Chronic Heart FailureRE-ADAPT-HFNCT04947670
A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure
A study testing Renal arteriography followed by renal denervation in people with Chronic Heart Failure and Cardio-Renal Syndrome, run by Universität des Saarlandes at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure, Cardio-Renal Syndrome
- What is being tested?
- Renal arteriography followed by renal denervation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteGermany
- Study dates
- 13 Jun 2022to 6 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Saarland University Medical Center, Department for Internal Medicine III
Homburg/Saar, Saarland, 66421
About this study
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.
Read more
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.
- Conditions
- Chronic Heart Failure, Cardio-Renal Syndrome
- Being tested
- Renal arteriography followed by renal denervation, Sham Renal arteriography
- Medical subject headings
- Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal arteriography followed by renal denervationProcedure or surgery
Renal arteriography followed by renal denervation
Sham Renal arteriographyProcedure or surgery
Renal arteriography only
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Renal denervation and maintenance of heart failure medications Receives: Procedure: Renal arteriography followed by renal denervation |
| Control Group | Sham comparator | Sham intervention, maintenance of heart failure medications with option for cross-over renal denervation treatment after 12 months Receives: Procedure: Sham Renal arteriography |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
Change in 6-min walk distance
Measured: 6 months
Secondary outcomes (4)
NT-proBNP
Change in plasma NT-proBNP values
Measured: 6 months
KCCQ
Change in Overall Summary Score measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: 6 months
EQ-5D
Change in Chronic Heart Failure Questionnaire Self-Administered Standardized format (CHQ-SAS) dyspnea score
Measured: 6 months
eGFR
chronic eGFR slope defined as eCRF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start13 Jun 2022
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Collaborators
- Interdisciplinary Center Clinical Trials (IZKS), University Medical Center Mainz
- Responsible party
- Sponsor
- Investigators
- Felix Mahfoud, MD, Principal investigator, Saarland University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04947670
- Sponsor's protocol ID
- RE-ADAPT-HF (2021)
- Acronym
- RE-ADAPT-HF
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2021
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Blinded, Sham-controlled, Feasibility Study of Renal Denervation in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT04947670
- Acronym / sponsor ID
- RE-ADAPT-HF / RE-ADAPT-HF (2021)
- Conditions
- Chronic Heart Failure, Cardio-Renal Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Collaborators
- Interdisciplinary Center Clinical Trials (IZKS), University Medical Center Mainz
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Renal arteriography followed by renal denervationRenal denervation and maintenance of heart failure medications |
| Control Group | Sham comparator | Procedure: Sham Renal arteriographySham intervention, maintenance of heart failure medications with option for cross-over renal denervation treatment after 12 months |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal arteriography followed by renal denervationRenal arteriography followed by renal denervation | Procedure or surgery | Treatment Group |
| Sham Renal arteriographyRenal arteriography only | Procedure or surgery | Control Group |
Primary outcome
6 Minute Walk Test
Time frame: 6 months
Change in 6-min walk distance
4 secondary outcomes
NT-proBNP
Time frame: 6 months
KCCQ
Time frame: 6 months
EQ-5D
Time frame: 6 months
eGFR
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix Mahfoud, MD principal investigator
Saarland University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal arteriography followed by renal denervation in people with Chronic Heart Failure and Cardio-Renal Syndrome, run by Universität des Saarlandes at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.