NCT03240237 (CCM-HFpEF) is a NA clinical trial of Optimizer SMART in Heart Failure, Diastolic, sponsored by Impulse Dynamics.

Who is sponsoring NCT03240237?

NCT03240237 is sponsored by Impulse Dynamics.

What drugs are being tested in NCT03240237?

Interventions in NCT03240237: Optimizer SMART.

What condition does NCT03240237 study?

NCT03240237 studies Heart Failure, Diastolic.

Is NCT03240237 still recruiting?

NCT03240237 is currently completed. Last updated 23 April 2024.

Last reviewed 2024-04-23 · How we verify

NCT03240237: CCM-HFpEF

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

CCM in Heart Failure With Preserved Ejection Fraction

Completed NA Last updated 23 April 2024

What this trial tests

NA trial testing Optimizer SMART in Heart Failure, Diastolic in 47 participants. Completed in 25 July 2023.

Timeline

1 May 2018

Primary endpoint
25 July 2023

25 July 2023

Quick facts

Lead sponsor	Impulse Dynamics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	47
Start date	1 May 2018
Primary completion	25 July 2023
Estimated completion	25 July 2023
Sites	17 locations across Italy, Sweden, Germany, Poland, Australia, Portugal, Spain, Czechia

Drugs / interventions tested

Optimizer SMART

Conditions studied

Heart Failure, Diastolic — all drugs for Heart Failure, Diastolic →

Sponsor

Impulse Dynamics — full company profile →

Who can join

Adults 40 to 80, any sex, with Heart Failure, Diastolic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or III symptoms despite appropriate medication. The terminology of the HF classification HFpEF is based on the 2016 European Society of Cardiology (ESC) Heart Failure Guidelines.

Publications & conference data

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

Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future.
Wintrich J, Kindermann I, Ukena C, Selejan S, et al · · 2020 · cited 76× · PMID 32236720 · DOI 10.1007/s00392-020-01633-w
Clinical effects of cardiac contractility modulation in heart failure with mildly reduced systolic function.
Tschöpe C, Butler J, Farmakis D, Morley D, et al · · 2020 · cited 13× · PMID 33274601 · DOI 10.1002/ehf2.13126
Advances in device-based treatment of heart failure with preserved ejection fraction: evidence from clinical trials.
Wu Y, Song M, Wu M, Lin L. · · 2024 · cited 9× · PMID 37986663 · DOI 10.1002/ehf2.14562
Nonpharmacological Approaches to Managing Heart Failure With Preserved Ejection Fraction.
Tang F, Han H, Fu S, Liu Q, et al · · 2024 · cited 3× · PMID 38887946 · DOI 10.1161/circheartfailure.123.011269
Novel Non-pharmaceutical Advancements in Heart Failure Management: The Emerging Role of Technology.
Nolan MT, Tan N, Neil CJ. · · 2022 · cited 2× · PMID 34488615 · DOI 10.2174/1573403x17666210831144141
Phenotype characterization of heart failure with preserved ejection fraction in medical device and surgical trials.
Araz K, Fioretti F, Ladak S, Obaidan M, et al · · 2025 · cited 1× · PMID 40857067 · DOI 10.1002/ehf2.15401

Verify or expand the search:

Other recruiting trials for Heart Failure, Diastolic

Currently open trials in the same condition.

NCT07199088 — Comparative Efficacy and Safety of Acetazolamide Versus Metolazone as an Adjunct to Standard Therapy in Patients With Ac · NA · recruiting
NCT05887271 — A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejec · Phase 2, PHASE3 · recruiting
NCT05989945 — HIDRAdenitis Suppurativa and HEART Disease · active not recruiting
NCT05752760 — Pilot Study Lp299v Supplementation in Chronic Heart Failure · NA · recruiting
NCT06084468 — Cardiac Structure and Function in Patients with Cystic Fibrosis · active not recruiting

Other Impulse Dynamics trials

Trials by the same sponsor.

NCT07112924 — CCM OPEN HF Registry · recruiting
NCT05064709 — Assessment of CCM in HF With Higher Ejection Fraction · NA · recruiting
NCT04755569 — Optimizer System With ODOCOR II CCM™ Leads · unknown
NCT03339310 — Evaluation of the Safety and Efficacy of the 2-lead OPTIMIZER® Smart System · NA · completed
NCT03102437 — Continued Access Protocol for the Evaluation of the OPTIMIZER Smart System · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03240237 (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 Impulse Dynamics
Last refreshed: 23 April 2024

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/NCT03240237.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing