Trial Outcomes & Findings for Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction (NCT NCT00387621)

NCT ID: NCT00387621

Last Updated: 2012-05-17

Results Overview

Value at 60 minutes minus value at baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: baseline and 60 minutes
• Results posted on: 2012-05-17

Participant Flow

The study took place between February 2006 and August 2009. All subjects were consented and were seen at the Mayo Clinic in Rochester, MN.

63 participants were enrolled in the study, but 5 participants were excluded because they did not meet inclusion criteria. Participants included normal controls, Preclinical Systolic Dysfunction, and Preclinical Diastolic Dysfunction subjects, who were randomized into Placebo First, then Nesiritide (Arm A) and Nesiritide First, then Placebo (Arm B)

Participant milestones

Measure	Placebo First, Then Nesiritide (Arm A) In the first intervention period the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.	Nesiritide First, Then Placebo (Arm B) In the first intervention period the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
First Intervention STARTED	29	29
First Intervention COMPLETED	29	29
First Intervention NOT COMPLETED	0	0
Washout Period of 2 Weeks STARTED	29	29
Washout Period of 2 Weeks COMPLETED	29	29
Washout Period of 2 Weeks NOT COMPLETED	0	0
Second Intervention STARTED	29	29
Second Intervention COMPLETED	29	29
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Natriuretic Peptide System as Therapy in Human Preclinical Left Ventricle Dysfunction

Baseline characteristics by cohort

Measure	Control Group (Normals) n=20 Participants Healthy volunteers without heart disease	Preclinical Systolic Dysfunction Group (PSD) n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms	Preclinical Diastolic Dysfunction Group (PDD) n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms	Total n=58 Participants Total of all reporting groups
Age Continuous	37 years STANDARD_DEVIATION 11 • n=5 Participants	65 years STANDARD_DEVIATION 12 • n=7 Participants	72 years STANDARD_DEVIATION 7 • n=5 Participants	57.5 years STANDARD_DEVIATION 18.4 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	18 Participants n=7 Participants	9 Participants n=5 Participants	30 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	18 participants n=5 Participants	58 participants n=4 Participants
Creatinine	0.9 mg/dL STANDARD_DEVIATION 0.1 • n=5 Participants	1.1 mg/dL STANDARD_DEVIATION 0.2 • n=7 Participants	1.1 mg/dL STANDARD_DEVIATION 0.3 • n=5 Participants	1.0 mg/dL STANDARD_DEVIATION 0.2 • n=4 Participants
Blood Urea Nitrogen	11 mg/dL STANDARD_DEVIATION 5 • n=5 Participants	21 mg/dL STANDARD_DEVIATION 10 • n=7 Participants	23 mg/dL STANDARD_DEVIATION 6 • n=5 Participants	18.2 mg/dL STANDARD_DEVIATION 8.6 • n=4 Participants
Body Mass Index	25 kg/m^2 STANDARD_DEVIATION 4 • n=5 Participants	31 kg/m^2 STANDARD_DEVIATION 5 • n=7 Participants	30 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants	28.5 kg/m^2 STANDARD_DEVIATION 5.1 • n=4 Participants

PRIMARY outcome

Timeframe: baseline and 60 minutes

Population: per protocol

Value at 60 minutes minus value at baseline.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Change in Natriuresis (Urinary Sodium Excretion) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment	87.19 mEq/min Standard Error 22.26	—	—

PRIMARY outcome

Timeframe: Baseline, 30 min, 60 min

Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV) Urinary Sodium Excretion (Baseline/Pre-treatment)	186.6 uEq/min Standard Deviation 67.3	255.4 uEq/min Standard Deviation 189.2	202.1 uEq/min Standard Deviation 137.5
Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV) Urinary Sodium Excretion at 30 min	197.4 uEq/min Standard Deviation 80.8	221.0 uEq/min Standard Deviation 118.6	187.9 uEq/min Standard Deviation 110.3
Placebo Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UnaV) Urinary Sodium Excretion at 60 min	211.8 uEq/min Standard Deviation 89.5	231.1 uEq/min Standard Deviation 130.8	205.0 uEq/min Standard Deviation 130.5

PRIMARY outcome

Timeframe: Baseline, 30 min, 60 min

Subjects received subcutaneous placebo in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) Urinary cGMP Excretion (Baseline/Pre-treatment)	97.8 pmol/min Standard Deviation 124.8	219.5 pmol/min Standard Deviation 188.1	245.8 pmol/min Standard Deviation 198.7
Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) Urinary cGMP Excretion at 60 min	196.0 pmol/min Standard Deviation 182.6	134.1 pmol/min Standard Deviation 97.7	139.7 pmol/min Standard Deviation 118.6
Placebo Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) Urinary cGMP Excretion at 30 min	154.9 pmol/min Standard Deviation 141.7	133.3 pmol/min Standard Deviation 109.9	134.4 pmol/min Standard Deviation 114.4

PRIMARY outcome

Timeframe: Baseline, 30 min, 60 min

Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UNaV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV) Urinary Sodium Excretion (Baseline/Pre-treatment)	183.9 uEq/min Standard Deviation 58.1	232.6 uEq/min Standard Deviation 166.7	219.1 uEq/min Standard Deviation 201.7
Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV) Urinary Sodium Excretion at 30 min	393.4 uEq/min Standard Deviation 143.4	314.7 uEq/min Standard Deviation 225.3	303.2 uEq/min Standard Deviation 185.0
Nesiritide Pre-Treatment Urinary Sodium Excretion After Volume Expansion (UNaV) Urinary Sodium Excretion at 60 min	650.1 uEq/min Standard Deviation 337.9	469.4 uEq/min Standard Deviation 458.9	464.8 uEq/min Standard Deviation 272.7

PRIMARY outcome

Timeframe: Baseline, 30 min, 60 min

Subjects received subcutaneous Nesiritide in the abdomen. After 15 minutes, the acute saline load (volume expansion, VE) was administered. Subjects were asked to empty bladder spontaneously every 30 min (if unable to void every 30 min, a urinary catheter was placed). Adequate bladder emptying was insured by ultrasonography. UcGMPV was collected at baseline (immediately before VE) and at 30 and 60 min after initiation of VE.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) Urinary cGMP Excretion (Baseline/Pretreatment)	130.8 pmol/min Standard Deviation 145.9	192.2 pmol/min Standard Deviation 157.3	258.0 pmol/min Standard Deviation 176.2
Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) Urinary cGMP Excretion at 30 min	399.6 pmol/min Standard Deviation 252.6	388.6 pmol/min Standard Deviation 276.7	487.8 pmol/min Standard Deviation 634.0
Nesiritide Pre-Treatment Urinary cGMP Excretion After Volume Expansion (UcGMPV) Urinary cGMP Excretion at 60 min	508.4 pmol/min Standard Deviation 382.3	518.7 pmol/min Standard Deviation 578.3	475.0 pmol/min Standard Deviation 347.2

SECONDARY outcome

Timeframe: baseline and 60 minutes

Population: intention to treat (ITT)

Value at 60 minutes minus value at baseline

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Change in Urinary Cyclic Guanosine Monophosphate (cGMP) in Control Subjects at 60 Minutes After Volume Expansion Compared to Baseline in Response to Placebo Treatment	98.23 pmol/min Standard Error 34.12	—	—

SECONDARY outcome

Timeframe: 30 minutes

Population: intention to treat (ITT)

Value of natriuresis at 30 min on nesiritide treatment minus value of natriuresis at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Change in Natriuresis (Urinary Sodium Excretion) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment	440.93 mEq/min Standard Error 76.67	261.07 mEq/min Standard Error 101.60	242.82 mEq/min Standard Error 68.58

SECONDARY outcome

Timeframe: 60 minutes

Population: intention to treat (ITT)

Value of natriuresis at 60 min on nesiritide treatment minus value of natriuresis at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Change in Natriuresis (Urinary Sodium Excretion) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment	183.83 mEq/min Standard Error 60.60	226.89 mEq/min Standard Error 101.72	41.55 mEq/min Standard Error 46.07

SECONDARY outcome

Timeframe: 30 minutes

Population: intention to treat (ITT)

Value of cGMP at 30 min on nesiritide treatment minus value of cGMP at 30 min on placebo treatment (per subject group). The baseline was not involved in this calculation.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 30 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment	244.69 pmol/min Standard Error 59.09	255.31 pmol/min Standard Error 59.60	353.37 pmol/min Standard Error 155.65

SECONDARY outcome

Timeframe: 60 minutes

Value of cGMP at 60 min on nesiritide treatment minus value of cGMP at 60 min on placebo treatment (per subject group). The baseline was not involved in this calculation.

Outcome measures

Measure	Control Group n=20 Participants Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PSD-Preclinical Systolic Dysfunction n=20 Participants Participants with ejection fraction \<40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).	PDD-Preclinical Diastolic Dysfunction n=18 Participants Participants with an ejection fraction of \> 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
Change in Urinary Cyclic Guanosine Monophosphate (cGMP) at 60 Minutes in Response to Nesiritide Treatment Compared to Placebo Treatment	303.32 pmol/min Standard Error 71.21	384.62 pmol/min Standard Error 120.47	335.29 pmol/min Standard Error 90.48

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Nesiritide

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=58 participants at risk The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. As this was a cross over study, all participants received placebo and nesiritide.	Nesiritide n=58 participants at risk The first 10 subjects in each group received a dose of 5 ug/kg and the next 10 subjects received a dose of 10 ug/kg. As this was a cross over study, all participants received placebo and nesiritide.
Psychiatric disorders Panic Attack	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	1.7% 1/58 • Number of events 1 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.

Other adverse events

Measure	Placebo n=58 participants at risk The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. As this was a cross over study, all participants received placebo and nesiritide.	Nesiritide n=58 participants at risk The first 10 subjects in each group received a dose of 5 ug/kg and the next 10 subjects received a dose of 10 ug/kg. As this was a cross over study, all participants received placebo and nesiritide.
Cardiac disorders re-stenosis	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	1.7% 1/58 • Number of events 1 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.
Cardiac disorders heart palpatations	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	1.7% 1/58 • Number of events 1 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.
Cardiac disorders afibrillation	1.7% 1/58 • Number of events 1 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.
Cardiac disorders atypical chest pain	1.7% 1/58 • Number of events 1 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.
Gastrointestinal disorders diarrhea	3.4% 2/58 • Number of events 2 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.
Cardiac disorders hypotension	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	3.4% 2/58 • Number of events 2 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.
Renal and urinary disorders urinary urgency	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	1.7% 1/58 • Number of events 1 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.
Musculoskeletal and connective tissue disorders muscle fatigue	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	1.7% 1/58 • Number of events 1 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.
Gastrointestinal disorders esophageal reflux	1.7% 1/58 • Number of events 1 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.	0.00% 0/58 • Participants were followed for adverse events from the time of randomization until the completion of the second visit, approximately two months.

Additional Information

Dr Horng Chen

Mayo Clinic

Phone: 507-284-4343

Email: chen.horng@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place