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NCT01583881: DIASTOLE
Denervation of the renAl sympathetIc nerveS in hearT Failure With nOrmal Lv Ejection Fraction
Phase 2, PHASE3 trial testing renal denervation in Diastolic Heart Failure in 60 participants. Terminated before completion.
1 June 2016
Quick facts
| Lead sponsor | UMC Utrecht |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 1 April 2012 |
| Primary completion | 1 June 2016 |
| Estimated completion | 1 July 2016 |
| Sites | 2 locations across Netherlands |
Drugs / interventions tested
- renal denervation
Conditions studied
- Diastolic Heart Failure — all drugs for Diastolic Heart Failure →
- Hypertension — all drugs for Hypertension →
Sponsor
UMC Utrecht — full company profile →
Who can join
18 and older, any sex, with Diastolic Heart Failure or Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Renal denervation in heart failure with normal left ventricular ejection fraction. Rationale and design of the DIASTOLE (DenervatIon of the renAl Sympathetic nerves in hearT failure with nOrmal Lv Ejection fraction) trial.
Verloop WL, Beeftink MM, Nap A, Bots ML, et al · · 2013 · cited 34× · PMID 23883653 · DOI 10.1093/eurjhf/hft119 -
Autonomic nervous system and cardiac neuro-signaling pathway modulation in cardiovascular disorders and Alzheimer's disease.
Elia A, Fossati S. · · 2023 · cited 29× · PMID 36798942 · DOI 10.3389/fphys.2023.1060666 -
Renal denervation for resistant hypertension.
Coppolino G, Pisano A, Rivoli L, Bolignano D. · · 2017 · cited 22× · PMID 28220472 · DOI 10.1002/14651858.cd011499.pub2 -
Renal denervation for resistant hypertension.
Pisano A, Iannone LF, Leo A, Russo E, et al · · 2021 · cited 14× · PMID 34806762 · DOI 10.1002/14651858.cd011499.pub3 -
Renal denervation beyond the bifurcation: The effect of distal ablation placement on safety and blood pressure.
Beeftink MM, Spiering W, De Jong MR, Doevendans PA, et al · · 2017 · cited 8× · PMID 28296025 · DOI 10.1111/jch.12989 -
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 -
Device-Based Sympathetic Nerve Regulation for Cardiovascular Diseases.
Li L, Hu Z, Xiong Y, Yao Y. · · 2021 · cited 4× · PMID 34957267 · DOI 10.3389/fcvm.2021.803984 -
Reconsidering Renal Sympathetic Denervation for Heart Failure.
Tang WHW, Dunlap ME. · · 2017 · cited 2× · PMID 30062149 · DOI 10.1016/j.jacbts.2017.05.003
Verify or expand the search:
- PubMed search for NCT01583881
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
Other trials of renal denervation
Trials testing the same drug.
- NCT07320768 — Renal Denervation Combined With Pulsed Field Ablation to Prevent Blanking-Period Recurrence in Persistent Atrial Fibrill · NA · not yet recruiting
- NCT06556407 — Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis · NA · recruiting
- NCT04182620 — Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation Ablation · NA · completed
Other recruiting trials for Diastolic Heart Failure
Currently open trials in the same condition.
- NCT05408559 — Prevention of Age-associated Cardiac and Vascular Dysfunction Using Avmacol ES · Phase 1, PHASE2 · recruiting
- NCT05064709 — Assessment of CCM in HF With Higher Ejection Fraction · NA · recruiting
- NCT04160000 — Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure · Phase 4 · recruiting
Other UMC Utrecht trials
Trials by the same sponsor.
- NCT07512336 — A Randomized Intra-Patient Controlled Trial of MagnetOs™ Putty vs Autograft in Instrumented Posterolateral Spinal Fusion · NA · not yet recruiting
- NCT07485985 — Coronary Sinus Reducer Therapy for Persisting Angina · NA · not yet recruiting
- NCT07449052 — Comprehensive Invasive Physiological Evaluation of Obstructive Coronary Artery Disease · NA · not yet recruiting
- NCT05375708 — Systemic Therapy in Combination with Stereotactic Radiotherapy in Patients with Metastatic Colorectal Cancer Up to 10 Me · Phase 2 · suspended
- NCT06898541 — Coronary Sinus Reducer in Coronary Microvascular Disease · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01583881 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UMC Utrecht
- Last refreshed: 3 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01583881.
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