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New treatment option for Heart Failure With Preserved Ejection Fraction (HFpEF
Official title Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects Having HFpEF
ClinicalTrials.gov ID: NCT04592445
What this study is testing
- What it's testing
- The purpose of this clinical study is to evaluate the safety and early effectiveness of a catheter-based procedure that treats a nerve called the right greater splanchnic nerve. The study includes people who have heart failure with preserved ejection fraction (HFpEF).
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Chronic heart failure, defined as:
- Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for \>30 days, AND
- NYHA class II with a history of \>NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea...
- At least one of the following: i. ≥1 HF hospital admission (with HF as the primary diagnosis) including treatment with intravenous (IV) diuretics or...
- Ongoing stable GDMT HF management (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2022 ACCF/AHA Guideline...
You likely can't join if
- MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current...
- Cardiac resynchronization therapy initiated within 3 months prior to screening.
- Advanced heart failure defined as one or more of the following:
- ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.
- Inotropic infusion (continuous or intermittent) within 6 months prior to screening.
- Subject is on the cardiac transplant waiting list.
See the full eligibility criteria
Who can join
- Chronic heart failure, defined as:
- Symptoms of HF requiring current (intermittent or continuous) treatment with diuretics for \>30 days, AND
- NYHA class II with a history of \>NYHA class II in the past year, NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening or...
- At least one of the following: i. ≥1 HF hospital admission (with HF as the primary diagnosis) including treatment with intravenous (IV) diuretics or urgent unplanned treatment with IV diuretics in healthcare facility...
- Ongoing stable GDMT HF management (unless unable to tolerate GDMT) and management of potential comorbidities according to the 2022 ACCF/AHA Guideline for the Management of Heart Failure (Class 1 and 2a recommendations)...
- LVEF ≥50% (site-determined by transthoracic echocardiography) within the past 6 months.
- Age ≥40 years.
- Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.
What rules you out
- MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.
- Cardiac resynchronization therapy initiated within 3 months prior to screening.
- Advanced heart failure defined as one or more of the following:
- ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.
- Inotropic infusion (continuous or intermittent) within 6 months prior to screening.
- Subject is on the cardiac transplant waiting list.
- Presence of or prior history of mechanical circulatory support for HF.
- Poor left heart compliance as determined by pulse-wave Doppler transmitral early-to-late (E/A) ratio \>2.0 assessed by the screening echocardiogram. The Screening Committee will evaluate left heart function if the...
- Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) \<12 mm or right ventricular (RV) fractional area change (FAC) \<25% assessed by the screening echocardiogram.
- Body mass index (BMI) \>45 kg/m2.
- 6-minute walk test distance \ 450 meters.
- Admission for HF within the 30 days prior to planned index procedure.
- Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of...
- Orthostatic pulse pressure change from supine to standing decrease of \>10mmHg in the absence of a HR increase \>15bpm
- Postural orthostatic tachycardia syndrome or preload insufficiency syndrome.
- Systolic BP \ 170 mmHg despite appropriate medical management.
- Baseline screening ECG resting HR \>100 beats per minute or ventricular tachycardia.
- Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.
- Left ventricular EF \<40% within the 3 years prior to screening unless reduced EF was transient and associated with an acute event.
- Presence of significant valve disease defined by the site cardiologist as:
- Greater than mild mitral valve stenosis.
- Greater than moderate mitral valve regurgitation.
- Greater than moderate-to-severe tricuspid valve regurgitation.
- Greater than moderate aortic valve stenosis or regurgitation.
- Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).
- History of clinically significant liver cirrhosis.
- Prior weight loss surgery
- Dialysis dependent; or estimated GFR \<25 ml/min/1.73 m2 by CKD-EPI creatinine equation.
- Arterial oxygen saturation \<90% on room air.
- Chronic pulmonary disease requiring continuous home oxygen OR hospitalization for exacerbation of chronic pulmonary disease (including intubation) in the 12 months before study entry OR known history of GOLD Class III...
- Participating in conflicting investigational drug or device study that is not completed within 30 days prior to the screening visit.
- Life expectancy \<12 months for non-cardiovascular reasons.
- Any condition, or history of illness or surgery that, in the opinion of the site investigator or Screening Committee, might confound the results of the study or pose additional risks to the patient.
- Females who are pregnant or lactating or planning to become pregnant during the next year.
- Any of the following measured by screening right heart catheterization:
- Mean right atrial pressure (RAP) \>20 mmHg at rest
- Cardiac index \<2.0 L/min/m2 at rest
- Pulmonary vascular resistance (PVR) \>4 Wood units Exclusion Criteria Assessed During the index procedure:
- Vessel tortuosity or variant vascular anatomy that could preclude the access or maneuvering of the treatment device from the access site to target vessel. This includes previous spine surgery that may impact the ability...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- La Jolla, California, United States
- San Francisco, California, United States
- Chicago, Illinois, United States
- Springfield, Illinois, United States
- Indianapolis, Indiana, United States
- Houma, Louisiana, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Rochester, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Charleston, South Carolina, United States
- Richmond, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; La Jolla, California, United States; San Francisco, California, United States; Chicago, Illinois, United States; Springfield, Illinois, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.