Trial Outcomes & Findings for Human Brain Natriuretic Peptide (BNP) (or Nesiritide) to Help Heart, Kidney and Humoral Function. (NCT NCT00405548)

NCT ID: NCT00405548

Last Updated: 2015-07-01

Results Overview

Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 41 participants
• Primary outcome timeframe: Baseline, 12 weeks
• Results posted on: 2015-07-01

Participant Flow

Participants were recruited at the Mayo Clinic in Rochester, Minnesota.

49 participants signed written informed consent to enroll in the study. Of these 8 were withdrawn prior to randomization for varying reasons.

Participant milestones

Measure	BNP (Nesiritide) Brain Natriuretic Peptide (BNP) 10 micrograms/Kg twice per day given subcutaneously for 12 weeks	Placebo Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Overall Study STARTED	28	13
Overall Study COMPLETED	24	12
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	BNP (Nesiritide) Brain Natriuretic Peptide (BNP) 10 micrograms/Kg twice per day given subcutaneously for 12 weeks	Placebo Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Overall Study Cognitive Memory problems on study day	1	0
Overall Study Amyloidosis on study echo-exclusionary	0	1
Overall Study Unable to self-administer shots	1	0
Overall Study Venous access failed during study day	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Human Brain Natriuretic Peptide (BNP) (or Nesiritide) to Help Heart, Kidney and Humoral Function.

Baseline characteristics by cohort

Measure	BNP (Nesiritide) n=24 Participants BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks	Placebo n=12 Participants Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	8 Participants n=7 Participants	25 Participants n=5 Participants
Age, Continuous	68.8 years STANDARD_DEVIATION 8.1 • n=5 Participants	69.6 years STANDARD_DEVIATION 10.9 • n=7 Participants	69.1 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	5 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	12 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Renal (or kidney) function was measured by the sodium or salt in the urine, following administration of a pre-specified amount of saline (salt).

Outcome measures

Measure	BNP (Nesiritide) n=24 Participants BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks	Placebo n=12 Participants Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Change in Urinary Sodium Excretion in Response to Saline Load	381.6 mEq/minute Standard Deviation 450.8	-10.5 mEq/minute Standard Deviation 90.1

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Urinary flow is a measure of renal (or kidney) function and was measured in milliliters per minute.

Outcome measures

Measure	BNP (Nesiritide) n=24 Participants BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks	Placebo n=12 Participants Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Change in Urinary Flow in Response to Saline Load	4.2 ml/minute Standard Deviation 5.4	-1.0 ml/minute Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Renal or kidney function was measured by GFR determined by iothalamate clearance. GFR describes the flow rate of filtered fluid through the kidney measured in milliliters per minute per 1.73 m^2 of body surface area. A lower GFR means the kidney is not filtering normally. An estimated GFR of less than 60 mg/ml/1.73 m^2 of body surface area is considered to be impaired kidney function.

Outcome measures

Measure	BNP (Nesiritide) n=24 Participants BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks	Placebo n=12 Participants Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Change in Glomerular Filtration Rate (GFR) in Response to Saline Load	6.8 ml/min/1.73 m^2 body surface area Standard Deviation 19.3	4.4 ml/min/1.73 m^2 body surface area Standard Deviation 27.3

SECONDARY outcome

Timeframe: Baseline, 12 weeks

LV diastolic function as measured by Doppler echocardiography. E/e' is the ratio of the mitral inflow velocity (E) to the mitral annulus tissue Doppler velocity (e'). A decrease in the ratio indicates a lower filling pressure and improved LV diastolic function.

Outcome measures

Measure	BNP (Nesiritide) n=24 Participants BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks	Placebo n=12 Participants Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Left Ventricular (LV) Filling Pressure Baseline LV Filling Pressure	14.9 E/e' Standard Deviation 4.1	14.9 E/e' Standard Deviation 4.5
Left Ventricular (LV) Filling Pressure 12 Week LV Filling Pressure	12.6 E/e' Standard Deviation 3.5	14.0 E/e' Standard Deviation 5.1

Adverse Events

BNP (Nesiritide)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	BNP (Nesiritide) n=24 participants at risk BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks	Placebo n=12 participants at risk Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
Gastrointestinal disorders Diarrhea	4.2% 1/24 • Number of events 1 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.	0.00% 0/12 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.
Cardiac disorders Heart Failure symptoms	0.00% 0/24 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.	8.3% 1/12 • Number of events 1 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.
Metabolism and nutrition disorders Hyperglycemia	4.2% 1/24 • Number of events 1 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.	0.00% 0/12 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.
Musculoskeletal and connective tissue disorders Joint pain	8.3% 2/24 • Number of events 2 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.	0.00% 0/12 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.
Skin and subcutaneous tissue disorders Rash	4.2% 1/24 • Number of events 1 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.	0.00% 0/12 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.
Cardiac disorders Hypotension	8.3% 2/24 • Number of events 2 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.	16.7% 2/12 • Number of events 2 • Baseline to 12 weeks during study with a 6 month follow-up telephone call to subject.

Additional Information

Dr. Horng H. Chen

Mayo Clinic

Phone: 507-538-2354

Email: chen.horng@mayo.edu

Results disclosure agreements

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