CCM in Heart Failure With Preserved Ejection Fraction

Not Applicable

Completed

• Conditions: Heart Failure, Diastolic
• Interventions: Device: Optimizer SMART

• Registration Number: NCT03240237
• Lead Sponsor: Impulse Dynamics

Brief Summary

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.

Detailed Description

This is a pilot clinical study of CCM in addition to optimal medical therapy (OMT) over a 24 week period.The primary endpoint shall be mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score (reflecting integrated information on physical limitations, symptoms, self-efficacy, social interference and quality of life).

This pilot study will collect efficacy and safety data in heart failure patients having NYHA class II and III symptoms despite appropriate medication with baseline ejection fraction equal or greater than 50% (HFpEF populations).

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2018-05-01
• Primary Completion: 2023-07-25
• Study Completion: 2023-07-25
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCM therapy	Optimizer SMART	Optimizer SMART

Primary Outcome Measures

Name	Time	Method
KCCQ change	24 weeks	Mean change from baseline to 24 weeks in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score

Secondary Outcome Measures

Name	Time	Method
NT-proBNP	24 weeks	Mean Change in 24 weeks
NYHA class	24 weeks	Mean Change in 24 weeks
Echocardiography	24 weeks	LAVi and diastolic function: septal E' velocity, septal E/E' ratio

Trial Locations

Locations (17)

Uniwersytecki Szpital Kliniczny we Wrocław; 🇵🇱 Wrocław, Poland

Auxologico Institute; 🇮🇹 Milan, Italy

4 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ we Wroclawiu; 🇵🇱 Wroclaw, Poland

Hospital Na Homolce; 🇨🇿 Praha 5, Czechia

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

INRCA IRCCS Ancona; 🇮🇹 Ancona, Rome, Italy

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Hesse, Germany

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego zakład leczniczy Centralnego Szpitala Klinicznego; 🇵🇱 Warsaw, Poland

Friendly Society Private Hospital; 🇦🇺 Bundaberg, Queensland, Australia

St. John of God Bunbury; 🇦🇺 Bunbury, Australia

St. John of God Murdoch Hospital; 🇦🇺 Perth, Australia

Hospital General de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario 12 de Octubre Unidad de Insuficiencia Cardiaca y Trasplante Servicio de Cardiología, Planta 6. Bloque D.Ciber 8; 🇪🇸 Madrid, Spain

Santiago de Compostella -- Servicio de Cardiología y UCC/ Cardiology and Coronary Care Department Hospital Clínico Universitario. XXI de Santiago de Compostela SERGAS; 🇪🇸 Santiago De Compostela, C/ A Choupana S.n, Spain

Hospital Alvaro Cunquero; 🇪🇸 Vigo, Spain

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

West Lisbon Hospital Center, E.P.E., hereinafter referred to as CHLO, E.P.E; 🇵🇹 Lisbon, Portugal