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A Phase 2 Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure

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ClinicalTrials.gov Identifier: NCT02914665
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Stealth BioTherapeutics Inc.

Brief Summary:
This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of short term treatment with elamipretide in patients hospitalized with congestion due to heart failure

Condition or disease Intervention/treatment Phase
Heart Failure Drug: elamipretide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Cardiac and Renal Effects of Short Term Treatment With Elamipretide in Patients Hospitalized With Congestion Due to Heart Failure
Actual Study Start Date : October 20, 2016
Actual Primary Completion Date : November 27, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: 20 mg elamipretide
20 mg elamipretide once daily for 7 consecutive days
Drug: elamipretide
20 mg elamipretide administered intravenously once daily for 7 consecutive days
Other Name: MTP-131, Bendavia

Placebo Comparator: Placebo
Placebo once daily for 7 consecutive days
Drug: Placebo
Placebo administered intravenously once daily for 7 consecutive days




Primary Outcome Measures :
  1. Change in NT-proBNP between Baseline and Day 8/Early Discharge [ Time Frame: Baseline to Day 8 ]

Secondary Outcome Measures :
  1. Number of patients staying in the same functional renal function class measured with MDRD formula compared to the number of patients with decreasing or increasing renal function measured with MDRD formula [ Time Frame: Baseline to Day 3 and Day 8 ]
  2. Number of patients showing a decrease in body weight compared to baseline as well as number of patients showing either no decrease or an increase in body weight compared to baseline [ Time Frame: Baseline to Day 3 and Day 8 ]
  3. Calculation of decrease or increase in body weight normalised to the average dose (in mg) of furosemide administered [ Time Frame: Baseline to Day 3 and Day 8 ]
  4. The patient and physician global assessment is a 7-point scale which either the patient or the physician will assess from 0 to 10 and will be mathematically averaged on a daily basis in order to compare the different averages throughout the study. [ Time Frame: Baseline to Day 3 and Day 8 ]
  5. The average daily dose of diuretic (furosemide - adjusted for thiazide dose if administered) between baseline and Day 3 and Day 8/Early Discharge [ Time Frame: Baseline to Day 3 and Day 8 ]
  6. All adverse events, serious adverse events and SUSARs will be summarised per treatment group, namely elamipretide versus placebo, and compared at the end of the study. [ Time Frame: Baseline to Day 8 ]
  7. Half-life (T1/2) [ Time Frame: Baseline to Day 8 ]
  8. Area under the concentration - time curve from 0-24 h (AUC 0-24) [ Time Frame: Baseline to Day 8 ]
  9. Area under the concentration - time curve from 0- infinity (AUC 0-∞) [ Time Frame: Baseline to Day 8 ]
  10. Peak Plasma Concentration (Cmax) [ Time Frame: Baseline to Day 8 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A history of chronic heart failure for at least 1 month
  • Treated with ≥40 mg/day of furosemide or bumetanide ≥1 mg/day or torasemide ≥10 mg/day for at least 1 month
  • In-hospital observation/admission and treatment for ≤72 hours and primary cause for admission is heart failure with persistent congestion in the opinion of the Investigator (i.e. at least +2 pitting oedema and/or an estimated 8 kg gain in weight over baseline over the past 4 weeks) requiring intravenous loop diuretic therapy
  • Sufficiently severe oedema to justify treatment by an intravenous infusion of furosemide of 10 mg/hour for at least 48 hours
  • Systolic blood pressure >90 mmHg and considered to be haemodynamically stable, in the opinion of the Investigator
  • History of left ventricular ejection fraction (LVEF) ≤40% confirmed in the last 18 months
  • NT-proBNP >1500 pg/ml or BNP >500 pg/ml
  • An eGFR of >30 mL/min/1.73 m2 using the eGFR (mL/min/1.73 m2) = 175 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African American)

Exclusion Criteria:

  • Acute coronary syndrome, stroke, or transient ischemic attack (TIA), coronary or peripheral revascularization procedures, valve procedures, OR any major surgical procedure within the previous 6 weeks
  • Invasive cardiac investigation and/or treatment (i.e. coronary angiography, percutaneous coronary intervention [PCI] or surgery) or other surgical procedure planned in the next 4 weeks
  • Use of intravenous radiographic contrast agent within 72 hours prior to screening or planned use during the study
  • Severe, in the investigators opinion, uncorrected valve disease or congenital heart disease as the cause for cardiac decompensation
  • Acute mechanical cause of decompensated heart failure such as papillary muscle rupture
  • Obstructive or infiltrative cardiomyopathy (e.g. amyloid, sarcoid, etc), suspected acute myocarditis, or heart failure related to an untreated metabolic condition (e.g. haemochromatosis)
  • Second or third degree heart block unless the subject has a ventricular pacemaker
  • Atrial fibrillation/flutter with sustained ventricular response of >130 bpm
  • Placement of a ventricular resynchronization device within the previous 6 weeks
  • Treatment or planned treatment with intravenous inotropic agents other than digoxin at any time on this admission
  • Receipt of intravenous vasodilator therapy ≤ 6 hours prior to randomization
  • The presence of any mechanical assist device or listed for or a history of a heart transplant
  • Severe respiratory disease or anticipated need for mechanical respiratory support (i.e. mechanical ventilation)
  • Anuric in the previous 24 hours
  • Haemoglobin <9 g/dL at screening or planned blood transfusions in the next 30 days
  • Serum potassium >5.5 mEq/L
  • Marked proteinuria suggestive of nephrotic syndrome
  • Estimated GFR (eGFR) as per MDRD equation <30 ml/min
  • Serum albumin of < 2.8 g/dL
  • Liver enzymes (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) elevation >5 times the upper limit of normal (ULN)
  • Total bilirubin >2.0 times ULN in the absence of Gilbert's Syndrome
  • Current or planned ultrafiltration, paracentesis, haemofiltration or dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914665


Locations
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Sponsors and Collaborators
Stealth BioTherapeutics Inc.
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Responsible Party: Stealth BioTherapeutics Inc.
ClinicalTrials.gov Identifier: NCT02914665    
Other Study ID Numbers: SPIHF-204
2016-000126-19 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Keywords provided by Stealth BioTherapeutics Inc.:
Heart failure
diuresis
dropsy
congestion
elamipretide
MTP-131
Bendavia™
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases