Renal Denervation in Patients With Chronic Heart Failure

NCT02085668 | Withdrawn DMC

• 2 other identifiers: RE-ADAPT-HFCIV-13-10-011660
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 11

Brief Summary

The purpose of the trial is to investigate the safety and effectiveness of renal denervation for the treatment of chronic heart failure (CHF).

Conditions

Chronic Heart Failure; Cardio-Renal Syndrome

Keywords

Chronic Heart Failure; Cardio-Renal Syndrome; Renal Denervation; Symplicity; Sympathetic activation

Outcome Measures

Primary Outcomes (1)

• Safety of renal denervation with the Symplicity Catheter System with special consideration of clinically significant periprocedural adverse events in CHF patients

  Number of complications associated with the delivery and/or use of the Symplicity Catheter (e.g., vascular injury and bleeding complications, access site hematoma, etc.). Vital signs, blood and urine measurements taken before, during and after the denervation procedure

  Baseline visit for treatment group, month 6 visit for control group

Secondary Outcomes (4)

• Physiologic response to renal denervation: ventricular function

  From denervation prodecure to 6 months after renal denervation procedure

• Physiologic Response to renal denervation: renal function

  From denervation prodecure to 6 months after renal denervation procedure

• Physiologic Response to renal denervation: symptomatology/Quality of Life

  From denervation prodecure to 6 months after renal denervation procedure

• Physiologic Response to renal denervation: additional parameters

  From denervation prodecure to 6 months after renal denervation procedure

Study Arms (2)

Treatment Group

EXPERIMENTAL

Renal denervation and maintenance of heart failure medications

Device: Renal denervation (Symplicity™)

Control Group

NO INTERVENTION

Maintenance of heart failure medications with option for cross-over renal denervation treatment after 6-months

Interventions

Renal denervation (Symplicity™) DEVICE

Delivery of radiofrequency through the wall of the renal artery to disrupt the surrounding renal nerves under angiography control

Also known as: Renal denervation with Symplicity™ Renal Denervation System

Treatment Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New York Heart Association Class II-III symptoms of chronic heart failure
• Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction in a range of 10%- 40%.
• GFR \>30 mL/min/1.73m2
• Brain natriuretic Peptide (BNP) \>100 pg/ml or N terminal (NT)-Pro-BNP \>400 pg/ml.
• Optimal medical therapy according to current guidelines for CHF management. Treatment for HF must be stable (including drug and dose) for at least 4 weeks prior to procedure, with the exception of diuretics, where stability is required for at least 2 weeks.
• others

You may not qualify if:

• Renal arterial anatomy that is ineligible for treatment
• CHF caused by pericarditis or by acute myocarditis or by endocrine diseases.
• Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within three 12 weeks of the screening visit.
• Office systolic BP at screening less than 90 mmHg
• Primary pulmonary hypertension.
• Clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
• Major surgery, including bariatric surgery, in the previous 12 weeks before baseline.
• Contrast media administration in the previous 30 days before baseline.
• Known hypersensitivity to material of the Symplicity Catheter.
• Inpatient hospitalization for decompensated HF in the previous 60 days before baseline.
• others

Sponsors & Collaborators

• University Hospital, Saarland: lead

Study Sites (11)

Paracelsus Medical University

Salzburg, 5020, Austria

Location

University Heart Center Freiburg Bad Krozingen

Bad Krozingen, 79189, Germany

Location

German Heart Institute Berlin

Berlin, 13353, Germany

Location

University Hospital Bonn

Bonn, 53127, Germany

Location

University Hospital Gießen Marburg

Giessen, 35392, Germany

Location

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

University Hospital Saarland

Homburg/Saar, 66421, Germany

Location

University of Leipzig, Heart Center

Leipzig, 04289, Germany

Location

University Hospital Tübingen

Tübingen, 72076, Germany

Location

Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Cardio-Renal Syndrome

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Böhm, MD

  University Hospital, Saarland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 13, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2019
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

DE (8); AU (1); SE (1); CH (1)