Endovascular GSN Ablation in Subjects With HFpEF

Not Applicable

• Conditions: Heart Failure With Preserved Ejection Fraction

• Registration Number: NCT04287946
• Lead Sponsor: Axon Therapies, Inc.

Brief Summary

The purpose of this study is to evaluate the safety and potential benefits of single-side block of a nerve that connects to the intestines, liver and spleen called the "greater splanchnic nerve" for the treatments of patients with symptomatic heart failure who have normal pumping of the heart. The study will be performed in patients whose heart failure is not responding well to standard treatments and remain symptomatic.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2024-06
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Chronic heart failure
• Transthoracic echocardiographic evidence of diastolic dysfunction
• Ongoing stable GDMT HF management and management of potential comorbidities
• LVEF ≥50% in the past 3 months

Key

Exclusion Criteria

• Cardiac resynchronization therapy initiated within the past 6 months
• Advanced heart failure
• Admission for HF within the past 30 days
• Presence of significant valve disease
• Mean right atrial pressure (RAP) >20mmHg during hemodynamic screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean change of PCWP with exercise after index procedure ablation as compared to baseline	1 month	Mean change of PCWP with exercise after index procedure ablation as compared to baseline
Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE)	1 month	Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE) through 1-month follow up based on Independent Physician Adjudicator (IPA) assessment: Cardiovascular death; Embolic stroke; Device or procedure-related adverse cardiac events

Secondary Outcome Measures

Name	Time	Method
Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality	6 month	Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality
Secondary Efficacy Endpoint	1, 3, 6 months	Change in exercise tolerance as measured by the 6 minute walk test (6MWT) between baseline and follow-up
Change in average PCWP as compared to baseline	1 month	Change in average PCWP as compared to baseline

Trial Locations

Locations (3)

Nemocnice Na Homolce; 🇨🇿 Praha, Czechia

Tbilisi Heart and Vascular Clinic; 🇬🇪 Tbilisi, Georgia

Tbilisi Heart Center; 🇬🇪 Tbilisi, Georgia