Back to results

A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure (RE-ADAPT-HF)

Primary Purpose

Chronic Heart Failure, Cardio-Renal Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Renal arteriography followed by renal denervation

Sham Renal arteriography

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient with CHF diagnosed for at least 3 months prior to consent
6-min walk distance ≤350 m
NYHA Class II-III symptoms of CHF
Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction <45%
eGFR calculated (CKD-EPI) >30 ml/min/1.73 m2
NT-pro-BNP >450 pg/ml, >900 pg/ml for patients with atrial fibrillation
Optimal medical drug therapy according to current guidelines for CHF management. This medication may include loop diuretics, ACEi/ARBs, ARNI, SGLT-2 inhibitors, aldosterone antagonists, and beta-blockers, unless intolerance to any of the above is documented. Treatment for HF must be stable (including drug and dose) for 4 weeks prior to randomization, except diuretics (2 weeks stable)
Appropriate use of medical devices such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international guidelines, and if a device is required, it must have been implanted for at least 3 months prior to consent for CRT and 1 month prior to consent for ICD
Age ≥18 years and ≤80 years

Exclusion Criteria:

Renal arterial anatomy that is ineligible for treatment
Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 12 weeks prior to consent
Office systolic BP at screening <90 mmHg
Clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve
Hypertrophic obstructive cardiomyopathy
Major surgery in the previous 12 weeks prior to consent
Hospitalization for decompensated CHF in the <30 days prior to consent
Parenteral therapy for the treatment of CHF
Respiratory support (excluding sleep apnea therapy)
Left ventricular assist or planned heart transplantation
Patient is pregnant, nursing, or planning to be pregnant
Ineligibility to consent
Primary pulmonary hypertension (systolic PAP >70 mmHg)
BMI ≥40 kg/m²
Any condition that would contraindicate the assessment of 6-min walk distance.
Patient has type I diabetes mellitus

Sites / Locations

Saarland University Medical Center, Department for Internal Medicine IIIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment Group

Control Group

Arm Description

Renal denervation and maintenance of heart failure medications

Sham intervention, maintenance of heart failure medications with option for cross-over renal denervation treatment after 12 months

Outcomes

Primary Outcome Measures

6 Minute Walk Test

Change in 6-min walk distance

Secondary Outcome Measures

NT-proBNP

Change in plasma NT-proBNP values

KCCQ

Change in Overall Summary Score measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

EQ-5D

Change in Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnea score

eGFR

chronic eGFR slope defined as eCRF

Full Information

NCT ID

NCT04947670

First Posted

June 24, 2021

Last Updated

November 3, 2022

Sponsor

Universität des Saarlandes

Collaborators

Interdisciplinary Center Clinical Trials (IZKS), University Medical Center Mainz

1. Study Identification

Unique Protocol Identification Number

NCT04947670

Brief Title

A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure

Acronym

RE-ADAPT-HF

Official Title

A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 13, 2022 (Actual)

Primary Completion Date

May 1, 2025 (Anticipated)

Study Completion Date

May 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universität des Saarlandes

Collaborators

Interdisciplinary Center Clinical Trials (IZKS), University Medical Center Mainz

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The renin-angiotensin-aldosterone axis has been found to be a key system involved in heart failure disease progression and it may be inhibited by renal sympathetic denervation. Therefore, a clear need exists for further strategies to beneficially manipulate the sympathetic activation that is characteristic of the heart failure disease process. The combined experience in the pilot studies and the EU randomized, controlled study indicates that the Paradise Catheter System can safely denervate renal sympathetic nerves of the kidney without significant periprocedural complications. Preliminary results of a pilot study of catheter-based renal denervation in a small number of CHF patients did not show evidence of safety issues but suggest improvements in CHF symptoms. This trial will explore the safety and feasibility of renal denervation in a significantly higher number of patients with chronic heart failure. Both inter-individual and intra-individual controls will be used in order to obtain sufficient data and to in order to enable both treatment and control group to receive renal denervation. Additionally, this feasibility trial to describe the safety and feasibility of renal denervation in patients with elevated sympathetic activity as in patients with chronic heart failure, will further the understanding of the role of renal nerves in the control of chronic heart failure and the pathogenesis of both ventricular remodeling and cardio-renal syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure, Cardio-Renal Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Prospective, randomized, double-blind, sham-controlled, multicenter, feasibility study. Patients will be screened for meeting eligibility and centrally randomized to receive either renal denervation or sham procedure. Best medical therapy will be provided to all patients. Optional cross-over after 12 months for sham-group patients. Thus, there is an intra-individual control in patients of the control group and all of the randomized patients are entitled to receive study treatment.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Unblinded interventionist, unblinded intervention team and blinded study team at each center, blinded patient.

Allocation

Randomized

Enrollment

144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Renal denervation and maintenance of heart failure medications

Arm Title

Control Group

Arm Type

Sham Comparator

Arm Description

Sham intervention, maintenance of heart failure medications with option for cross-over renal denervation treatment after 12 months

Intervention Type

Procedure

Intervention Name(s)

Renal arteriography followed by renal denervation

Intervention Description

Renal arteriography followed by renal denervation

Intervention Type

Procedure

Intervention Name(s)

Sham Renal arteriography

Intervention Description

Renal arteriography only

Primary Outcome Measure Information:

Title

6 Minute Walk Test

Description

Change in 6-min walk distance

Time Frame

6 months

Secondary Outcome Measure Information:

Title

NT-proBNP

Description

Change in plasma NT-proBNP values

Time Frame

6 months

Title

KCCQ

Description

Change in Overall Summary Score measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time Frame

6 months

Title

EQ-5D

Description

Change in Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnea score

Time Frame

6 months

Title

eGFR

Description

chronic eGFR slope defined as eCRF

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient with CHF diagnosed for at least 3 months prior to consent 6-min walk distance ≤350 m NYHA Class II-III symptoms of CHF Systolic left ventricular dysfunction as assessed by echocardiogram with left ventricular ejection fraction <45% eGFR calculated (CKD-EPI) >30 ml/min/1.73 m2 NT-pro-BNP >450 pg/ml, >900 pg/ml for patients with atrial fibrillation Optimal medical drug therapy according to current guidelines for CHF management. This medication may include loop diuretics, ACEi/ARBs, ARNI, SGLT-2 inhibitors, aldosterone antagonists, and beta-blockers, unless intolerance to any of the above is documented. Treatment for HF must be stable (including drug and dose) for 4 weeks prior to randomization, except diuretics (2 weeks stable) Appropriate use of medical devices such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy (CRT) consistent with prevailing local or international guidelines, and if a device is required, it must have been implanted for at least 3 months prior to consent for CRT and 1 month prior to consent for ICD Age ≥18 years and ≤80 years Exclusion Criteria: Renal arterial anatomy that is ineligible for treatment Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 12 weeks prior to consent Office systolic BP at screening <90 mmHg Clinically significant cardiac structural valvular disease, unless corrected by a properly functional prosthetic valve Hypertrophic obstructive cardiomyopathy Major surgery in the previous 12 weeks prior to consent Hospitalization for decompensated CHF in the <30 days prior to consent Parenteral therapy for the treatment of CHF Respiratory support (excluding sleep apnea therapy) Left ventricular assist or planned heart transplantation Patient is pregnant, nursing, or planning to be pregnant Ineligibility to consent Primary pulmonary hypertension (systolic PAP >70 mmHg) BMI ≥40 kg/m² Any condition that would contraindicate the assessment of 6-min walk distance. Patient has type I diabetes mellitus

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Felix Mahfoud, MD

Phone

+49-6841-16-15911

Felix.Mahfoud@uks.eu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Felix Mahfoud, MD

Organizational Affiliation

Saarland University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saarland University Medical Center, Department for Internal Medicine III

City

Homburg/Saar

State/Province

Saarland

ZIP/Postal Code

66421

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Felix Mahfoud, MD

Phone

+49-6841-16-15911

Felix.Mahfoud@uks.eu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure

We'll reach out to this number within 24 hrs