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Heart Failure Studies

PROHIBIT-SODIUM
Meals with 1500mg vs 3000mg of Sodium for 3 months post ADHF hospitalization

Inclusion criteria:

  1. Age ≥ 21 years at screening
  2. Recent (≤ 1 year) EF ≤ 40%
  3. Standard HF treatment, including ACEI/ARB & beta-blockers & aldosterone antagonists, unless contraindicated or intolerant
  4. Able to consume research diet (e.g. no dysphagia etc.)
  5. Systolic blood pressure ≥100 mmHg
  6. > 3000 mg/d sodium excretion (by 24-hr urinary sodium)

Pr Endpoint: Diet safety, adherence, CV events
Identification: Inpatient
Intervention: Outpatient

RELAX-HF
Serelaxin for 48 hours in ADHF

Inclusion criteria:

  1. Able to be randomized within 16 hours from presentation to the hospital
  2. Systolic BP ≥ 125 mmHg
  3. Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation and the start of screening
  4. All of the following:
    Persistent dyspnea even after at least IV 40 mg of lasix
    Pulmonary congestion on chest radiograph
    BNP ≥ 500 pg/mL or NT-proBNP ≥ 2,000 pg/mL
  5. GFR between 25-75ml/min/1.73m2

Pr Endpoint: 6month CV mortality
Identification: Inpatient
Intervention: Inpatient

INDIE-HF
Inorganic Nitrite Delivery to Improve Exercise Capacity in HFpEF HF Network

Inclusion criteria:

  1. Age ≥ 40, EF ≥ 50%, NYHA II-IV
  2. One of the following:
    Previous hospitalization for HF or RHC PCWP ≥ 15 or LVEDP ≥ 18 or with exercise (PCWP ≥ 25) or NT-proBNP > 400 pg/ml) or BNP(> 200 pg/ml) or In Echo medial E/e’ ratio ≥ 15 and/or left atrial enlargement and chronic treatment with a loop diuretic for signs or symptoms of heart failure
  3. Peak VO2 ≤ 75% predicted with peak respiratory exchange ratio ≥ 1.0 CPET
  4. No chronic nitrate therapy or not using intermittent subl nitro, No daily use of phosphodiesterase 5 inhibitors or sGC activators

Identification: Outpatient
Intervention: Outpatient

VICTORIA
VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction

Inclusion criteria:

  1. Age ≥ 18, EF < 45% within 12 months, NYHA II-IV
  2. Have a previous HF hospitalization within 6 months prior to randomization or IV diuretic treatment for HF within 3 months prior to randomization
  3. NT-proBNP ≥ 1000 pg/mLSR and ≥ 1600 pg/mL in AF
  4. NO concurrent or anticipated use oflong-acting nitrates or NO donors including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or NTG patch, and molsidomine

Identification: Outpatient
Intervention: Inpatient

LIFE
Entresto for 6 months in patients with Advanced HF

Inclusion criteria:

  1. Advanced HFrEF defined as including ALL
    a. LVEF ≤ 35%
    b. GFR 20 - 60
    c. NYHA class IV symptomatology (INTERMACS profile 3 - 6)
    d. Minimum of 3 months GDMT or intolerant to therapy
  2. SBP ≥ 90 mmHg
  3. NT-proBNP ≥ 800 pg/mL
  4. Any one or more:
    Inotropic therapy currently, or for ≥ 5 days in the past 6 months , ≥ 1 HF hospitalizations , LVEF ≤ 25%, PCW ≥ 20 mmHg, Peak VO2 < 55% predicted or peak VO2 ≤ 16 for men or ≤ 14 for women, Estimated GFR < 45 History of IABP within the past 6 months
  5. Age < 85

Identification: Outpatient
Intervention: Outpatient