NCT04947670: RE-ADAPT-HF

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

Terminated NA Last updated 2 December 2025

What this trial tests

NA trial testing Renal arteriography followed by renal denervation in Chronic Heart Failure in 4 participants. Terminated before completion.

Timeline

13 June 2022

Primary endpoint
6 September 2024

6 September 2024

Quick facts

Lead sponsor	Universität des Saarlandes
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	4
Start date	13 June 2022
Primary completion	6 September 2024
Estimated completion	6 September 2024
Sites	1 location across Germany

Drugs / interventions tested

• Renal arteriography followed by renal denervation
• Sham Renal arteriography

Conditions studied

• Chronic Heart Failure — all drugs for Chronic Heart Failure →
• Cardio-Renal Syndrome — all drugs for Cardio-Renal Syndrome →

Sponsor

Universität des Saarlandes — full company profile →

Who can join

Adults 18 to 80, any sex, with Chronic Heart Failure or Cardio-Renal Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Autonomic Nervous System: A Therapeutic Target for Cardiac End-Organ Damage in Hypertension.
   Gottlieb LA, Mahfoud F, Stavrakis S, Jespersen T, et al · · 2024 · cited 8× · PMID 39136127 · DOI 10.1161/hypertensionaha.123.19460
2. Renal Denervation in Heart Failure Treatment: Data for a Self-Fulfilling Prophecy.
   Dimitriadis K, Iliakis P, Pyrpyris N, Tatakis F, et al · · 2024 · cited 5× · PMID 39597800 · DOI 10.3390/jcm13226656
3. Neuromodulation Therapies in Heart Failure: A State-of-the-Art Review.
   Pahuja M, Akhtar KH, Krishan S, Nasir YM, et al · · 2023 · cited 5× · PMID 39131073 · DOI 10.1016/j.jscai.2023.101199
4. Renal denervation in the setting of heart failure.
   Koppe-Schmeißer F, Fengler K, Kresoja KP, Lurz P, et al · · 2025 · cited 4× · PMID 39875629 · DOI 10.1007/s10741-025-10489-z
5. Clinical research progress of renal denervation for heart failure treatment: current evidence, controversies, and future directions.
   Zhang D, Wang D, Wang X, Yu J, et al · · 2026 · PMID 41869525 · DOI 10.3389/fcvm.2026.1790873
6. Renal denervation revisited; should we pay attention?
   de Winter RJ. · · 2022 · PMID 35167039 · DOI 10.1007/s12471-022-01663-1