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Potassium Nitrate Nicotinamide Riboside Propionyl-L-Carnitine Potassium C

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Potassium Nitrate Nicotinamide Riboside Propionyl-L-Carnitine Potassium C Protocol 844627- The MPMA HFpEF Trial KNO3 vs. KNO3 + NR + PLC vs. KCl Page 1 of 97 CLINICAL RESEARCH PROTOCOL INVESTIGATIONAL PRODUCT(S): Potassium Nitrate Nicotinamide Riboside Propionyl-L-Carnitine Potassium Chloride STUDY IRB Number 844627 NUMBER(S): Other Protocol CAMRIS: 735 Identifiers CHPS: PROTOCOL(S) TITLE: Matching Perfusion to Metabolic Activity in HFpEF REGULATORY SPONSOR: University of Pennsylvania FUNDING SPONSOR(S): National Institutes of Health PRINCIPAL INVESTIGATOR Payman Zamani, MD, MTR ORIGINAL PROTOCOL DATE: VERSION NUMBER: v1.0 VERSION DATE: 29 January 2021 Confidential – V1; 12/21/20 Protocol 844627- The MPMA HFpEF Trial KNO3 vs. KNO3 + NR + PLC vs. KCl Page 2 of 97 1 Study Summary ........................................................................................................ 7 1.1 Synopsis ............................................................................................................... 7 1.2 Key Roles and Study Governance ......................... Error! Bookmark not defined. 1.3 Schema ..................................................................................................................... 10 2 Introduction and RationalE .................................................................................... 11 2.1 Study Rationale .................................................................................................. 11 2.2 Background ........................................................................................................ 11 2.2.1 Pharmacokinetics, Pharmacodynamics and Toxicology ......................... 11 2.2.2 Assessment for Potential Study Products Drug-Drug, Drug-Device, Device-Device Interactions ......................................................................... 14 2.2.3 Clinical Adverse Event Profile .......................... Error! Bookmark not defined. 2.2.4 Dosing Rationale ................................................ Error! Bookmark not defined. 2.3 Risk/Benefit Assessment ........................................ Error! Bookmark not defined. 2.3.1 Known Potential Risks ................................................................................ 22 2.3.2 Known Potential Benefits ............................................................................ 22 2.3.3 Assessment of Potential Risks and Benefits .. Error! Bookmark not defined. 3 Study Objectives and Endpoints ........................................................................... 25 4 Study Plan ............................................................................................................... 29 4.1 Study Design ...................................................................................................... 29 4.2 Scientific Rationale for Study Design .............................................................. 29 4.3 Justification for Dose ........................................................................................ 29 4.4 End of Study Definition ..................................................................................... 29 5 Study Population .................................................................................................... 31 5.1 Inclusion Criteria ...................................................... Error! Bookmark not defined. 5.2 Exclusion Criteria .............................................................................................. 31 5.3 Lifestyle Considerations ................................................................................... 32 5.4 Screen Failures .................................................................................................. 33 5.5 Strategies for Recruitment and Retention ....................................................... 33 6 Study Intervention .................................................................................................. 35 6.1 Study Intervention(s) Administration ............................................................... 36 6.1.1 Study Intervention Description ................................................................... 36 6.1.2 Dosing and Administration ......................................................................... 36 6.2 Preparation/Handling/Storage/Accountability ................................................ 38 6.2.1 Acquisition and accountability ................................................................... 39 6.2.2 Formulation, Appearance, Packaging, and Labeling ................................ 40 6.2.3 Product Storage and Stability ........................... Error! Bookmark not defined. 6.2.4 Preparation ......................................................... Error! Bookmark not defined. 6.3 Measures to Minimize Bias: Randomization and Blinding ............................ 40 6.4 Study Intervention Compliance ........................................................................ 41 6.5 Concomitant Therapy ........................................................................................ 41 6.5.1 Rescue Medicine ................................................ Error! Bookmark not defined. 7 Study Intervention Discontinuation and Participant Discontinuation/Withdrawal .................................................................................. 42 7.1 Discontinuation of Study Intervention ............................................................. 42 7.2 Participant Discontinuation/Withdrawal from the Study ................................ 42 Confidential – V1; 12/21/20 Protocol 844627- The MPMA HFpEF Trial KNO3 vs. KNO3 + NR + PLC vs. KCl Page 3 of 97 7.3 Lost To Follow-Up .............................................................................................. 42 8 Study Assessment and Procedures ..................................................................... 44 8.1 Efficacy Assessments ....................................................................................... 44 8.2 Safety and Other Assessments ........................................................................ 53 8.3 Adverse Events and Serious Adverse Events ................................................ 53 8.3.1 Definition of Adverse Events (AE) .................... Error! Bookmark not defined. 8.3.2 Definition of Serious Adverse Events (SAE) ... Error! Bookmark not defined. 8.3.3 Classification of an Adverse Event .................. Error! Bookmark not defined. 8.3.4 Time Period and Frequency for Event Assessment and Follow-Up .. Error! Bookmark not defined. 8.3.5 Adverse Event Reporting .................................. Error! Bookmark not defined. 8.3.6 Serious Adverse Event Reporting .................... Error! Bookmark not defined. 8.3.7 Reporting Events to Participants ..................... Error! Bookmark not defined. 8.3.8 Events of Special Interest ................................. Error! Bookmark not defined. 8.3.9 Reporting of Pregnancy .................................... Error! Bookmark not defined. 8.4 Unanticipated Problems .......................................... Error! Bookmark not defined. 8.4.1 Definition of Unanticipated Problems (UP) ...... Error! Bookmark not defined. 8.4.2 Unanticipated Problem Reporting .................... Error! Bookmark not defined. 8.4.3 Reporting Unanticipated Problems To Participants .... Error! Bookmark not defined. 9 Statistical Considerations ...................................................................................... 63 9.1 Statistical Hypotheses ....................................................................................... 63 9.2 Sample Size Determination ..................................... Error! Bookmark not defined. 9.3 Populations for Analyses .................................................................................. 63 9.4 Statistical Analyses ................................................. Error! Bookmark not defined. 9.4.1 General Approach .............................................. Error! Bookmark not defined. 9.4.2 Analysis of the Primary Efficacy Endpoint(s) . Error! Bookmark not defined. 9.4.3 Analysis of the Secondary Endpoint(s) ........... Error! Bookmark not defined. 9.4.4 Safety Analyses .................................................. Error! Bookmark not defined. 9.4.5 Baseline Descriptive Statistics ......................... Error! Bookmark not defined. 9.4.6 Planned Interim Analyses ................................. Error! Bookmark not defined. 9.4.7 Sub-Group Analyses .......................................... Error! Bookmark not defined. 9.4.8 Tabulation of Individual Participant Data ........ Error! Bookmark not defined. 9.4.9 Exploratory Analyses ........................................ Error! Bookmark not defined. 10 Supporting Documentation and Operational Considerations ............................ 66 10.1 Regulatory, Ethical, and Study Oversight Considerations ............................ 66 10.1.1 Informed Consent Process ......................................................................... 66 10.1.2 Study Discontinuation and Closure ........................................................... 66 10.1.3 Confidentiality and Privacy ......................................................................... 67 10.1.4 Future Use of Stored Specimens and Data ............................................... 67 10.1.5 Safety Oversight ........................................................................................... 68 10.1.6 Clinical Monitoring ....................................................................................... 68 10.1.7
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