Using the Reprieve System to relieve heart failure symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the Reprieve System in decongesting patients suffering from acute decompensated heart failure. Participants must be hospitalized with specific symptoms and signs of heart failure and be above their dry weight. The intervention involves the use of the Reprieve System to potentially improve their condition during hospitalization.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema/swelling) AND 1 sign (peripheral edema, ascites, jugular venous distension, pulmonary vascular congestion on chest radiography)
2. ≥10 lb. (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
3. Patients ≥ 18 years of age able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Inability to place Foley catheter or IV catheter or other urologic issues that would predispose the patient to a high rate of urogenital trauma or infection with catheter placement.
2. Hemodynamic instability as defined by any of the following: systolic blood pressure \<90 mmHg, use of vasopressors, use of IV inotropes to treat hypotension (systolic blood pressure \<90 mm Hg) or suspected/confirmed low cardiac output/shock, mechanical circulatory support, uncontrolled arrhythmias, active severe bleeding, or confirmed or suspected cardiogenic shock. Note: In the absence of the above conditions, use of inotropes to augment diuresis is permitted.
3. Dyspnea due primarily to non-cardiac causes (e.g., severe chronic obstructive pulmonary disease or pneumonia).
4. Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
5. Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy (RRT).
6. Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, known severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment (within previous week), or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
7. Inability to follow instructions or comply with follow-up procedures.
8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the protocol instructions or follow-up procedures.
9. Severe baseline electrolyte abnormalities (e.g., serum potassium \<3.0 mEq/L or magnesium \<1.3 mEq/L). Note: These are based on baseline/screening labs. Subjects whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.
10. Serum sodium \<135 mmol/L or history of severe hyponatremia
11. Poorly controlled diabetes
12. Enrollment in another interventional trial during the index hospitalization
13. Life expectancy less than 3 months
14. Women who are pregnant or intend to become pregnant.

Where it's running

• Tbilisi Heart and Vascular Clinic
  Tbilisi, Georgia Recruiting

Study contacts

• Principal investigator: Tamaz Shaburishvili, MD — Tbilisi Heart and Vascular Clinic
• Study coordinator: Tony Fields
• Email: tfields@reprievecardio.com
• Phone: +1-650-224-3884

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating a noninvasive tissue sensor to detect cardiogenic shock earlier in heart patients

  This pilot, noninvasive study tests whether the NIRSense wearable can help detect deterioration in adults with cardiogenic shock risk due to heart attack or heart failure.

  Recruiting NIRSense Inc. · Weston, Florida · NCT07825363

• BEAT-SHOCK: Baseline Registry for Acute Cardiogenic Shock at Basel

  This registry collects and shares data on adults with cardiogenic shock admitted to University Hospital Basel to help understand how these patients are treated and how they fare.

  Recruiting University Hospital, Basel, Switzerland · Basel, Canton of Basel-City · NCT07643610

• Daily lung ultrasound to see if it shortens hospital stays for adults with acute decompensated heart failure

  This study tests whether daily lung ultrasound can shorten hospital stays and reduce readmissions for adults with acute decompensated heart failure.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07572955

• Adding extra diuretics to standard care for acute decompensated heart failure

  This trial will test whether adding empagliflozin, acetazolamide, or metolazone to loop diuretics helps adults hospitalized with acute decompensated heart failure remove fluid and feel better.

  Recruiting Phase 2 Tanta University · Tanta · NCT07372040

• Acetazolamide versus metolazone added to usual diuretics for acute decompensated heart failure

  This trial will test whether adding acetazolamide or metolazone to standard diuretics works better and is safer for adults hospitalized with acute decompensated heart failure.

  Recruiting University of Health Sciences Lahore · Chak Eighty-seven -Twelve Left, Punjab Province · NCT07199088

• Fluid removal with the Reprieve System for acute decompensated heart failure

  This trial will test whether the Reprieve System removes excess fluid more effectively than standard IV diuretics in adults hospitalized with acute decompensated heart failure who are at risk for diuretic resistance.

  Recruiting at 49 sites Reprieve Cardiovascular, Inc · Irvine, California and 49 other locations · NCT06898515

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.