Heart Failure With Preserved Ejection FractionNCT04287946
Endovascular GSN Ablation in Subjects With HFpEF
A study testing Ablation in people with Heart Failure With Preserved Ejection Fraction, run by Axon Therapies, Inc. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Feb 2020to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Georgia2 sites
Tbilisi Heart and Vascular Clinic
Tbilisi
Tbilisi Heart Center
Tbilisi
About this study
Official title: Endovascular Ablation of the Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction - First In-human Feasibility Study
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.
- Being tested
- Ablation
- Keywords
- Heart Failure, Preserved Ejection Fraction
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Ablation of a single-side of the greater splanchnic nerve
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Not described Receives: Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE)
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
Measured: 1 month
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
Measured: 1 month
Secondary outcomes (4)
Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality
Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality
Measured: 6 month
Change in average PCWP as compared to baseline
Change in average PCWP as compared to baseline
Measured: 1 month
Secondary Efficacy Endpoint
Change in the quality of life according to the Kansas City Cardiomyopathy Questionnaire (KCCQ) between baseline and follow-up
Measured: 1, 3, 6 months
Secondary Efficacy Endpoint
Change in exercise tolerance as measured by the 6 minute walk test (6MWT) between baseline and follow-up
Measured: 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Feb 2020
- Primary completionJun 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axon Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Howard Levin, MD, Study chair, Coridea, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287946
- Sponsor's protocol ID
- 08938
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2020
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Fudim M, Zirakashvili T, Shaburishvili N, Shaishmelashvili G, Sievert H, Sievert K, Reddy VY, Engelman ZJ, Burkhoff D, Shaburishvili T, Shah SJ. Transvenous Right Greater Splanchnic Nerve Ablation in Heart Failure and Preserved Ejection Fraction: First-in-Human Study. JACC Heart Fail. 2022 Oct;10(10):744-752. doi: 10.1016/j.jchf.2022.05.009. Epub 2022 Jul 6.
PubMed 36175060
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Ablation of the Greater Splanchnic Nerve in Subjects Having Heart Failure With Preserved Ejection Fraction - First In-human Feasibility Study
- ClinicalTrials.gov ID
- NCT04287946
- Acronym / sponsor ID
- 08938
- Keywords
- Heart Failure, Preserved Ejection Fraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Axon Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Device: Ablation |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationAblation of a single-side of the greater splanchnic nerve | Device | Ablation |
Primary outcome
Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE)
Time frame: 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
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
Time frame: 1 month
Mean change of PCWP with exercise after index procedure ablation as compared to baseline
4 secondary outcomes
Incidence of MACCRE, all serious adverse events, all-cause mortality, CV mortality and HF related mortality
Time frame: 6 month
Change in average PCWP as compared to baseline
Time frame: 1 month
Secondary Efficacy Endpoint
Time frame: 1, 3, 6 months
Secondary Efficacy Endpoint
Time frame: 1, 3, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Derived from this study: PubMed 36175060Fudim M, Zirakashvili T, Shaburishvili N, Shaishmelashvili G, Sievert H, Sievert K, Reddy VY, Engelman ZJ, Burkhoff D, Shaburishvili T, Shah SJ. Transvenous Right Greater Splanchnic Nerve Ablation in Heart Failure and Preserved Ejection Fraction: First-in-Human Study. JACC Heart Fail. 2022 Oct;10(10):744-752. doi: 10.1016/j.jchf.2022.05.009. Epub 2022 Jul 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Levin, MD study chair
Coridea, Inc.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with Heart Failure With Preserved Ejection Fraction, run by Axon Therapies, Inc. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of one or more of the following: major adverse cardiac, cerebrovascular embolic, or renal event (MACCRE) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04287946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.