Heart Failure Clinical Trials

Listed below are clinical trials being conducted on Heart Failure. For more information on Heart Failure trials or to refer a patient to a currently recruiting study, please contact Gail Snell, RN, at gsnell@emory.edu or 404-712-0531. 

Completed Heart Failure Clinical Trials

ATHENA-HF

ATHENA-HF: Aldosterone Targeted Neurohormonal Combined with Natriuesis Therapy in HF

PI: Andrew L. Smith, MD

Purpose: The primary objective of this study is to test the hypothesis that high-dose spironolactone will lead to greater proportional reduction in NT-proBNP levels from randomization to 96 hours over standard of care.

Inclusion Criteria: 

  • Male or female patient ≥21 years old
  • Admitted to hospital for AHF with at least 1 symptom (dyspnea, orthopnea, or fatigue) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) of congestion
  • Patient must be randomized within 24 hours of first IV diuretic dose administered for the current episode of decompensation (regardless of where the diuretic was given e.g. office, ED, ambulance, hospital etc.)
  • Estimated GFR of ≥30 mL/min/1.73m2 determined by the MDRD equation
  • Serum K+ ≤5.0 mmol/L at enrollment
  • NT-proBNP ≥1000 pg/mL or BNP ≥250 pg/mL, measured within 24h from randomization
  • Not on MRA or on low-dose spironolactone (12.5 mg or 25 mg daily) at baseline

FIGHT

FIGHT - Functional Impact of GLP-1 for Heart Failure Treatment

PI: Andrew L. Smith, MD

Purpose: The primary objective is to test the hypothesis that, compared with placebo, therapy with Subcutaneous (SQ) GLP-1 agonist in the post-Acute Heart Failure Syndrome (AHFS) discharge period will be associated with greater clinical stability at six months as assessed by a composite clinical endpoint.

Inclusion Criteria:

  1. Age ≥ 18 years
  2. AHFS as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
  3. AHFS is the primary cause of hospitalization
  4. Prior clinical diagnosis of HF
  5. Left Ventricular Ejection Fraction(LVEF) ≤ 40% during the preceding 3 months (if no echo within the preceding 3 months, an LVEF ≤ 30% during the preceding three years is acceptable)
  6. On evidence-based medication for HF (including beta-blocker and ACE-inhibitor/ARB) or previously deemed intolerant
  7. Use of at least 80 mg or furosemide total daily dose (or equivalent) prior to admission for AHFS (a lower dose of a loop diuretic combined with a thiazide will count as an "equivalent")
  8. Willingness to provide informed consent

IRONOUT-HF

IRONOUT-HF: Oral Iron Repletion effects on Oxygen UpTake in Heart Failure 

PI: Andrew L. Smith

Purpose: The purpose of this study is to determine if oral iron (FE) polysaccharide is superior to oral placebo in improving functional capacity as measured by change in peak VO2 by CPET (Cardiopulmonary Exercise Testing) , of a broad population of patients with HFrEF (Heart Failure Exercise Testing) and Fe deficiency at 16 weeks.

Hypothesis: In a broad population of HFrEF patients with Fe deficiency, compared to oral placebo, therapy with oral Fe polysaccharide will be associated with improvement in functional capacity at 16 weeks as assessed by CPET.

Inclusion Criteria: 

  1. Age >18 years
  2. Previous clinical diagnosis of heart failure with current NYHA Class II-IV symptoms LVEF≤0.40 within 1 year prior to consent, and ≥3 months after a major change in cardiac status (i.e. CABG or CRT).
  3. Serum ferritin between 15-100 ng/ml or serum ferritin between 100-299 ng/ml with transferrin saturation <20%
  4. Hemoglobin 9.0-13.5 g/dL at time of enrollment
  5. Stable evidence-based medical therapy for HF (including beta-blocker and ACE-inhibitor/ARB unless previously deemed intolerant) for 30 days prior to randomization. Changes in diuretic dose guided by a patient-directed flexible dosing program are considered stable medical therapy.
  6. Willingness to provide informed consent

SECRET

Randomized, Double-Blind, Placebo-Controlled Study of the Short-Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure with Challenging Volumne Management

PI: Divya Gupta, MD

Purpose: The purpose of this study is to evaluate the short term efficacy and safety of tolvaptan in subjects hospitalized for worsening heart failure who have volume overload and one of the following: renal insufficiency, or hyponatremia or inadequate response to diuretic therapy. The primary variable for assessing efficacy will be self-assessed 7-point dyspnea score at 8 and 16 hours.

Inclusion Criteria:

  1. Subjects hospitalized for worsening heart failure and randomized within 36 hours of initial presentation.
  2. Males and females 18 years of age or older.
  3. NYHA Class III or IV on admission to the hospital.
  4. Able to understand content of and willing to provide written informed consent
  5. Dyspnea, measured by the 5-point current dyspnea scale (moderately short of breath or worse), within 2 hours of randomization and dosing.The following must be met within 12 hours of randomization.
  6. The subject must have signs of extracellular volume expansion, defined as two or more of the following five: Signs of RHF ( jugular venous distention, pitting edema (≥1+), ascites) and/or Signs of LHF (pulmonary congestion on chest x-ray, pulmonary rales)
  7. Have at least one of the following:
    • eGFR < 60ml/min/1.73m2, OR
    • serum sodium ≤ 134 mEq/L, OR
    • urine output ≤ 125 ml/hr over anytime frame of at least 2 hours, following administration of IV furosemide of at least 40mg. See table below.

Time Period (hr) Cumulative UO (mL) 2 <250 3 <375 4 <500 5 <625 6 <750 7 <875 8 <1000

SILVER -HF

SILVER-AMI: Risk Stratification in Older Persons With Acute Myocardial Infarction

PI: Andreas Kalogeropoulos, MD

Purpose: The objectives of this study are to identify risk factors for all-cause hospital readmission, mortality and decline in health status following hospitalization for AMI among older persons and to develop and validate risk stratifiction tools for hospital readmission, mortality and decline in health status following hospitalization for AMI among older persons.

Inclusion Criteria:

  1. 1. Age ≥75 years upon admission to the hospital
  2. Elevation of cardiac markers within 24 hours of presentation to the hospital
    a. Troponin must rise above the upper limit of normal established by the hospital as a determinate of cardiac injury with a subsequent fall
  3. Any one of the following:
    • Symptoms of ischemia
    • ECG with ischemic changes
    • Imaging evidence of Infarction 
    • Intracoronary thrombus on angiography

TACTICS-HF

Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure

PI: Divya Gupta, MD

Purpose: The purpose of this study is to see if taking tolvaptan by mouth in addition to the regular treatment received for shortness of breath due to heart failure will work better than the regular treatment alone. The study will also look to see if other symptoms of heart failure or problems associated with heart failure treatments, like changes in kidney function, are affected by tolvaptan.

Inclusion Criteria:

  • ≥ 18 years of age
  • Daily oral dose of furosemide between ≥ 40 mg(or equivalent)
  • Identified within 24 hours of presentation, defined for purposes of this study as the time of initial dose of intravenous loop diuretic
  • Prior clinical HF diagnosis that was treated with oral loop diuretics for at least 1 month
  • Admission for acute decompensated Heart Failure (HF) as determined by
    • dyspnea at rest or with minimal exertion
    • Brain Natriuretic Peptide (BNP) > 400 or NTproBNP > 2000 pg/mL