utrecht
VU University of Amsterdam
Investigators
Principal Investigator: Michiel Voskuil, MD, PhD UMC Utrecht
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michiel Voskuil, MD, PhD, MD. PhD., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01583881     History of Changes
Other Study ID Numbers: 12-046
Study First Received: April 19, 2012
Last Updated: April 23, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Patients with diastolic heart failure and hypertension

Additional relevant MeSH terms:
Heart Failure
Hypertension
Heart Failure, Diastolic
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014