Trial Outcomes & Findings for Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure (NCT NCT03446651)
NCT ID: NCT03446651
Last Updated: 2024-01-30
Results Overview
Volumex is albumin labeled with the iodine isotope I-131 and is an FDA-approved method used to determine total blood volume. A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of blood collection will be compared across the 7 day collection period between intervention and placebo arms.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
50 participants
Primary outcome timeframe
Daily for 7 days
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
Lysine Chloride
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Lysine Chloride: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Placebo
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
Placebo: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
|
Overall Study
Participated in Open Label Portion
|
5
|
0
|
|
Overall Study
Completed 1st Visit
|
17
|
18
|
|
Overall Study
Completed Final Visit
|
13
|
18
|
|
Overall Study
COMPLETED
|
13
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
Lysine Chloride
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Lysine Chloride: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Placebo
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
Placebo: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Open Label Participants
|
5
|
0
|
Baseline Characteristics
Mechanism and Effects of Manipulating Chloride Homeostasis in Acute Heart Failure
Baseline characteristics by cohort
| Measure |
Lysine Chloride
n=22 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Lysine Chloride: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Placebo
n=18 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
Placebo: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 13.61 • n=5 Participants
|
58.61 years
STANDARD_DEVIATION 13.68 • n=7 Participants
|
56.30 years
STANDARD_DEVIATION 13.63 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Systolic blood pressure
|
120.32 mmHg
STANDARD_DEVIATION 24.66 • n=5 Participants
|
129.44 mmHg
STANDARD_DEVIATION 28.03 • n=7 Participants
|
124.43 mmHg
STANDARD_DEVIATION 26.28 • n=5 Participants
|
|
Diastolic blood pressure
|
71.59 mmHg
STANDARD_DEVIATION 10.82 • n=5 Participants
|
78.0 mmHg
STANDARD_DEVIATION 15.43 • n=7 Participants
|
74.47 mmHg
STANDARD_DEVIATION 13.31 • n=5 Participants
|
|
Heart rate
|
80.27 bpm
STANDARD_DEVIATION 16.93 • n=5 Participants
|
88.11 bpm
STANDARD_DEVIATION 21.61 • n=7 Participants
|
83.80 bpm
STANDARD_DEVIATION 19.33 • n=5 Participants
|
PRIMARY outcome
Timeframe: Daily for 7 daysPopulation: Intention to treat
Volumex is albumin labeled with the iodine isotope I-131 and is an FDA-approved method used to determine total blood volume. A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of blood collection will be compared across the 7 day collection period between intervention and placebo arms.
Outcome measures
| Measure |
Lysine Chloride
n=22 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Lysine Chloride: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Placebo
n=18 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
Placebo: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
|---|---|---|
|
Change in Blood Volume
|
-320 mL
Standard Deviation 689
|
-447 mL
Standard Deviation 520
|
SECONDARY outcome
Timeframe: Daily for 7-daysN-terminal prohormone of brain natriuretic peptide (NTpro-BNP) is used to screen and diagnosis of acute congestive heart failure (CHF) and can be used to establish prognosis in heart failure. A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of NTpro-BNP will be compared across the 7 day collection period between intervention and placebo arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 7-daysPopulation: Intention to treat
A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of serum creatinine will be compared across the 7 day collection period between intervention and placebo arms.
Outcome measures
| Measure |
Lysine Chloride
n=22 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Lysine Chloride: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Placebo
n=18 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
Placebo: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
|---|---|---|
|
Change in Serum Creatinine
|
0.00 mg/dL per day
Interval -0.04 to 0.04
|
0.04 mg/dL per day
Interval 0.02 to 0.06
|
SECONDARY outcome
Timeframe: Daily for 7-daysA linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of cystatin C will be compared across the 7 day collection period between intervention and placebo arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 7-daysPopulation: Intention to treat
A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of chloride will be compared across the 7 day collection period between intervention and placebo arms.
Outcome measures
| Measure |
Lysine Chloride
n=22 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Lysine Chloride: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Placebo
n=18 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
Placebo: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
|---|---|---|
|
Change in Chloride
|
0.71 mmol/L per day
Interval 0.36 to 1.06
|
-0.87 mmol/L per day
Interval -1.32 to -0.43
|
SECONDARY outcome
Timeframe: Daily for 7-daysPopulation: Intention to treat
A linear mixed effect model will be used to analyze the trial with class variables of time and treatment group. Daily measures of bicarbonate will be compared across the 7 day collection period between intervention and placebo arms.
Outcome measures
| Measure |
Lysine Chloride
n=22 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Lysine Chloride: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Placebo
n=18 Participants
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
Placebo: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
|---|---|---|
|
Change in Bicarbonate
|
-1.02 mmol/L per day
Interval -1.35 to -0.7
|
0.19 mmol/L per day
Interval -0.16 to 0.55
|
Adverse Events
Lysine Chloride
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lysine Chloride
n=22 participants at risk
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Lysine Chloride group will receive the active intervention.
Lysine Chloride: Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
Placebo
n=18 participants at risk
Participants will be randomized to 7 days of therapy with either 115 mmol/day of lysine chloride or placebo. People in the Placebo group will receive placebo.
Placebo: Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride \& the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
36.4%
8/22 • Up to 7 days
|
11.1%
2/18 • Up to 7 days
|
|
Renal and urinary disorders
Renal failure
|
9.1%
2/22 • Up to 7 days
|
0.00%
0/18 • Up to 7 days
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Up to 7 days
|
5.6%
1/18 • Up to 7 days
|
|
Renal and urinary disorders
Acute kidney injury
|
4.5%
1/22 • Up to 7 days
|
0.00%
0/18 • Up to 7 days
|
|
Metabolism and nutrition disorders
Metabolic acidosis without acidemia
|
4.5%
1/22 • Up to 7 days
|
0.00%
0/18 • Up to 7 days
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
1/22 • Up to 7 days
|
0.00%
0/18 • Up to 7 days
|
|
Gastrointestinal disorders
GI bloating
|
0.00%
0/22 • Up to 7 days
|
5.6%
1/18 • Up to 7 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/22 • Up to 7 days
|
5.6%
1/18 • Up to 7 days
|
|
General disorders
Gout
|
0.00%
0/22 • Up to 7 days
|
5.6%
1/18 • Up to 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place